Author: "Fourie A" / Topic: medicine.medical_specialty - Searchworks@Jio Institute Digital Library Search Results

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520 results on '"Fourie A"'

1. FDA Approval Summary: Tivozanib for Relapsed or Refractory Renal Cell Carcinoma

Author: Chana Weinstock, Laleh Amiri-Kordestani, Xiao Hong Chen, Elaine Chang, Eias Zahalka, Jeanne Fourie Zirkelbach, Shenghui Tang, Amna Ibrahim, Mallorie H. Fiero, Julia A. Beaver, Kirsten B. Goldberg, Vishal Bhatnagar, Miao Zhao, Paul G. Kluetz, Richard Pazdur, Tiffany K. Ricks, Jingyu Yu, Junshan Qiu, and Lijun Zhang
Subjects: Adult, Male, Sorafenib, Cancer Research, medicine.medical_specialty, Tivozanib, Urology, Administration, Oral, Article, law.invention, Randomized controlled trial, law, Renal cell carcinoma, medicine, Clinical endpoint, Humans, Adverse effect, Carcinoma, Renal Cell, Drug Approval, neoplasms, Aged, Randomized Controlled Trials as Topic, Aged, 80 and over, business.industry, Phenylurea Compounds, Middle Aged, medicine.disease, Rash, Kidney Neoplasms, Discontinuation, Survival Rate, Treatment Outcome, Oncology, Quinolines, Female, Neoplasm Recurrence, Local, medicine.symptom, business, medicine.drug
Abstract: On March 10, 2021, the FDA granted regular approval to tivozanib for treatment of patients with relapsed or refractory (R/R) advanced renal cell carcinoma (RCC) following two or more prior systemic therapies. Approval was based on the TIVO-3 study, a randomized trial of tivozanib versus sorafenib in patients with R/R advanced RCC. In TIVO-3, patients were randomized to receive either tivozanib 1.34 mg orally once daily for 21 consecutive days of every 28-day cycle or sorafenib 400 mg orally twice daily continuously. The primary endpoint was progression-free survival (PFS) per RECIST v1.1. Tivozanib demonstrated efficacy compared with sorafenib with an improvement in PFS [HR, 0.73; 95% confidence interval (CI), 0.56–0.95; P = 0.016]. The estimated median PFS was 5.6 months and 3.9 months in the tivozanib and sorafenib arms, respectively. There was no evidence of a detrimental effect on overall survival: HR, 0.97 (95% CI, 0.75–1.24). The most common grade 3 to 4 adverse reaction on the tivozanib arm was hypertension (24%). Compared with sorafenib, tivozanib was associated with lower rates of grade 3 to 4 diarrhea, rash, and palmar-plantar erythrodysesthesia. Patients receiving tivozanib in TIVO-3 had lower rates of dose reduction, interruption, or permanent discontinuation than those receiving sorafenib.
Published: 2022

2. FDA Approval Summary: Capmatinib and Tepotinib for the Treatment of Metastatic NSCLC Harboring MET Exon 14 Skipping Mutations or Alterations

Author: Xinyuan Zhang, Anup K. Amatya, Stacie Woods, Hong Zhao, Jeanne Fourie Zirkelbach, Runyan Jin, Mallorie H. Fiero, Jiang Liu, Pourab Roy, Huiming Xia, Youwei Bi, Erin Larkins, Claire E. Myers, Kelie Reece, Harpreet Singh, Kirsten B. Goldberg, Abdelrahmman M. Abukhdeir, Richard Pazdur, Shenghui Tang, Stephanie Aungst, Julia A. Beaver, Manuela Grimstein, Whitney S. Helms, Luckson Mathieu, Yangbing Li, Oladimeji Akinboro, Soma Ghosh, Reena Philip, Amy M. Skinner, and Pallavi S. Mishra-Kalyani
Subjects: Oncology, Cancer Research, medicine.medical_specialty, Lung Neoplasms, Exon, Overall response rate, Piperidines, Carcinoma, Non-Small-Cell Lung, Internal medicine, Humans, Medicine, Capmatinib, Triazines, business.industry, Fda approval, Imidazoles, Exons, Proto-Oncogene Proteins c-met, Confidence interval, Pyridazines, Pyrimidines, Benzamides, Mutation, Non small cell, Previously treated, business
Abstract: The FDA approved capmatinib and tepotinib on May 6, 2020, and February 3, 2021, respectively. Capmatinib is indicated for patients with metastatic non–small cell lung cancer (mNSCLC) whose tumors have a mutation leading to mesenchymal–epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test. Tepotinib is indicated for mNSCLC harboring MET exon 14 skipping alterations. The approvals were based on trials GEOMETRY mono-1 (capmatinib) and VISION (tepotinib). In GEOMETRY mono-1, overall response rate (ORR) per Blinded Independent Review Committee (BIRC) was 68% [95% confidence interval (CI), 48–84] with median duration of response (DoR) 12.6 months (95% CI, 5.5–25.3) in 28 treatment-naïve patients and 41% (95% CI: 29, 53) with median DoR 9.7 months (95% CI, 5.5–13) in 69 previously treated patients with NSCLC with mutations leading to MET exon 14 skipping. In VISION, ORR per BIRC was 43% (95% CI: 32, 56) with median DoR 10.8 months (95% CI, 6.9–not estimable) in 69 treatment-naïve patients and 43% (95% CI, 33–55) with median DoR 11.1 months (95% CI, 9.5–18.5) in 83 previously-treated patients with NSCLC harboring MET exon 14 alterations. These are the first two therapies to be FDA approved specifically for patients with metastatic NSCLC with MET exon 14 skipping.
Published: 2022

3. FDA Approval Summary: Osimertinib for Adjuvant Treatment of Surgically Resected Non–Small Cell Lung Cancer, a Collaborative Project Orbis Review

Author: Elitza Palazov, Yangbing Li, Harpreet Singh, Jeanne Fourie Zirkelbach, Julia A. Beaver, Dianne Spillman, Arūnas Girčys, Jiang Liu, Aleksandr Gamarian, Huiming Xia, Qiuyi Choo, Paz J. Vellanki, Pallavi S. Mishra-Kalyani, Nataliya Fesenko, Nicole Drezner, Ulrich-Peter Rohr, Richard Pazdur, Yuan Li Shen, Xiaoxue Li, and Abigail L. Koch
Subjects: Oncology, Cancer Research, medicine.medical_specialty, Lung Neoplasms, medicine.medical_treatment, Population, Placebo, Targeted therapy, Carcinoma, Non-Small-Cell Lung, Internal medicine, medicine, Adjuvant therapy, Humans, Osimertinib, Stage (cooking), education, Lung cancer, Protein Kinase Inhibitors, Acrylamides, education.field_of_study, Aniline Compounds, business.industry, medicine.disease, ErbB Receptors, Mutation, business, Biomedical sciences
Abstract: On December 18, 2020, the FDA approved osimertinib as adjuvant therapy in patients with non–small cell lung cancer (NSCLC) whose tumors have EGFR exon 19 deletions or exon 21 (L858R) mutations, as detected by an FDA-approved test. The approval was based on the ADAURA study, in which 682 patients with NSCLC were randomized to receive osimertinib (n = 339) or placebo (n = 343). Disease-free survival (DFS) in the overall population (stage IB–IIIA) was improved for patients who received osimertinib, with an HR of 0.20; 95% confidence interval (CI), 0.15–0.27; P < 0.0001. Median DFS was not reached for the osimertinib arm compared with 27.5 months (95% CI, 22.0–35.0) for patients receiving placebo. Overall survival data were not mature at the time of the approval. This application was reviewed under FDA's Project Orbis, in collaboration with Australia Therapeutic Goods Administration, Brazil ANVISA, Health Canada, Singapore Health Sciences Authority, Switzerland Swissmedic, and the United Kingdom Medicines and Healthcare products Regulatory Agency. This is the first targeted therapy adjuvant approval for NSCLC and has practice-changing implications.
Published: 2021

4. Risk factors for COVID-19-related in-hospital mortality in a high HIV and tuberculosis prevalence setting in South Africa: a cohort study

Author: Waasila Jassat, Cheryl Cohen, Stefano Tempia, Maureen Masha, Susan Goldstein, Tendesayi Kufa, Pelagia Murangandi, Dana Savulescu, Sibongile Walaza, Jamy-Lee Bam, Mary-Ann Davies, Hans W Prozesky, Jonathan Naude, Ayanda T Mnguni, Charlene A Lawrence, Hlengani T Mathema, Jarrod Zamparini, John Black, Ruchika Mehta, Arifa Parker, Perpetual Chikobvu, Halima Dawood, Ntshengedzeni Muvhango, Riaan Strydom, Tsholofelo Adelekan, Bhekizizwe Mdlovu, Nirvasha Moodley, Eunice L Namavhandu, Paul Rheeder, Jacqueline Venturas, Nombulelo Magula, Lucille Blumberg, Shaina Abdullah, Fiona Abrahams, Vincentius Adams, Fhima Adnane, Sonia Adoni, Dieketso Melitta Adoons, Veronique Africa, D Aguinaga, Susan Akach, Prisha Alakram Khelawon, George Aldrich, Olatunde Alesinloye, Mathale Biniki Aletta, Mametja Alice, Tebogo Aphane, Moherndran Archary, Felicity Arends, Shireen Arends, Munonde Aser, T Asmal, Mohammed Asvat, Theunis Avenant, Muvhali Avhazwivhoni, Magnolia Azuike, Johanna Baartman, Dlava Babalwa, Johan Badenhorst, Miranda Badenhorst, Bianca Badripersad, Lalihla Badul, M Bagananeng, Mncedisi Bahle, Liezl Balfour, T C Baloyi, S Baloyi, Tinyiko Baloyi, Tshepo Mpho Baloyi, Thokozani Banda, Shimon Barit, Nicole Bartsch, Junaid Bayat, Siyabulela Bazana, Marlene Beetge, Nosindiso Bekapezulu, Rammala Belebele, Phala Bella, Zanenkululeko Belot, Lindi Gladys Bembe, Sonja Bensch, Gishma Beukes, Karla Bezuidenhout, Themba Bhembe, N A Bikisha, Ben Bilenge, Leesa Bishop, Baphamandla Biyela, Cyntheola Blaauw, Mark Blaylock, Nicola Bodley, Power Bogale, Sibongile Bokolo, Stefan Bolon, Mary Booysen, Eldereze Booysen, Lia Boretti, Paula Borges, Millicent Boshoga, Natasha Bosman, Lucinda Bosvark, Nicky Botes, Adele Botha, Chantall Botha, Jana Botha, Chantall botha, Mandlakayise Irvin Botha, Alet Botha, Janet Bradbury, Zandisile Breakfast, Maria Breed, Molele Brenda, Moshito Brice, Jolene Britz, Amanda Brown, T Buchanan, Thozama Bucwa, Crystelle Burger, Ziyanda Busakwe, Nosiviwe Bushula, Zinhle Buthelezi, Dumsile Buthelezi, Thubelihle Buthelezi, Mpumelelo Basil Buthelezi, Fundiswa Lidwina Buthelezi, Nadia Bux, Christoff Buys, Anneline Buys, Ernestina Caka, Armando Sanchez Canal, Sithole Caroline, Monrick Casper, Shannon Cawood, Oratile Cebisa, Nothando Cele, Sboniso Cele, Sthembile Goodness Cele, Mkhacani Chauke, Pinkie Chauke, Nevil Chelin, Xiaohui Chen, Venmalla Chetty, Kerisse Chetty, Christinah Cheu, Vindana Chibabhai, Takudzwa Chirima, Mantwa ChisaleMabotja, Charity Chivenge, Ngoasheng Choene, Mbali Nosisa Choko, Martin Choshi, Sabbir Chowdhury, Anastacia Christoforou, S L S Chuene, T S Chueu, Dale Cilliers, Vanessa Cilliers, Marcel Claassen, Jeané Cloete, Chantelle Coelho, Carol Coetzee, Hans Jurgens Coetzee, Christine Coetzee, Marelize Coetzee, Dane Coetzer, Sizwe Coka, M Colane, Herkulaas Combrink, Songezo Conjwa, Colleen Contrad, Faith Cornelissen, Leezelle Cronje, Christine Crouse, Tshidi Dabi, Ziyanda Dandala, Ziyaad Dangor, Gildenhuys Daniel, Ngwana Daniel, Alfred Daumas, Madelein Dauth, Mongalo David, Wayne Davids, Nozuko Daweti, Wandisa Dayile, B De Bruin, Karin De Klerk, Tanya De la Rosa, Marice de Nysschen, Marie De vos, Darien De Wet, Mohith Debising, Darshan Deenadayalu, Babalwa Dekeda, Mofokeng Desiree, Annelise Deysel, Abram Dhlamini, Makgethwa Dhlala Diala, Mathapelo Diale, Bella Diketane, Nosisa Dingani, Siyabonga Diniso, Lesego Diphatse, Anele Diya, Zihloniphile Dladla, Nompumelelo Dladla, Mlungisi Dladla, Patience Dladla, Baphilie Dlamini, Nonhlanhla Dlamini, Linda Dlamini, Nonzwakazi Dlamini, Wendy Dlamini, Ncomeka Dlamini, Siyabonga Dlamini, Nicodemus Dlamini, Lebohang Dlamini, Motshedise Dlamini, Babalwa Christine Dlava, Phikiwe Dlova, Lindiwe Dlozi, Maenetja Doreen, Vumile Doyi, Athini Doyi, Belinda Du Plessis, Johanna Aletta du Plessis, Eddie du Plessis, Nicolette du Plessis, Karin du Plessis, Briette du Toit, Narissa du Toit, Jabulile Dube, Athayanda Dubula, Msomi Duduzile, Sechaba Duiker, Unati Bongile Duma, Kholiwe Duma, Kella Dunne, Kholeka Dyantyi, Avile Dyantyi, Simphiwe Dyasi, Chauke Dyondzo, Phelisa Dyubhele, B J Dywili, Letitia Edwards, Madie Eksteen, Tersia Ellis, Tia Ellis, Glenda Emmerson, Theusia Enslin, Odimula Epule, Lana Erasmus, Mathonsi Erick, Lerato Etsane, Shimange Eunice, Zanele Fani, Mariette Ferreira, K L Finger-Motsepe, Fabion Floris, Tseko Fobo, Keresemetse Fokotsane, Duduzile Emmelda Fokwana, Genevieve Marion Fords, Juanita Fortein, Christine Fouche, Rulandi Fourie, Andrew Frean, Ludwig Fredericks, Wandile Funda, kabelo funjwa, Martha Futhane, Amanda Futuse, Dora Gabaediwe, Nonhlanhla Gabuza, Janycke Galant, Zanele Gama, Thobile Gano, Emma Cora Gardiner, Henri Gastrow, Kelly Gate, Ben Gaunt, Rikhotso Gavaza, Thapelo Gayi, Nkosinathi Gcakasi, Nomusa Gcobo, Leon Geffen, S Geldenhuys, Jenny George, Martha Gerber, Zolisa Getyengana, Nkululo Gigi, Radha Gihwala, Mitchell Gilliland, Zandile Gloria, Elitia Glover, Ellen Gokailemang, Suseth Goosen, Maria Gopane, Thandazile Gosa-Lufuta, Bernadett Gosnell, Sharleen Gouws, Christina Govender, Raksha Govender, Pearl Govender, Sally Govender, Roxanne Govender, K Govender, Savie Govender, Rashika Govinden, Luphumlo Gqabuza, Nomthandazo Gqaji, Maneo Gqetywa, Caroline Green, Nathan Green, Neera Green, Hendrik Grobler, Pamela Groenwald, Daniel Grootboom, Beatrice Gumede, Nomonde Gumede, Simphiwe Gumede, Slindile Gumede, Ntombikayise Gumede, Zenande Gumede, Thandiswa Gxotiwe, Makhubela H L, Nonhlanhla Hadebe, Skhumbuzo Hadebe, Christos Halkas, Ansie Hamer, Ebrahim Hamida, Juan Hammond, Sumayia Haniff, Annelise Hare, lorinda Hattingh, Thenjiwe Hendricks, Philip-George Henecke, Brends Henly-Smith, Glynis Herselman, Ansie Heymans, Chantel Heyns, Golekane Hlabahlaba, Lucky Hlabangwane, Simango Hlamarisa, Ntokozo Hlanzi, Hlengiwe Hlela, Katlego Hlokwe, Thembinkosi Hlongwa, Anele Hlongwana, Themba Hlubi, Tozama Hobo, Nare Nathaniel Hopane, Mariska House, Catharina Hudson, Marinda Huysamen, Jezreen Indheren, Samantha Ingle, Gavin Isaacs, T S Thekiso Isaacs, Maringa Itumeleng, Karien J van Rensburg, Saloshni Jackson, Neziswa Jacob, Burton Jacobs, Tshireletso Jacobs, Gugulethu Jacobs, Mesadi Jaftha, Zimkhitha Jaji, Sibusiso Jali, Gcobisa James, Gillian January, Andiswa Jeke, Laurent Jeremiah, L S Jeremiah, Mubeen Jhetam, Maureen John, Chuene John, Thandiwe Jola, Yolande Jonas, Anovick Jonas, Amilcar Juggernath, Eileen Kaba, Venetia Kabo, Disebo Kadi, Karabo Kaizer, Moshaya Peter Kambule, Lorraine Kapp, Tshepo Kau, Nchabeleng Keneth, O Kgabi, Tebogo Audrey Kgafela, Vincent Kgakgadi, Isabella Kgaswe, Tsholofelo Kgathlane, Vuyelwa Julia Kgetha, Mmaselloane Kgomojoo, B Kgoro, Christinah Kgosiemang, Gloria Kgosiencho, Stephen Khambula, Ariffa Khan, Refemetswe Khanare, Ncamsile Khanyase, Nokwethemba Khanyile, Fillip Kharatsi, Simangele Khawula, Themba Khohlakala, Letitia Khomo, Isabel Khoza, Sinethemba Khoza, Nombulelo Khukule, Busisiwe Khumalo, Tracy Khumalo, Zinhle khumalo, Vuyelwa Khumalo, Delisile Khumalo, Lebohang Khumalo, Boitumelo Khumalo, Thuli Khumalo, Gugu Khumalo, Bongiwe Khuzwayo, Thembhelihle Khuzwayo, Hennie Kidson, Jesne Kistan, Gugu Klaas, Marilyn Klassen, Josehine Koeberg, Marizel Koen, Simphiwe Koena, Ina Kok, Imraan Kola, Karabo Kolokoto, Ramachandra Konar, Dr Kotsedi, Jaline Kotze, Martins Koupis, Helen Kritzinger, Marlize Kruger, Henk Kruger, Tlangelani Kubayi, Thabisile Kubeka, Nonjabulo Kubheka, Melusi Kubheka, Sibusiso Clifford Kubheka, Erol Kubheka, Monica Kumalo, Thulani Kunene, Siphilile Candy Kunene, Yvette Kunneke, R P Kupa, Rachel Kutama, Nompumelelo Kwakwazi, Lwanele Kweyama, Maureen Labuschagne, Marina Labuschagne, Prabha Lakshman, Lungelo Lamani, Thembela Lamani, Naomi Langa, Khangelani Langeni, Aphelele Langeni, Nwabisa Hazel Langeni, Gena Langeveldt, Anchen Laubscher, Laetitia Le Roux, Magagane Leah, Collen Lebea, Sello Lebea, Viyella Phumla Cynthia Lebenya, Lorraine Lebogang, P K Leboho, Chantel Lee, Kelebogile Rejoice Lefakane, Zandile Legoabe, Patrick Lekala, Motsitsi Lekhoaba, Tanki Shadrack Lekunutu, Galaletsang Lerefolo, N Letebele, Tsepo Patric Lethoba, Emission Letlalo, Ofentse Letlhage, D S V Letshufi, Dineo Fiona Letsoalo, Seleka Jones Letsoalo, Pennelope Letsoalo, Getrude Letwaba, Sobekwa Linda, Katleho Lipholo, Sabata Litabe, Harsha Lochan, Linda Lomax, Francina Lombaard, Elmarie Loots, Ariana Lourens, Celeste Louw, Rianna Louw, Zikhona Lubambo, Msebenzi Moises Lubambo, Gregory Ludada, Michael Lukas, Thembela Lungu, Nomvume Lupindo, Emmah Lusenga, Happiness Luthuli, Zoleka Sylvia Luvuno, Gwangwa M H, Mustafa Maarman, Buyisiwe Mabaso, Cynthia Mabaso, Morena Mabitle, Grace Mabogoane, Kgakgamatso Mabone, Rueben Mabuza, Velaphi Mabuza, Mogantla Madiseng, Thobile Madlala, Mashooase Madolo, Thabiso Madonsela, Lesetsa Madubanya, Amukelani Maepa, Namhla Mafumana, Caroline Mafumo, Pumeza Magadla, Viscah Magale, Nompumelelo Magaqa, Oberholzer Magda, Rakgoale Magdeline, Tswai Maggie, Bongeka Maginxa, Cathrine Maite Magoba, Caroline Magongwa, Agretia Magubane, Agretia Ntombizodwa Magubane, R Magwai, D I Mahabane, Padmini Mahabeer, Elsie Mahadulula, Lungiswa Mahanjana, Amy Maharaj, Qedusiza Mahlambi, Yvonne Mahlangu, Lerato Mahlangu, Ntombifikile Mahlangu, Makhosazana Mahlangu, Mahlatsi Mahlangu, Penelope Mahlasela, Thosago Mahlatse, Regina Mahlobo, Dikhing Mahole, Adam Mahomed, Mapeu Debora Mahubane, Peter Mahume, Lehlogonolo Maifo, Vincent Maimane, Petunia Maimele, Phakoe Maine, Patricia Senyanyathi Mainongwane, Nomalungisa Majamani, Amahle Majozini, Noluthando Makalima, Nomfundo Makam, Khanyisa Makamba, R Makan, Mashiane Makarapa, Malesela Makgahlela, Mogoiwa David Makgisa, Makgoba Makgomo, M A Makgopa, Mabone Makhalema, Lindokuhle Lizo Makhanya, Philile Valentia Makhanya, Tolerance Makharaedzha, Nathi Makhathini, Elizabeth Makhesi, Cinile Makhubela, Nkululeko Freedom Makhunga, Nomalinge Makhupula, R R Makhura, Rangwato Makola, Zingisa Makuba, Asanda Makubalo, Lonwabo Makumsha, George Makuya, Levy Mmachuene Malaka, Themba Malangeni, M L Malatji, Pelonomi Malebana-Metsing, Malek Malek, Luthando Malevu, Juanita Malgas, Dimakatso Malgas, Paul Makgasane Malope, Monyeki Malose, Katekani Maluleke, Kato Mambane, Nthabiseng Mamorobela, Kukami Manamela, Tshepo Manana, Sathiel Maneto, Aron Kabelo Manganye, Pheto Mangena, Anna Mangoale, Tinotenda Florence Mangozho, Pariva Manickchund, Zandisile Mankayi, Arthur Manning, Kelebogile Manyaapelo Manyaapelo, Tabea Manyane, Zoliswa Manzana, Milton Manzini, Busisiwe Mapasa-Dube, Siboniso Maphumulo, Ntombifuthi Maphumulo, Sindy Maponya, Khomotso Mumsy Maponya, Napjadi Maponya, Lami Maqubela, Lizeka Maqubela, Vuyo Maqungo, Marisa Marais, Chantal Marais, Nondumiso Maramba, Annelize Mare, Madumetsa Maredi, Afikile Martins, Johanna Marule, Refilwe Marumo, N N Masakona, Kedibone Vincentia Masehla, Eric Maseko, Tshilidzi Maselesele, Mojalefa Maselo, M Maseloa, M E Masemola, Thembi Masemola, Bella Mashaba, James Mashangwane, Mantebele Mashao, Shalom Mashego, Lerato Mashele, Ester Mashiane, Joyce Mashibini, J Mashilo, Tumi Mashiloane, Charity Mashishi, Ngazibini Mashiyi, Khomola Mashudu, Aluwani Masindi, Caroline Maslo, Nduduzo Masondo, Dumisile Masuku, Cry Matamela, Mirriam Matandela, Nontokozo Mathabela, T Mathabi, Keitumetse Mathe, Mathabo Mathebula, Catherine Mathebula, Mdungazi Andres Mathebula, Nqobizwe Mathenjwa, Jane Mathibe, Lebohang Mathibela, Makwela Mathilda, Khakhu Mathiva, Mokgadi Alinah Mathobela, Fikile Pearl Mathonsi, K P Mathonsi, Katlego Mathosa, Noluvo Matiwane, Emma Matjeke, Bella Matjiane, Thabang Matjila, Chidi Matlala, Petlo Matome, Nolusindiso Matoti, C Matseliso, Dineo Matsemela, Phumeza Matsha, Gaalebale Prudence Matshediso, Motsumi Matshediso, Esther Matshela, Bongeka Mavuma, Pearl Mavundla, Nomthandazo Mavuso, Lovender Mawasha, Rebecca Mawelela, Nelisiwe Mazibuko, Phumlani Mazibuko, Lindiwe Mazubane, Bavumile Mbanjwa, Ayanda Mbasa, Nosimilo Mbatha, Zanele Mbatha, Rudolph Zenzele Mbatha, Gift Mbedzi, Tatenda Trevor Mbizi, Khumbulani Mbonambi, Nondumiso Mboniswa, Nomfanelo Mbonisweni, Jody Mbuilu, Siyabonga Mbulawa, Zama Mbutho, Natasha Mbuzi, Nonkululeko Mchunu, Cyprian Mchunu, Nokuzola Mchunu, Masesi Thandeka Mchunu, Vuyokazi Mciteka, Solly Mdaka, Neho Mdakane, Siyabonga Mdediswa, Melusi Mdima, Nozipho Mdima Masondo, Siviwe Mdindana, Ntombizikhona Mdleleni, Sibusiso Mdletshe, Gcobisa Precious Mdoda, Ntombi Mdolo, Anele Mdontsane, Ruchikas Mehta, Philile Rittah Memela, Masande Methuse, Keatlaretse Metshile, Pheliswa Metuse, Anton Meyer, Gavin Meyer, Cameron Meyer, Sisonke Mfazwe, Andiswa Mfecane, Bongeka Mfecane, Nelisiwe Mfeka, Busisiwe Mgaga, Thandiwe Portia Mgauli, Thembekile Mgedezi, Vuyokazi Mgedezi, Kalipile Mgevane, Bongni Mgiba, Babalwa Mgoduka, Patrick Mhlaba, Zeldah Mhlaba, Ntombizodwa Mhlanga, Vangile Mhlinza, Nokuthula Mhlongo, sibongiseni Mhlongo, Unamandla Mhlotshana, Mabaso Mikateko, Helena Minnie, Karen Mintoor, Bongi Miyeni, Mabelane M J, Rosy Mjethu, Gloria Mkhize, Mvuselelo Mkhize, Ntokozo Siyabonga Mkhize, Victoria Mkhize, Nomkhosi Mkhize, Nokuthula Mkhize, Mathini Mkhwanazi, Nolwandle Mkile, Kholofelo Mkise, Nokwandiso Mkiya, Pearl Mkongi, Mnonopheli Mkungeka, Hlomile Mlahleki, Nolukholo Mlibali, Sakhumzi Mlungwana, Jonas Mmachele, Mashatole Mmateka, Molebatsi Mmokwa, Thembisa Mmutlane, Zanele Olive Mndebele, Nonhlanhla Mngomezulu, Noluthando Millicent Mnguni, Pumza Mngunyana, Nomxolisi Mngunyana, Ntombebongo Mngxekeza, Zenzele Mnisi, Hlengiwe Precious Mnqayi, Phumzile Mnqayi, Thabiso Mntungwa, Siya Mnyaka, Ntombikayise Mnyakeni, Vuyani Mnyamana, Nomzingisi Mnyipika, Koena Moabelo, Mmakgoshi Alseria Moatshe, Jennifer Mochaki-Senoge, Sharon Moche, Tebello Mocwagae, Koeikantse Modibane, Tebogo godfrey Modimoeng, Obakeng Modisa, Itumeleng Modisane, Olebogeng Modise, Makaepeaa Flovia Modjadji, Sharon Modupe, Maja Moeketsi, Ntswaki Moeketsi, Kereditse Kingsley Moeng, Naledi Nthabiseng Mofamere, Samuel Mofokeng, Thabo Mofokeng, Jonas Mofomme, Vicky Mogakane, Lehlohonolo Mogale, Audrey Mogapi, Thomas Mogashoa, Mphaka James Mogatla, Kgaladi Mogoale, Dikeledi Maggie Mohajane, Nkuba Mohapi, Mthoamihla Mohatsela, Irene Mohlala, Daphney Mohlala, Mpho Mohlamonyane, Bonolo Millord Mohutsiwa, Selemela Moipone, Tshepang Moisi, Nelly Mojalefa, Vuyo Moji, Buhle Mokangwana, Matloa Mokgabo, Manaka Mokgaetji, Jane Mokgaotsi, Neo Theodore Mokgoro, Thalitha Mokhatla, Lerato Lovedalia Mokhele, Sheila Mokhema, Mamoya Mokoena, Mojalefa Mokoena, Lleka Mokome, Cynthia Mokone, Ipeleng Mokono, Thabiso Mokonyama, Josiah Mokori, Dolores Mokuena, Danny Mokumo, Oddy Mokwena, Kgaogelo Mokwena, Kgantshi Sam Mokwena, Lebogang Mokwene, Thato Elliott Molate, Ditoche Molebalwa, Boingotlo Molefe, Kgopa Stanley Molehe, Kgomotso Moleme, Sarah Moliane, Fanyana Moloi, Retshepile Joseph Molorane, Glenda Tsholanang Molotsi, Lerato Molukanele, Joy Monareng, Thapelo Moncho, Modiadie Monica, Refilwe Monnane, Andile Monqo, Neo Montewa, Kgalalelo Montsioa, Reitumetse Monyaki, Masekhobe Jeanett Monyane, Lipson Monyela, Yudeshan Moodley, Kriesen Moodley, Kaira Moodley, Boitumelo Donald Mooka, Prea Moonsamy, Simmi Moopanar, David Moore, Lineo Mophethe, Tshegohatso Moremedi, Kealeboga Moremong, Nthangeni Morgan, Egma Moripa, Lulamile Morris, Me. A.M. Mosala, Thabo Mosana, Alice Mosase, Yolanda Mose, Maponya Mosehlo, Mothusi Moseki, Mojalefa David Moshabe, D A Moshai, Mbulelo Moshani, Pelisa Moshani, Ledwaba Mosima, Ezrom Mosima, M P Mosoma, Lebohang Motaung, Mokete Motaung, Thozama Charmain Motaung Xhama, Purine Khethiwe Motha, Lerato Motimele, Boitumelo Motimeng, Shirley Motladiile, Otsile Motlhabane, Joshua Motlhamme, Mandla Motloba, Kagiso Motse, Sophia Motshegoa, Edward Moutlana, Irma Mouton, Zanele Moya, Nomonde Moyake, Maja M P, Jenny Mpete, Luamba Meltha Mpfuni, Seputule Mphahlele Mphahlele, Mashadi Mphake, Ephraim Letlhogonolo Mphanya, Mashudu Mphaphuli, Tebogo Chwene Mphela, MS Mpontshane, Thabile Mqotyana, Babalwa Mqungquthu, Noluthando Busane Msane, Malusi Mseleku, Sibusiso Msibi, Mancele Msibi, Thulisile Msibi, Siyabonga Linda Msibi, Clement Nhlanhla Msiza, Lungelo Msomi, Mandlenkosi Mtatambi, Thembisa Mthathambi, December Mthembu, Nhlahla Mthembu, Fezile Mbali Mthembu, Lungiswa Mthembu, Nompumelelo Petunia Mthethwa, Khulekani Mthimkhulu, Lungani Percival Mthuli, Ashley Mthunzi, Xolani Sydney Mtolo, Nomonde Precious Mtolo, Linda Mtshali, Neliswa Mtwa, Fezeka Mtyobile, Kanyisa Mtyobile, Mpfariseni Mudau, Magwabeni Muemeleli, Isaac Mulaudzi, Rebecca Mulaudzi, Mhlelekedzeni Mulaudzi, Dakalo Rejoyce Muligwe, Blessing Muponda, Mmbangiseni Stella Mushadi, M Mushid, Konanani Muthaphuli, J Muthavhine, Mpho Muthika, Samkelisiwe Mvelase, Vusi Mvelase, Laurent Kayumba Mwehu, Thabile Myaka, Magriet myburgh, Zimkhitha Mzamo, Fezeka Mzawuziwa, Mfundo Lunga Mzini, Oscar Mzizana, Ntokozo Mzobe, Thokozile Mzobe, Zamaswazi Mzobe, Mtimkulu Mzwandile, Fathima Naby, Keshnee Naicker, Pregashnie Naicker, Saroja Naicker, Pershen Naicker, Saiyen Virgil Naicker, Ria Naidoo, Sam Naidoo, Mergan Naidoo, Kamalambal Naidoo, Aroomugam Naidoo, Sivuyile Naku, Firdose Nakwa, Masoga Nancy, Rita Nathan, Maritsa Naude, Gcobisa Ncaza, Aviwe Ncaza, Relebohile Ncha, Yanelisa Ncoyini, Snothile Ncube, Mrs Ndaba, Vusumuzi Ndaba, Mmapula Ndaba, Siziwe Ndawonde, Ziphozihle Ndevu, Nonhlanhla Faith Ndhlovu, Simphiwe Ndima, Sindisiwe Ndlela, Thobsile P Ndlela, Nobuhle Ndlovu, Nwabisa Ndlovu, Virginia Dipuo Ndlovu, Sombekhaya Ndlumbini, Khululiwe Nduli, Priscilla Nontokozo Nduli, Michael Ndwambi, Jeremy Nel, Rina Nel, Lizelle Nel, Ntsundeni florah Nemanashi, Usinkhangwe Nyaphophi Nemudivhiso, Joyce Nemutavhanani Nemutavhanani, Jabu Nene, Xolani Nene, David Netshilonga, Rendani Netsianda, Charmaine Newton, Vuyo Leroy Ngalo, Ncumisa Ngani, Thabisa Monica Ngcakaza, Thamela Ngcobo, Trulove Nonhlanhla Ngcobo, Richards Ngcobo, Gcinile Ngcobo, Guguletu Ngcobo, Thozama Ngetu, Pinkie Ngewu, Tshepo Ngobeni, Providence Ngobeni, Khanyisile Ngobeni, Prudence Ngobeni, Thembisile Ngobese, Tracy Ngomane, Nolusindiso Ngondo, Nokukhanya Ngubane, Sithembiso Ngubane, Ntombizodwa Praxedise Nguse, Tholakele Ngwane, Elizabeth Ngwasheng, Siphamandla Ngwenya, Gugu Ngwenya, Nomthandazo Ngwenya, Themba Ngwenya, Eva Ngwenya, Zintlanu Ngxola, Tshegofatso Nhabe, Jabulile Nhlabathi, Ishmael Nhlangwana, Sithembile Nhlapo, Matlala Nick, Vicky Niemand, Carina Nienaber, Louise Nix, Chumisa Njikelana, Masiza Njomi, Lucia Nkabinde, M NKABINDE, Boitumelo Nkabiti, Gugu Nkabule, Mankopodi Nkadimeng, Nonkanyiso Nkanjeni, Palesa Portia Nkatlo, Bongani Nkewana, Audrey Nkhwashu, Ngokoana Nkoana, Mmathapelo Nkoane, M Nkogatse, Fezile Nkomo, Ntando Nkomo, Nontobeko Nkonyane, Sydney Nkosi, Ntombikayise Nkosi, Phumzile Nkosi, Ntombifuthi Nkosi, TINTSWALO NKOSI, ML Nkosi, Godfrey Nkosi, Amukelani Nkosi, Fikile Vinoliah Nkosi, Mbali Nkosi, Nomcebo Lucia Nkosi, Siphokazi Nkosi, Amanda Nkuhlu, Phumzile Nkumane, Malebo Nkuna, Wendy Nkwakwha, Sesi Noge, Elizabeth Nolte, Peko Nomawabo, Malibongwe Nombita, Nandipha Nophale, Jeanetta Nothnagel, Bongiwe Novokoza, Zanele Nqaphi, Thobekile Nqondo, Siphokazi Nqwelo, Nkoana N S, Sindiswa Ntabeni, Mr Ntabeni, mawethu Ntampula, Mthutuzeli Ntebe, Mokwabo Ntela, Hezekiah Ntimbane, Xolisa Ntintsilana, Patrick Ntleki, Zanele Ntobela, Bandile Ntombela, Zamaswazi Ntombela, Khonelihle Zandile Ntombela, Praisegod Samkelo Thobani Ntombela, Lindiwe Ntonintshi, Dipuo Ntseane, Thobeka Ntseane, Xolelwa Ntsham, Mbalenhle Ntshele, Amanda Ntshewula, Zinzi Ntsoko, Athini Ntsoto, Nomsa Ntuli, Nokwazi Ntuli, Nomvula Ntuli, Andrew Diffar Ntuli, Faith Ntuli, Margrit Nurnberger, Ntsikelelo Nxala, Sithandiwe Nxasane, Thanda Nxumalo, Xolani Nyathi, Nontobeko Nyawula, Nhlakanipho Nzama, Maila Nkuneng Obed, Florence Ogwal, Maureen Olifant, B Oliphant, Monota Olive, Kagisho Olyn, Raymond Omoighe, Phumeza One, Ratombo Oscar, Nkuna Owen, Mailula P, Nalini Padayachee, Vasaily Padayachy, Ntombizakhe Pakade, Mosiuoa Palime, Jane Palisa, Lesenyeho Parkies, Andy Parrish, Nilesh Patel, Anastasia Pather, Mkhombo Tsakani Patience, Marisa Patzke, Akhumzi Pawuli, Ntandokazi Pelako, Phaswana Sibasa Penrose, Litha Peppeta, Santosh Pershad, Makheda Pertunia, Nkuna Pertunia, Dane Perumal, Mongameli Peter, Justin Peters, Vatiswa Petlane, Harideen Petrus, Kgomotso Phahladira, Matebesi John Phakisa, R Phale, Livhuwani Phathela, Sekate Daniel Phillip, Beverly Phiri, Mapule Precious Phiri, Thapelo Phokane, Frank Phokoane, Moele Pholosho, Sekoro Phooko, Sekodi Geoffrey Phooko, Maponya Phutiane, Faiza Pillay, Melanie Pillay, Sayuri Pillay, C R Pillay, Zikhona Plaatjie, James Pootona, Samantha Potgieter, Marius Potgieter, Mulaudzi Mulatedzi Precious, Paul Janus Pretorius, Hans Prozesky, Mokhethi Pule, Jayshina Punwasi, Dot Putzier, Lutho Qankqiso, Siphokazi Qebedu, Phozisa Qhola, Ntombesithathu Qotoyi, Sipho Victor Qotso, Zanele Qwabe, Helena Rabie, Phoebe Rabothata, Christina Rachoene, Mteteleli Radana, Maria Radebe, Dr. Valentino Radebe, Nonkululeko Radebe, Ella Radinne, Sherly Raduvha, Shamintha Raghunath, Claudine Rajagopaul, Mary Rakgwale, Malumbete Michael Ralethe, Kenneth Ralimo, Motlalepule Ramafoko, Maduvhahafani Ramagoma, Charlotte Raman, Dr Ramavhuya, Molly Rambally, Nivasha Ramdeen, Tanusha Ramdin, Sharita Rameshwarnath, Yeishna Ramkillawan, null Ramotlou, Faith Rampedi, Vijayluxmi Rampersad, Avhashoni Ramuima, Noluthando Ranone, Mabohlale Portia Rapasa, Mpharoane rapelang, Nika Raphaely, Lesiba Rashokeng, Caroline Rashopola, Tebogo Ratau, M Ratau, Mpfariseni David Ratshili, Elmari Rautenbach, Rofhiwa Ravele, Johannes Reachable, Peta Mmalahla Rebecca, Kessendri Reddy, Andrew Redfern, Robertha Reed, Mumsy Rees, Dr Reji, Gary Reubenson, Veena Rewthinarain, Nkonayani Rhulani, Mufamadi Richard, J S Rikhotso, Shatimone Beverley Rikhotso, Lavhelani Ndivhaleni Robert, Noncedo Roto, Gideon Ruder, Kapil Rugnath, Lizette Ruiters, Mina Ruiters, Sue Russell, Lynn Ruwiza, Molokoane R Y, Mandy Saaiman, Emmanuel Sabela, Lerato Sadiq, Litha Saki, Hyppolite Salambwa, Menitha Samjowan, Nazlee Samodien, Rakgolele Samuel, Fakudze Sandile, Cekuse Sanelisiwe, Mandlankosi Sani, Simangele Sawuka, Lelani Schoeman, Magriet Scholts, Ronel Schroder, Mamotetekoane Sebalabala, Selwalenkwe Collet Sebati, Jacoline Seboko, Wilheminah Sebuthoma, Annah Segami, Ruth Segokotlo, MR Sehloho, Khutjo Seisa, Antony Sekgobela, Monica Sekhosana, John Sekonyela, Mpho Sekoto, Naledi Sekulisa, Mokgadi Vanessa Sekwadi, Lebogo Selaelo, Johannes Selatlha, Kgomotso Selekolo, William Selfridge, Lucy Semenya, Ivy Sengakane, Masabata Sengata, Petronella Sentle, Malebo Seoketsa, Pratheesha Seonandan, Thomas Mambushi Serumula, Nkululeko Setheni, Refiloe Setlale, Tumediso Setlhodi, Barbara Setlhodi, Robert Setloghele, Aarthi Sewpersad, Ryan Sewpersadh, Phumlile Shabalala, Owen Shabangu, Kungesihe Shabangu, Harriet Sbonangaye Shabangu, Thokozani Shabangu, Clifford Shadi, Hasifa Shaik, Tseliso Shale, Qedani Shandu, Nomvelo Shandu, Ntswaki Marcia Shange, Abongile Shenxane, A Sherriff, Sebenzile Shezi, Thenjiwe Shezi, Scally Shihangule, Cheyeza Shikwambana, Lungisani Shoba, Kamogelo shokane, Nora Sibande, Lydia Sibeko, Xolani Sibeko, Zanele Sibiya, Mncedisi Sibiya, Sphamandla Sibuta, Thembakazi Sifumba, Sipho Sigcau, Lutho Sigila, Kayakazi Sihentshe, Bongani Sihlangu, Daisy Sikhakhane, Shaun Nhlanhla Sikhakhane, Mbali Siko, Sipho Sikonje, Khumbulekile Simanga, Nomsa Simango, Thulisile Simela, Ntombikayise Simelane, Sashah Singh, Marjorie Singh, Ragani Singh, Shash Singh, Anita Singh, Hitekani Sithole, Senzekile Sithole, Ntokozo Danielle Sithole, Koketso Maxwell Sithole, Jonnie Situma, Annie Sivraman, Katekani Siwela, Nonqubela Siyewuyewu, Maweya Sizeka, Nonceba Siziba, Andrew Skhosana, Khanyisile Skhosana, Rorisang Skhosana, Tandiwe Skoko, Sunet Slabbert, Ntombela Smangaliso, Christine Smedley, Lydia Smit, Natassia Smit, Lizelle Smit, Michelle Smit, Fasie Smith, Lizzie Smith, Sunell Smith, Cassius Smith, Stefan Smuts, Ayanda Sofe, Khobane Solomon, L J Solomon, chauke Sombani, Richard Songca, Anga Sontamo, Supriya Soorju, Zubenathi Sopazi, Brian Soqasha, Bongiwe Sosibo, Ntsika Sotsaka, Mandy Soula, Simon Spoor, Sarah Stacey, Asanda Stali, Mutele Mmboniseni Stephina, Myra Steup, Sinoxolo Steven, AW Stevens, Vincent Stevens, Dewald Steyn, Bianca Steyn, Pat Stocks, Henk Stolk, Alida Stoltz, Renate Strehlau, Anneke Stroebel, Loraine Strydom, Jean-Marie Strydom, Anton Strydom, Ursula Strydom, Midhu Sunnyraj, Nwabisa Swana, Winnie Swanepoel, Suzan Swanepoel, Elsie Swartbooi, Estley Swartz Swartz, Casandra Syce, Shihambi T E, Joyce Tabane, N E Tabane, Mrs Tawana, Ntene Tebello, Siphosetu Wiseman Tembe, Samantha Terblanche, Ntombifuthi Thabede, Nkhumeleni Thabelo, Sibusiso Thabethe, Lekhanya Thabo George, Keorapetse Thare, Makofane Thebogo, Lerato Thekiso, Lloyd Theko, Celimphilo Zandi Themba, Danie Theron, Henda Theron, Ilze Theron, Thandiwe Thingathinga, M M Thlabadira, Dikeledi Thoka, Zanele Thokwana, Gustav Thom, Mamphot Joel Thubakgale, Theodora Thwala, P Thys, Monethi Tieho, Matodzi Timothy, Ndlovu Tintswalo, Babalwa Tivana, Molefi Tladi, Bongiwe Tokota, Simthandile Toni, Ariel Torres, Mande Toubkin, Marinda Tsatsi, Khanyisile Tshabalala, Nozibele Tshamase, Gontse Tshefu, Makgoga Tshegofatjo, Given Tshikomba, Thapelo Tshilo, Lerato Tshira, S T Tshirado, Maipfi Tshisikule, G Tsoke, N TSOKE, Alatha Tsoko, Mosele Tsotetsi, Sandeva Tsubella, Noxolo Tuswa, Maipato Tutse, Nomayenzeke Tutu, Sphephelo Twala, Nhlanhla Twala, Simphiwe Twala, John Ubisi, Tefo Unathi, A Van Aswegen, Marietjie van der Merwe, Trudie van der Merwe, Patience van der Plank, Elmarie van der Spuy, Linda Van Der Westhuizen, Adele Van Der Westhuizen, Talana van der Westhuizen, Mene van der Westhuyzen, Thea Van Dyk, Ingrid van Heerden, Ryno van Jaarsveld, M Van Lill, Heidi van Niekerk, Ben van Niekerk, Amanda van Rensburg, Judy van Schallwyk, Zeitschke Yarnrich Van Sensie, Magda van Vuuren, Cloete van Vuuren, Olga Funiswa Vandu, Mandisa Vane, Lucia VanZyl, Ebrahim Variava, Mariam Veerus, Nokhwezi Velapi, Sebina Veleko, Z Velezantsi, Retha Venter, Corlia Vergottini, Inga Vermeulen, Liabara Lufuluvhi Vidah, Bongani Vilakazi, Treasure N Vilakazi, Mbalenhle Precious Vilakazi, Karen Viljoen, Werner Viljoen, Zuretha Volschenk, Angelo Vos, Matlala V V, Jacques Walters, Kate Webb, John Welsh, D Wessels, Judy Wheller, Fundile White, Priscilla White, Carmen Whyte, Ansie Willemse, Sape William, Daniel Williams, Kamielah Williams, Mercia Williams, Anne Williamson, Cherade Wilson, Boipelo Wolff, Michelle Wray, Ntombizonke B Xaba, Thabang Jabulani Xaba, Thanks Xiniwe, Mtshali Xoliswa, Funokwakhe Xulu, Gibson Xulu, Sandlakazi Yam, NM Zakhura, Mashela Zareloa, Sive Zinto, Dyibeni Zinziswa, Lulamile Ziselo, Zakhele Zitha, Emmanuel Zitha, Anele Zokufa, Innocent Zondi, Sikhumbuzo Bernard Zondi, Sbuyi Zondi, Thulani Zondi, Wandiswa Zongola, Liesl Zühlke, Zandile Zulu, Lungelo Zulu, Thandeka Zulu, Slindili Zulu, Nkosinathi Zulu, Angel Zuma, Precious Zungu, Pamela Zungu, Melusi Zungu, Priscilla Zungu, Bongo Lihle Zwakala, Antonia Zwane, Promise Zwane, Muziwendoda Zwane, Hlengiwe Priscila Zwane, and Nomgcobo Zwane
Subjects: Male, Pediatrics, medicine.medical_specialty, Tuberculosis, Epidemiology, Immunology, HIV Infections, Comorbidity, Disease, Cohort Studies, South Africa, Risk Factors, Virology, Diabetes mellitus, Prevalence, Humans, Medicine, Hospital Mortality, Asthma, SARS-CoV-2, business.industry, Public health, COVID-19, Articles, Odds ratio, medicine.disease, Infectious Diseases, Anti-Retroviral Agents, Female, business, Cohort study
Abstract: Summary Background The interaction between COVID-19, non-communicable diseases, and chronic infectious diseases such as HIV and tuberculosis is unclear, particularly in low-income and middle-income countries in Africa. South Africa has a national HIV prevalence of 19% among people aged 15–49 years and a tuberculosis prevalence of 0·7% in people of all ages. Using a nationally representative hospital surveillance system in South Africa, we aimed to investigate the factors associated with in-hospital mortality among patients with COVID-19. Methods In this cohort study, we used data submitted to DATCOV, a national active hospital surveillance system for COVID-19 hospital admissions, for patients admitted to hospital with laboratory-confirmed SARS-CoV-2 infection between March 5, 2020, and March 27, 2021. Age, sex, race or ethnicity, and comorbidities (hypertension, diabetes, chronic cardiac disease, chronic pulmonary disease and asthma, chronic renal disease, malignancy in the past 5 years, HIV, and past and current tuberculosis) were considered as risk factors for COVID-19-related in-hospital mortality. COVID-19 in-hospital mortality, the main outcome, was defined as a death related to COVID-19 that occurred during the hospital stay and excluded deaths that occurred because of other causes or after discharge from hospital; therefore, only patients with a known in-hospital outcome (died or discharged alive) were included. Chained equation multiple imputation was used to account for missing data and random-effects multivariable logistic regression models were used to assess the role of HIV status and underlying comorbidities on COVID-19 in-hospital mortality. Findings Among the 219 265 individuals admitted to hospital with laboratory-confirmed SARS-CoV-2 infection and known in-hospital outcome data, 51 037 (23·3%) died. Most commonly observed comorbidities among individuals with available data were hypertension in 61 098 (37·4%) of 163 350, diabetes in 43 885 (27·4%) of 159 932, and HIV in 13 793 (9·1%) of 151 779. Tuberculosis was reported in 5282 (3·6%) of 146 381 individuals. Increasing age was the strongest predictor of COVID-19 in-hospital mortality. Other factors associated were HIV infection (adjusted odds ratio 1·34, 95% CI 1·27–1·43), past tuberculosis (1·26, 1·15–1·38), current tuberculosis (1·42, 1·22–1·64), and both past and current tuberculosis (1·48, 1·32–1·67) compared with never tuberculosis, as well as other described risk factors for COVID-19, such as male sex; non-White race; underlying hypertension, diabetes, chronic cardiac disease, chronic renal disease, and malignancy in the past 5 years; and treatment in the public health sector. After adjusting for other factors, people with HIV not on antiretroviral therapy (ART; adjusted odds ratio 1·45, 95% CI 1·22–1·72) were more likely to die in hospital than were people with HIV on ART. Among people with HIV, the prevalence of other comorbidities was 29·2% compared with 30·8% among HIV-uninfected individuals. Increasing number of comorbidities was associated with increased COVID-19 in-hospital mortality risk in both people with HIV and HIV-uninfected individuals. Interpretation Individuals identified as being at high risk of COVID-19 in-hospital mortality (older individuals and those with chronic comorbidities and people with HIV, particularly those not on ART) would benefit from COVID-19 prevention programmes such as vaccine prioritisation as well as early referral and treatment. Funding South African National Government.
Published: 2021

5. Asymmetric dimethylarginine and l-homoarginine prospectively relate to carotid wall thickness in a South African cohort

Author: Rainer H. Böger, Catharina M. C. Mels, Edzard Schwedhelm, Shani Botha-Le Roux, Carla M.T. Fourie, Maserame Cleopatra Mokhaneli, 10062491 - Fourie, Catharina Maria Theresia, 20695241 - Botha, Shani, 12076341 - Mels, Catharina Martha Cornelia, and 21275203 - Mokhaneli, Maserame Cleopatra
Subjects: Male, 0301 basic medicine, medicine.medical_specialty, Arginine, Clinical Biochemistry, Population, Black People, Blood Pressure, Nitric Oxide, Carotid Intima-Media Thickness, Biochemistry, Cohort Studies, Pathogenesis, South Africa, 03 medical and health sciences, chemistry.chemical_compound, Internal medicine, Epidemiology, medicine, Humans, Cross-sectional wall area, Prospective Studies, Carotid intima-media thickness, education, Aged, Ultrasonography, education.field_of_study, 030102 biochemistry & molecular biology, business.industry, Organic Chemistry, Nitric oxide, Middle Aged, Atherosclerosis, Homoarginine, 030104 developmental biology, chemistry, Cohort, Cardiology, Female, L-homoarginine, Wall thickness, Asymmetric dimethylarginine, business
Abstract: Background and aims The L-arginine derivatives asymmetric (ADMA) and symmetric dimethylarginine (SDMA), as well as L-homoarginine may have opposing effects in the pathogenesis of atherosclerosis. We aimed to investigate (i) 5-year changes in arginine derivatives, and (ii) the association between baseline arginine derivatives and follow-up measures of carotid wall thickness in South Africans. Methods and results This study included men (n = 187) and women (n = 396) who took part in the 2010 and 2015 data collections of the South African arm of the Prospective Urban and Rural Epidemiology (PURE) study. Arginine derivatives were determined in plasma with liquid chromatography-tandem mass spectrometry. Carotid intima-media thickness (cIMT) and cross-sectional wall area (CSWA) were determined with B-mode ultrasonography. Results Mean values of arginine derivatives did not change over time. In the study group, follow-up cIMT (β = − 0.10 p = 0.018) and CSWA (β = − 0.12; p = 0.004) inversely associated with baseline L-homoarginine, and cIMT inversely associated with ADMA (β = − 0.09; p = 0.033). In women, CSWA inversely associated with both ADMA (β = − 0.11; p = 0.034) and L-homoarginine (β = − 0.11; p = 0.024). No such associations were found in men. Conclusion These results suggest that higher levels of L-homoarginine may play a protective role against vascular injury and delay progression of carotid wall thickening in this cohort. The role of ADMA in atherosclerosis deserves further investigation in this population
Published: 2020

6. Changes in Circulating Kisspeptin Levels During Each Trimester in Women With Antenatal Complications

Author: Tom Kelsey, Rans Nadir, Alexander N Comninos, Elisabeth Daniels, Sophie A Clarke, Paul Bech, Ewa Pacuszka, Edouard Mills, Tia Hunjan, Waljit S. Dhillo, Tricia Tan, Ali Abbara, Pei Chia Eng, Lisa Yang, Maya Al-Memar, C. Kyriacou, Tom Bourne, Maria Phylactou, Chioma Izzi-Engbeaya, H. Fourie, Bijal Patel, University of St Andrews. School of Computer Science, University of St Andrews. Centre for Interdisciplinary Research in Computational Algebra, National Institute for Health Research, Medical Research Council, and Medical Research Council (MRC)
Subjects: Male, Kisspeptin, Placenta Diseases, preterm birth (PTB), QH301 Biology, Endocrinology, Diabetes and Metabolism, Clinical Biochemistry, Early pregnancy factor, Biochemistry, fetal growth restriction (FGR), Endocrinology, GESTATIONAL-AGE INFANTS, Pre-Eclampsia, Pregnancy, KISS-1, GROWTH RESTRICTION, London, hypertensive diseases of pregnancy (HDP), METASTIN, Kisspeptins, Fetal Growth Retardation, biology, Obstetrics, Gestational age, 3rd-DAS, Prognosis, Gestational diabetes, PREECLAMPSIA, PREGNANCY, intrauterine growth restriction (IUGR), RG Gynecology and obstetrics, Preterm birth (PTB), Biomarker (medicine), Premature Birth, Female, Pregnancy Trimesters, Life Sciences & Biomedicine, hormones, hormone substitutes, and hormone antagonists, AcademicSubjects/MED00250, Fetal growth restriction (FGR), Adult, medicine.medical_specialty, Context (language use), Gestational Age, Third trimester, kisspeptin, Endocrinology & Metabolism, QH301, SDG 3 - Good Health and Well-being, Internal medicine, medicine, Humans, PLACENTAL EXPRESSION, Online Only Articles, Clinical Research Articles, Science & Technology, Gestational diabetes (GDM), business.industry, Biochemistry (medical), Intrauterine growth restriction (IUGR), Infant, Newborn, 1103 Clinical Sciences, Hypertension, Pregnancy-Induced, medicine.disease, Diabetes, Gestational, gestational diabetes (GDM), Case-Control Studies, biology.protein, 1114 Paediatrics and Reproductive Medicine, FETAL-GROWTH, WEIGHT, RG, business, PLASMA KISSPEPTIN, Hypertensive diseases of pregnancy (HDP), Biomarkers, Follow-Up Studies
Abstract: Funding: This paper presents independent research supported by the National Funding: Institute for Health Research (NIHR) Clinical Research Facility and the NIHR Biomedical Research Centre based at Imperial College Healthcare NHS Trust. AA is supported by an NIHR Clinician Scientist award (CS‐2018‐18‐ST2‐002). MAM is funded by the Tommy’s National Centre for Miscarriage Research. MP is supported by an NIHR Academic Clinical Lectureship. CI-E is supported by an Imperial College-BRC IPPRF Fellowship. SAC is supported by an NIHR Academic Clinical Lectureship. EGM is supported by an MRC clinical training fellowship (MR/T006242/1). LY is supported by an MRC clinical training fellowship (MR/R000484/1). ANC is supported by the NHS and BRC. TB is supported by the NIHR Biomedical Research Centre based at Imperial College Healthcare NHS Trust. WSD is supported by an NIHR Research Professorship (RP-2014-05-001). Context: Antenatal complications such as hypertensive disorders of pregnancy (HDP), fetal growth restriction (FGR), gestational diabetes (GDM), and preterm birth (PTB) are associated with placental dysfunction. Kisspeptin has emerged as a putative marker of placental function, but limited data exist describing circulating kisspeptin levels across all three trimesters in women with antenatal complications. Objective: To assess whether kisspeptin levels are altered in women with antenatal complications. Methods: Women with antenatal complications (n = 105) and those with uncomplicated pregnancies (n = 265) underwent serial ultrasound scans and blood sampling at the Early Pregnancy Assessment Unit at Hammersmith Hospital, UK, at least once during each trimester (March 2014 to March 2017). The women with antenatal complications (HDP [n = 32], FGR [n = 17], GDM [n = 35], PTB [n = 11], and multiple complications [n=10]) provided 373 blood samples and the controls provided 930 samples. Differences in circulating kisspeptin levels were assessed. Participants: Women with antenatal complications: HDP (n=32), FGR (n=17), GDM (n=35) and PTB (n=11), and 10 women with multiple complications, provided 373 blood samples, and a further 265 controls provided 930 samples. Results: Third-trimester kisspeptin levels were higher than controls in HDP but lower in FGR. The odds of HDP adjusted for gestational age, maternal age, ethnicity, BMI, smoking, and parity were increased by 30% (95% CI, 16%-47%; P
Published: 2021

7. Moxifloxacin Pharmacokinetics, Cardiac Safety, and Dosing for the Treatment of Rifampicin-Resistant Tuberculosis in Children

Author: Anneke C. Hesseling, Barend Fourie, Jana Winckler, H. Simon Schaaf, Anthony J Garcia-Prats, James C. Nielsen, Belén P. Solans, Stephanie Thee, Lubbe Wiesner, Louvina E van der Laan, Radojka M. Savic, Heather R. Draper, and Kendra K. Radtke
Subjects: Adult, Microbiology (medical), Drug, medicine.medical_specialty, Tuberculosis, media_common.quotation_subject, Moxifloxacin, HIV Infections, QT interval, Clofazimine, Electrocardiography, Pharmacokinetics, Internal medicine, Tuberculosis, Multidrug-Resistant, Humans, Medicine, Dosing, Child, media_common, business.industry, medicine.disease, NONMEM, Major Articles and Commentaries, Infectious Diseases, Child, Preschool, Rifampin, business, Fluoroquinolones, medicine.drug
Abstract: Background Moxifloxacin is a recommended drug for rifampin-resistant tuberculosis (RR-TB) treatment, but there is limited pediatric pharmacokinetic and safety data, especially in young children. We characterize moxifloxacin population pharmacokinetics and QT interval prolongation and evaluate optimal dosing in children with RR-TB. Methods Pharmacokinetic data were pooled from 2 observational studies in South African children with RR-TB routinely treated with oral moxifloxacin once daily. The population pharmacokinetics and Fridericia-corrected QT (QTcF)-interval prolongation were characterized in NONMEM. Pharmacokinetic simulations were performed to predict expected exposure and optimal weight-banded dosing. Results Eighty-five children contributed pharmacokinetic data (median [range] age of 4.6 [0.8–15] years); 16 (19%) were aged Conclusions Moxifloxacin doses above 10–15 mg/kg are likely required in young children to match adult exposures but require further safety assessment, especially when coadministered with other QT-prolonging agents.
Published: 2021

8. Risk factors for, and molecular epidemiology and clinical outcomes of, carbapenem‐ and polymyxin‐resistant Gram‐negative bacterial infections in pregnant women, infants, and toddlers: a systematic review and meta‐analyses

Author: P.B. Fourie, John Osei Sekyere, and Melese Abate Reta
Subjects: Adult, Carbapenem, medicine.medical_specialty, Adolescent, medicine.drug_class, Polymyxin, Antibiotics, Risk Assessment, General Biochemistry, Genetics and Molecular Biology, Young Adult, Antibiotic resistance, History and Philosophy of Science, Pregnancy, Risk Factors, Drug Resistance, Multiple, Bacterial, Internal medicine, medicine, Humans, Infection control, Polymyxins, Mortality, Pregnancy Complications, Infectious, Molecular Epidemiology, biology, business.industry, General Neuroscience, Infant, Newborn, Infant, Middle Aged, biology.organism_classification, Anti-Bacterial Agents, Acinetobacter baumannii, Low birth weight, Carbapenems, Child, Preschool, Colistin, Female, medicine.symptom, Gram-Negative Bacterial Infections, business, medicine.drug
Abstract: In the following systematic review and meta-analyses, we report several conclusions about resistance to carbapenem and polymyxin last-resort antibiotics for treating multidrug-resistant bacterial infections among pregnant women and infants. Resistance to carbapenems and polymyxins is increasing, even in otherwise vulnerable groups such as pregnant women, toddlers, and infants, for whom therapeutic options are limited. In almost all countries, carbapenem-/polymyxin-resistant Klebsiella pneumoniae, Escherichia coli, and Acinetobacter baumannii infect and/or colonize neonates and pregnant women, causing periodic outbreaks with very high infant mortalities. Downregulation of plasmid-borne blaNDM , blaKPC , blaOXA-48 , blaIMP, blaVIM , blaGES-5 , and ompK35/36 in clonal strains accelerates the horizontal and vertical transmissions of carbapenem resistance among these pathogens. New Delhi metallo-β-lactamase (NDM)-positive isolates in infants/neonates have been mainly detected in China and India, while OXA-48-positive isolates in infants/neonates have been mainly detected in Africa. NDM-positive isolates in pregnant women have been found only in Madagascar. Antibiotic therapy, prolonged hospitalization, invasive procedures, mechanical ventilation, low birth weight, and preterm delivery have been common risk factors associated with carbapenem/polymyxin resistance. The use of polymyxins to treat carbapenem-resistant infections may be selecting for resistance to both agents, restricting therapeutic options for infected infants and pregnant women. Currently, low- and middle-income countries have the highest burden of these pathogens. Antibiotic stewardship, periodic rectal and vaginal screening, and strict infection control practices in neonatal ICUs are necessary to forestall future outbreaks and deaths.
Published: 2021

9. Homoarginine and blood pressure: a 10-year prospective relationship in normotensives

Author: Maserame Cleopatra Mokhaneli, Rainer H. Böger, Catharina M. C. Mels, Carla M.T. Fourie, Shani Botha-Le Roux, and Edzard Schwedhelm
Subjects: medicine.medical_specialty, Nitric oxide synthesis, business.industry, 030204 cardiovascular system & hematology, Pulse pressure, Nitric oxide, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Endocrinology, Blood pressure, chemistry, Internal medicine, Internal Medicine, Medicine, 030212 general & internal medicine, business
Abstract: Nitric oxide plays a major role in the regulation of blood pressure, and impaired nitric oxide bioavailability contributes to the development of hypertension (HT). Various factors may contribute to nitric oxide bioavailability-including availability of the substrate for nitric oxide synthesis, L-arginine and its homolog L-homoarginine. We investigated whether blood pressure after 10 years associates with baseline L-homoarginine in participants who remained normotensive (NT) or developed HT, respectively. Data from the South African leg of the Prospective Urban and Rural Epidemiology study, performed in the North-West Province, were used. We investigated participants who either remained NT (N = 166) or who developed HT (N = 166) over 10 years. Blood pressure was measured with validated OMRON devices and serum L-homoarginine was analyzed with liquid chromatography-tandem mass spectrometry. L-homoarginine levels were similar at baseline (p = 0.39) and follow-up (p = 0.93) between NT and hypertensive groups. In the group that remained NT after 10 years, baseline L-homoarginine correlated positively with follow-up brachial systolic blood pressure (adj.R2 = 0.13; β = 0.33; p = 0.001), brachial pulse pressure (adj.R2 = 0.15 β = 0.40; p = 0.001), and central pulse pressure (adj.R2 = 0.20; β = 0.30; p = 0.003). No significant associations were found in the group that developed HT after 10 years. We found a positive, independent association between blood pressure and L-homoarginine in a group that remained NT, but not in a group that developed HT after 10 years. This may suggest a protective role for L-homoarginine to maintain normal blood pressure, but only to a certain level. Once HT develops other factors may overshadow the protective effects of L-homoarginine.
Published: 2021

10. Silicone adhesive multilayer foam dressings as adjuvant prophylactic therapy to prevent hospital‐acquired pressure ulcers: a pragmatic noncommercial multicentre randomized open‐label parallel‐group medical device trial*

Author: F. Hulstaert, H. Keymeulen, I. Savoye, Charlotte Raepsaet, F. Vrijens, J. Van De Woestijne, L. Verhaeghe, N. Vandergheynst, A. de Graaf, Dimitri Beeckman, Joe Harrison, B. Hendrickx, Katrien Vanderwee, Liesbet Demarré, Dorien De Meyer, Anika Fourie, V. Hanssens, Sofie Verhaeghe, A. Van Hecke, Steven Smet, Hilde Beele, N. Van Damme, Bénédicte Manderlier, and R. Vossaert
Subjects: Adult, medicine.medical_specialty, Heel, CLINICAL EFFECTIVENESS, Population, Silicones, Dermatology, 030207 dermatology & venereal diseases, 03 medical and health sciences, 0302 clinical medicine, Adhesives, Medicine and Health Sciences, Adjuvant therapy, medicine, Clinical endpoint, Humans, education, Pressure Ulcer, education.field_of_study, business.industry, Incidence (epidemiology), Bandages, Hospitals, Confidence interval, Surgery, Silicone foam, medicine.anatomical_structure, Relative risk, business
Abstract: Background Silicone adhesive multilayer foam dressings are used as adjuvant therapy to prevent hospital-acquired pressure ulcers (PUs). Objectives To determine whether silicone foam dressings in addition to standard prevention reduce the incidence of PUs of category 2 or worse compared with standard prevention alone. Methods This was a multicentre, randomized controlled medical device trial conducted in eight Belgian hospitals. At-risk adult patients were centrally randomized (n = 1633) to study groups based on a 1 : 1 : 1 allocation: experimental groups 1 (n = 542) and 2 (n = 545) - pooled as the treatment group - and the control group (n = 546). The experimental groups received PU prevention according to hospital protocol, and a silicone foam dressing on the relevant body sites. The control group received standard of care. The primary endpoint was the incidence of a new PU of category 2 or worse at the studied body sites. Results In the intention-to-treat population (n = 1605), PUs of category 2 or worse occurred in 4·0% of patients in the treatment group and 6·3% in the control group [relative risk (RR) 0·64, 95% confidence interval (CI) 0·41-0·99, P = 0·04]. Sacral PUs were observed in 2·8% and 4·8% of the patients in the treatment group and the control group, respectively (RR 0·59, 95% CI 0·35-0·98, P = 0·04). Heel PUs occurred in 1·4% and 1·9% of patients in the treatment and control groups, respectively (RR 0·76, 95% CI 0·34-1·68, P = 0·49). Conclusions Silicone foam dressings reduce the incidence of PUs of category 2 or worse in hospitalized at-risk patients when used in addition to standard of care. The results show a decrease for the sacrum, but no statistical difference for the heel and trochanter areas.
Published: 2020

11. Vascular function and cardiovascular risk in a HIV infected and HIV free cohort of African ancestry: baseline profile, rationale and methods of the longitudinal EndoAfrica-NWU study

Author: Jitcy S Joseph, Aletta E. Schutte, Carina Mels, Adele Burger, Shani Botha-Le Roux, Hans Strijdom, Nandu Goswami, Carla M.T. Fourie, Yolandi Breet, Lisa Uys, Lebo F. Gafane-Matemane, Leandi Lammertyn, Patrick De Boever, Wayne Smith, Schutte, Aletta E/0000-0001-9217-4937, Fourie, Carla, MT/0000-0003-1950-1553, Strijdom, Hans/0000-0003-3726-9153, De Boever, Patrick/0000-0002-5197-8215, Fourie, Carla M. T., Botha-Le Roux, Shani, Smith, Wayne, Schutte, Aletta E., Breet, Yolandi, Mels, Carina M. C., Gafane-Matemane, Lebo F., Lammertyn, Leandi, Uys, Lisa, Burger, Adele, Joseph, Jitcy S., Goswami, Nandu, DE BOEVER, Patrick, and Strijdom, Hans
Subjects: Male, Blood Pressure, Disease, 030204 cardiovascular system & hematology, chemistry.chemical_compound, South Africa, 0302 clinical medicine, Medical microbiology, High-density lipoprotein, Risk Factors, 030212 general & internal medicine, Longitudinal Studies, Endothelial dysfunction, Pulse wave velocity, Middle Aged, Cardiovascular risk markers, Antiretroviral therapy, Infectious Diseases, Anti-Retroviral Agents, African ancestry, Cardiovascular Diseases, Cohort, Female, Research Article, Adult, medicine.medical_specialty, Pulse Wave Analysis, lcsh:Infectious and parasitic diseases, 03 medical and health sciences, Internal medicine, medicine, Humans, lcsh:RC109-216, Noncommunicable Diseases, Triglycerides, Glycated Hemoglobin, Acquired Immunodeficiency Syndrome, business.industry, Cholesterol, HDL, HIV, Endothelial function, Vascular function, medicine.disease, Blood pressure, Cross-Sectional Studies, chemistry, Case-Control Studies, Human medicine, business, Body mass index, Biomarkers
Abstract: Background People living with the Human Immunodeficiency Virus (PLHIV) have an increased susceptibility to develop non-communicable diseases such as cardiovascular disease (CVD). Infection with HIV contributes to the development of CVD independent of traditional risk factors, with endothelial dysfunction being the central physiological mechanism. While HIV-related mortality is declining due to antiretroviral treatment (ART), the number of deaths due to CVD is rising in South Africa - the country with the highest number of PLHIV and the world's largest ART programme. The EndoAfrica study was developed to determine whether HIV infection and ART are associated with cardiovascular risk markers and changes in vascular structure and function over 18 months in adults from different provinces of South Africa. This paper describes the rationale, methodology and baseline cohort profile of the EndoAfrica study conducted in the North West Province, South Africa. Methods In this case-control study, conducted between August 2017 and June 2018, 382 volunteers of African descent (276 women; 106 men), comprising of 278 HIV infected and 104 HIV free individuals were included. We measured health behaviours, a detailed cardiovascular profile, and performed biomarker analyses. We compared baseline characteristics, blood pressure, vascular function and biochemical markers between those infected and HIV free. Results At baseline, the HIV infected participants were older (43 vs 39 years), less were employed (21% vs 40%), less had a tertiary education (7% vs 16%) and their body mass index was lower (26 vs 29 kg/m(2)) than that of the HIV free participants. While the cardiovascular profile, flow-mediated dilation and pulse wave velocity did not differ, glycated haemoglobin was lower (p = 0.017) and total cholesterol, high density lipoprotein cholesterol, triglycerides, gamma-glutamyltransferase and tobacco use were higher (allp < 0.047) in PLHIV. Conclusion Despite PLHIV being older, preliminary cross-sectional analysis suggests that PLHIV being treated with ART do not have poorer endothelial or vascular function compared to the HIV free participants. More detailed analyses on the baseline and follow-up data will provide further clarity regarding the cardiovascular profile of South Africans living with HIV. The EndoAfrica-NWU study formed part of a broader consortium under the ERAfrica program of the European Union 7th Framework Program. Funding is disbursed via the Department of Science and Innovation in South Africa (contract number DST/CON 0077/2014). AES is funded by the South African National Research Foundation (SARChI GUN 86895) and South African Medical Research Council. PDB and NG received funding from the Belgian Science Policy in Belgium (Grant number BL/67/eranet03), and the Osterreichische Agentur fur internationale Mobilitat und Kooperation in Bildung, Wissenschaft und Forschung, OeAD GmbH (OAD) in Austria (Grant number: KEF-Projekt P202). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Fourie, CMT (corresponding author), North West Univ, Hypertens Africa Res Team HART, Private Bag X1290, Potchefstroom, South Africa; North West Univ, Fac Hlth Sci, South African Med Res Council, Unit Hypertens & Cardiovasc Dis, Potchefstroom, South Africa. carla.fourie@nwu.ac.za
Published: 2020

12. FDA Approval Summary: Selpercatinib for the Treatment of Lung and Thyroid Cancers with RET Gene Mutations or Fusions

Author: Julia A. Beaver, Whitney S. Helms, Harpreet Singh, Jiang Liu, Reena Philip, Diana Bradford, Dun Liang, Francisca Reyes Turcu, Amy M. Skinner, Rosane Charlab, Shenghui Tang, Soma Ghosh, Lauren S. L. Price, Marc R. Theoret, Richard Pazdur, Erin Larkins, Donna Roscoe, Yangbing Li, Jeanne Fourie Zirkelbach, Sirisha Mushti, Autumn Zack-Taylor, Lisa Rodriguez, and Paul G. Kluetz
Subjects: 0301 basic medicine, Oncology, Cancer Research, medicine.medical_specialty, Lung, endocrine system diseases, business.industry, Thyroid, Medullary thyroid cancer, medicine.disease, QT interval, Systemic therapy, Clinical trial, 03 medical and health sciences, 030104 developmental biology, 0302 clinical medicine, medicine.anatomical_structure, 030220 oncology & carcinogenesis, Internal medicine, Toxicity, medicine, business, Thyroid cancer
Abstract: On May 8, 2020, the FDA granted accelerated approval to selpercatinib for (i) adult patients with metastatic RET fusion–positive non–small cell lung cancer (NSCLC), (ii) adult and pediatric patients ≥12 years of age with advanced or metastatic RET-mutant medullary thyroid cancer who require systemic therapy, and (iii) adult and pediatric patients ≥12 years of age with advanced or metastatic RET fusion–positive thyroid cancer who require systemic therapy and who are radioactive iodine refractory (if radioactive iodine is appropriate). Approval was granted on the basis of the clinically important effects on the overall response rate (ORR) with prolonged duration of responses observed in a multicenter, open-label, multicohort clinical trial (LIBRETTO-001, NCT03157128) in patients whose tumors had RET alterations. ORRs within the approved patient populations ranged from 64% [95% confidence interval (CI), 54–73] in prior platinum-treated RET fusion–positive NSCLC to 100% (95% CI, 63–100) in systemic therapy–naïve RET fusion–positive thyroid cancer, with the majority of responders across indications demonstrating responses of at least 6 months. The product label includes warnings and precautions for hepatotoxicity, hypertension, QT interval prolongation, hemorrhagic events, hypersensitivity, risk of impaired wound healing, and embryo-fetal toxicity. This is the first approval of a drug specifically for patients with RET alterations globally.
Published: 2020

13. Natural history of pregnancy‐related enhanced myometrial vascularity following miscarriage

Author: Catriona Stalder, Maya Al-Memar, K. Grewal, D. Timmerman, H. Fourie, and Tom Bourne
Subjects: Blood transfusion, medicine.medical_treatment, arteriovenous malformation, Miscarriage, 0302 clinical medicine, Arteriovenous malformations, Pregnancy, London, Prospective Studies, 030212 general & internal medicine, Embolization, Ultrasonography, Doppler, Color, Prospective cohort study, Ultrasonography, 030219 obstetrics & reproductive medicine, Neovascularization, Pathologic, Radiological and Ultrasound Technology, Incidence, Incidence (epidemiology), Doppler, Obstetrics and Gynecology, ultrasonography, General Medicine, enhanced myometrial vascularity, Products of conception, Cohort, Myometrium, Female, color Doppler, Adult, medicine.medical_specialty, Color, Ultrasonography, Prenatal, 03 medical and health sciences, medicine, Humans, Radiology, Nuclear Medicine and imaging, Watchful Waiting, Obstetrics & Reproductive Medicine, spontaneous miscarriage, business.industry, Spontaneous, Abortion, medicine.disease, Surgery, Abortion, Spontaneous, Pregnancy Trimester, First, Reproductive Medicine, 1114 Paediatrics and Reproductive Medicine, Enhanced myometrial vascularity, business, Placenta, Retained
Abstract: OBJECTIVES: Our primary aim was to report the incidence of enhanced myometrial vascularity (EMV) in consecutive women attending our early pregnancy assessment unit, following first-trimester miscarriage. We aimed further to evaluate the clinical presentation and complications associated with expectant and surgical management of EMV in these women. METHODS: This was a prospective cohort study conducted in a London teaching hospital between June 2015 and June 2018, including consecutive patients with an observation of EMV on transvaginal ultrasonography following first-trimester miscarriage. The diagnosis was made following the subjective identification of EMV using color Doppler ultrasonography and a peak systolic velocity (PSV) ≥ 20 cm/s within the collection of vessels. Women were followed up with repeat scans every 14 days. Management was expectant unless intervention was indicated because of excessive or prolonged bleeding, persistent presence of retained tissue in the endometrial cavity or patient choice. The final clinical outcome was recorded. Time to resolution of EMV was defined as the interval from detection of EMV until resolution. RESULTS: During the study period, there were 2627 first-trimester fetal losses in the department and, of these, 40 patients were diagnosed with EMV, hence the incidence of EMV following miscarriage was 1.52%. All cases were associated with ultrasound evidence of retained products of conception (RPOC) at presentation (mean dimensions, 22 × 20 × 20 mm). Thirty-one patients opted initially for expectant management, of which 18 had successful resolution without intervention, five were lost to follow-up and eight subsequently had surgical evacuation due to patient choice. No expectantly managed case required emergency intervention. Nine patients chose surgical evacuation as primary treatment. No significant correlation was seen between PSV within the EMV at presentation and blood loss at surgery. Median PSV was 47 (range, 20-148) cm/s. The estimated blood loss in all cases managed surgically ranged from 20-300 mL. Presence of RPOC was confirmed in all specimens that were sent for analysis following surgery. For cases successfully managed expectantly, the mean time to resolution was 48 (range, 21-84) days. In the nine cases managed surgically from the beginning, the mean time to resolution of EMV was 10.6 (range, 3-29) days. CONCLUSIONS: This study suggests that EMV is an uncommon finding following miscarriage and is associated with the presence of RPOC. Expectant management was a safe option in our cohort, with minimal bleeding, although it was associated with protracted time to resolution. In patients who opted for surgery, the maximum blood loss was 300 mL and no patient required blood transfusion or embolization. Copyright © 2019 ISUOG. Published by John Wiley & Sons Ltd. ispartof: ULTRASOUND IN OBSTETRICS & GYNECOLOGY vol:55 issue:5 pages:676-682 ispartof: location:England status: published
Published: 2020

14. First‐trimester intrauterine hematoma and pregnancy complications

Author: Srdjan Saso, H. Fourie, Shabnam Bobdiwala, T. Vaulet, Timothy Bracewell-Milnes, D. Timmerman, S. Sur, J. Farren, Catriona Stalder, Phillip R. Bennett, Maya Al-Memar, B. De Moor, and Tom Bourne
Subjects: Adult, medicine.medical_specialty, adverse pregnancy outcomes, miscarriage, Gestational sac, Pelvic Pain, Ultrasonography, Prenatal, Miscarriage, Pregnancy, London, medicine, Humans, Radiology, Nuclear Medicine and imaging, Vaginal bleeding, Prospective Studies, Hematoma, Radiological and Ultrasound Technology, Obstetrics, business.industry, Incidence, Pelvic pain, preterm birth, Obstetrics and Gynecology, General Medicine, Odds ratio, medicine.disease, Abortion, Spontaneous, Pregnancy Complications, Pregnancy Trimester, First, Logistic Models, medicine.anatomical_structure, Reproductive Medicine, Premature Birth, Gestation, Female, Uterine Hemorrhage, medicine.symptom, business, first trimester, intrauterine haematoma, Cohort study
Abstract: OBJECTIVE: To assess whether sonographic diagnosis of intrauterine hematoma (IUH) in the first trimester of pregnancy is associated with first-trimester miscarriage and antenatal, delivery and neonatal complications. METHODS: This was a prospective observational cohort study of women with an intrauterine singleton pregnancy between 5 and 14 weeks' gestation recruited at Queen Charlotte's and Chelsea Hospital, London, UK, between March 2014 and March 2016. Participants underwent serial ultrasound examinations in the first trimester, and the presence, location, size and persistence of any IUH was evaluated. First-trimester miscarriage was defined as pregnancy loss before 14 weeks' gestation. Clinical symptoms, including pelvic pain and vaginal bleeding, were recorded at each visit using validated symptom scores. Antenatal, delivery and neonatal outcomes were obtained from hospital records. Logistic regression analysis and the chi-square test were used to assess the association between the presence and features of IUH and the incidence of adverse pregnancy outcome. Odds ratios (OR) were first adjusted for maternal age (aOR) and then further adjusted for the presence of vaginal bleeding or pelvic pain in the first trimester. RESULTS: Of 1003 women recruited to the study, 946 were included in the final analysis and of these, 268 (28.3%) were diagnosed with an IUH in the first trimester. The presence of IUH was associated with the incidence of preterm birth (aOR, 1.94 (95% CI, 1.07-3.52)), but no other individual or overall antenatal, delivery or neonatal complications. No association was found between the presence of IUH in the first trimester and first-trimester miscarriage (aOR, 0.81 (95% CI, 0.44-1.50)). These findings were independent of the absolute size of the hematoma and the presence of vaginal bleeding or pelvic pain in the first trimester. When IUH was present in the first trimester, there was no association between its size, content or position in relation to the gestational sac and overall antenatal, delivery and neonatal complications. Diagnosis of a retroplacental IUH was associated with an increased risk of overall antenatal complications (P = 0.04). CONCLUSIONS: Our findings demonstrate that there is no association between the presence of IUH in the first trimester and first-trimester miscarriage. However, an association with preterm birth, independently of the presence of symptoms of pelvic pain and/or vaginal bleeding, is evident. Women diagnosed with IUH in the first trimester should be counseled about their increased risk of preterm birth and possibly be offered increased surveillance during the course of their pregnancy. Copyright © 2019 ISUOG. Published by John Wiley & Sons Ltd. ispartof: ULTRASOUND IN OBSTETRICS & GYNECOLOGY vol:55 issue:4 pages:536-545 ispartof: location:England status: published
Published: 2020

15. Unerwartete postoperative Diagnose eines Nebenschilddrüsenkarzinoms

Author: Stefan Fischli, Lana Fourie, Martin Litzel, and Christoph Henzen
Subjects: medicine.medical_specialty, business.industry, General Medicine, medicine.disease, Malignancy, 03 medical and health sciences, 0302 clinical medicine, medicine.anatomical_structure, Parathyroid carcinoma, 030220 oncology & carcinogenesis, medicine, Endocrine system, 030211 gastroenterology & hepatology, Parathyroid gland, Radiology, Parathyroid disease, business, Pathological, hormones, hormone substitutes, and hormone antagonists, Primary hyperparathyroidism, Parathyroid adenoma
Abstract: Unexpected Postoperative Diagnosis of Parathyroid Carcinoma Abstract. Parathyroid carcinoma is a rare endocrine malignancy. It typically presents itself with similar clinical features as seen in patients with primary hyperparathyroidism caused by a parathyroid adenoma. Due to overlapping clinical manifestations, imaging findings and pathological characteristics, the differentiation between benign and malignant parathyroid disease poses a diagnostic challenge, especially prior to surgery. We report the case of a 67-year-old male who presented with symptomatic hypercalcemia and primary hyperparathyroidism. During resection of the enlarged parathyroid gland, suspicious macroscopic features were noticed and the histopathology finding confirmed the malignancy. Parathyroid carcinoma is rarely diagnosed preoperatively, which is mainly due to the lack of distinctive symptoms or morphological features suggesting a malignant disease. As parathyroid carcinoma often has a genetic background, knowledge of mutation status and family history is of high relevance. Surgery with complete resection of the parathyroid carcinoma is the mainstay for a successful treatment and a good prognosis.
Published: 2020

16. Clinical utility of 2-D anatomic measurements in predicting cough-associated headache in Chiari I malformation

Author: Alexander Brook, Yu-Ming Chang, Chi Wen C. Huang, Rafeeque A. Bhadelia, and A. Fourie Bezuidenhout
Subjects: Adult, Male, medicine.medical_specialty, Neurology, endocrine system diseases, Contrast Media, Sensitivity and Specificity, 030218 nuclear medicine & medical imaging, 03 medical and health sciences, 0302 clinical medicine, Clivus, Chiari I malformation, Interquartile range, Image Interpretation, Computer-Assisted, Humans, Medicine, Radiology, Nuclear Medicine and imaging, Encephalocele, Retrospective Studies, Neuroradiology, Receiver operating characteristic, business.industry, Headache, Magnetic Resonance Imaging, Sagittal plane, Arnold-Chiari Malformation, medicine.anatomical_structure, Cough, Female, Neurology (clinical), Radiology, Neurosurgery, Cardiology and Cardiovascular Medicine, business, 030217 neurology & neurosurgery
Abstract: Cough-associated headache (CAH) is the most distinctive symptom of patients with Chiari I malformation (CMI) and indicates clinically significant disease. We determined the clinical utility of simple 2D anatomic measurements performed on a PACS workstation by assessing their diagnostic accuracy in predicting CAH in CMI patients. Seventy-two consecutive CMI patients (cerebellar tonsillar herniation > 5 mm) with headache seen by neurosurgeons over 6 years were included. Sagittal T1 images were used by two readers to measure: extent of tonsillar herniation, lengths of the clivus and supra-occiput, McRae and pB-C2 lines, as well as clivus-canal, odontoid retroversion, and skull base angles. Neurosurgery notes were reviewed to determine presence of CAH. Mann-Whitney test was used to compare measurements between patients with and without CAH. Predictive accuracy was assessed by receiver operating characteristic (ROC) curve. 47/72 (65.3%) CMI patients reported CAH. Tonsillar herniation with CAH (10.2 mm, 7–14 mm; median, interquartile range) was significantly greater than those without CAH (7.9 mm, 6.3–10.9 mm; p = 0.02). Tonsillar herniation ≥ 10 mm showed sensitivity and specificity of 51% and 68%, and tonsillar herniation > 14 mm showed sensitivity and specificity of 30% and 100%, respectively, for predicting CAH. Other 2D measurements showed no statistically significant differences. Among the 2D measurements used, only the extent of tonsillar herniation is different between CMI patients with and without CAH. Although CMI is diagnosed with tonsillar herniation of only 5 mm, we found that a much higher extent of herniation is needed to be predictive of CAH.
Published: 2020

17. World Association for the Advancement of Veterinary Parasitology (WAAVP) second edition: guideline for evaluating the efficacy of parasiticides against ectoparasites of ruminants

Author: Rose Peter, Josephus J. Fourie, Jozef Vercruysse, Peter Holdsworth, Nicholas N. Jonsson, and Steffen Rehbein
Subjects: Record keeping, Insecticides, medicine.medical_specialty, Veterinary parasitology, Antiparasitic Agents, Miticide, General Veterinary, Ectoparasiticide, Ectoparasite, Persistent efficacy, ACARICIDES, Ruminants, General Medicine, Guideline, Biology, Therapeutic efficacy, Acaricide, medicine, Animals, Parasitology, Medical physics, Veterinary Sciences, Insecticide
Abstract: This second edition guideline was prepared to assist in the planning, conduct and interpretation of studies to assess the efficacy of parasiticides against ectoparasites of ruminants. It provides updated information on the selection of animals, dosage determination, dosage confirmation and field studies, record keeping and result interpretation. This guideline is intended to assist investigators on how to conduct specific studies, to provide specific information for registration authorities involved in the decision-making process, to assist in the approval and registration of new ectoparasiticides, and to facilitate the worldwide adoption of standard procedures.
Published: 2022

18. Challenges in the management of life-threatening complications caused by a rare case of sarcoid-lymphoma syndrome

Author: Jürg Metzger, Irin Zschokke, Lana Fourie, and Stephanie Taha-Mehlitz
Subjects: Gastrointestinal bleeding, medicine.medical_specialty, business.industry, Fistula, Gastroenterology, Sigmoid colon, Hepatology, medicine.disease, Lymphoma, Whipple Procedure, 03 medical and health sciences, 0302 clinical medicine, medicine.anatomical_structure, 030220 oncology & carcinogenesis, Internal medicine, medicine, 030211 gastroenterology & hepatology, Radiology, Sarcoidosis, Upper gastrointestinal bleeding, business
Abstract: The sarcoid-lymphoma syndrome is a rare condition where both entities co-exist in the same patient. Overlapping clinical manifestations, imaging findings, and pathological characteristics pose both a diagnostic as well as therapeutic challenge, especially in the setting of life-threatening complications. The objective of this case report is to highlight rare complications caused by abdominal sarcoidosis as well as a subsequently diagnosed non-Hodgkin lymphoma. A 35-year-old man presented with massive upper gastrointestinal bleeding caused by a large retroperitoneal mass. Following several endoscopic and radiologic interventions, successful hemostasis could only be achieved by an emergency Whipple procedure. Biopsies of the mass showed an abdominal manifestation of sarcoidosis and corticosteroid therapy was started. The patient required several additional emergency surgeries due to a complicated bronchoperitoneal fistula, splenic abscess, perforation of the sigmoid colon, small bowel leakage, and repetitive intra-abdominal bleeding. Histopathological findings finally revealed a concurrent lymphoma, as clinically suspected earlier. Ultimately, polychemotherapy was administered. A concurrent lymphoma can lead to emergency surgery and should be considered when sarcoidosis treatment does not improve symptoms, lymphadenopathy occurs, or hematologic changes persist under therapy.
Published: 2019

19. Sarcoptes-World Molecular Network (Sarcoptes-WMN) : integrating research on scabies

Author: Abyad, A, Almeida, A, Nisbet, A, Dzamic, Am, Regassa, A, Oleaga, A, Raza, A, Terashima, A, MOLINAR MIN, Annarita, Baca, As, Alicante, Aa, Upton, A, Basu, Ak, Cho, Bk, Haj, Bs, Charaf, Bs, Bernard, B, Lassen, B, Soulsbury, C, Gortazar, C, Raccurt, C, Carlo, C, Lacroix, C, Hinzoumbé, Ck, Burkhart, Cg, Cazorla, D, Zele, D, Vincent, D, Soglia, Dominga, Acatrinei, Dc, Gotuzzo, E, Omudu, E, Papadopoulos, E, Zbikowska, E, Swai, E, Serrano, E, Mwase, E, Molin, E, Bedel, Ej, Hountondji, F, Chaudhry, Fr, Al Braikan, F, Gakuya, F, Efremova, G, Molavi, G, Vengust, G, Yang, G, Arshad, H, Babiker, H, Jianlin, H, van der Heijden, H, Zoubir, H, Mohammed, Ha, Munang'Andu, Hm, Ninomiya, H, Owen, I, Soulama, I, Lusat, J, Wilson, J, Gasca, Jm, Enrique Granado, J, Fourie, Jj, Trejos Suárez, J, Rai, K, George, K, Selim Anwar, K, Hameed, K, Khallaanyoune, K, Mumcuoglu, Ky, Solarz, K, Pei, Kj, Mandicó, Lr, Mircea, L, Fourie, L, de Moura Ariza, L, Tongué, Lk, Miron, L, Towersey, L, Löwenstein, M, Rossi, Luca, Rosalino, Lm, Rambozzi, Luisa, Alexander, M, Saridomichelakis, M, Abu Madi, M, Lareschi, M, Asman, M, Heinonen, M, Ahmad, M, Baldi, M, Strong, M, Sarasa, M, François, Mj, Mbengue, M, Ali Alhag, M, Gebely, Ma, Hamid, Me, Gharbi, M, Halami, My, Hernández, N, Gondje, Nn, Morozova, Ov, Calderón Arguedas, O, Hamarsheh, O, Aldemir, Os, Banos, Pd, Sacchi, Paola, Morrondo, P, Cuber, P, Collins, R, Kumar, R, Laha, R, Soriguer, Rc, Sani, Ra, Pinckney, R, Orusa, R, Maude, R, Rasero, Roberto, Hay, R, Rosario Cruz, R, Schuster, Rk, Rahbari, S, Ba Angood SA, Amer, S, Al Nahhas, S, Alasaad, S, Boussaa, S, Uade, S, Maione, Sandra, Kumar, S, Lavín, S, Yadav, Sc, Fitzgerald, S, Galván, Sv, Bornstein, S, Walton, S, Naz, S, Tatyana, S, Raharimanana, S, Pasca, S, Sartore, Stefano, Rehbein, S, Harris, S, Joshi, Sk, Karim, Sa, Stetanovska, T, Douri, T, Geurden, T, Leslie, T, Yanai, T, Inceboz, T, Hengge, U, Sabaj, V, Spalenza, Veronica, Al Kandari, W, Rivera, Wl, Zhu, Xq, de Armas Rodríguez, Y, Coulibaly, Yi, Mya, Yy, Lopatina, Yv, Ismail, Zb, and Zimmermann, W.
Subjects: Microbiology (medical), medicine.medical_specialty, Veterinary medicine, Knowledge management, Sarcoptes, International Cooperation, Control policy, Network, Global Health, Diagnostic methods, Community Networks, Scabies, Multidisciplinary approach, Sarcoptes world epidemiology, Epidemiology, medicine, Animals, Humans, Molecular Biology, Veterinària, Molecular systematics, Mite Infestations, Animal health, biology, business.industry, Research, Parasite Control, General Medicine, biology.organism_classification, medicine.disease, Treatment, Molecular network, Infectious Diseases, Population Surveillance, Pest Control, Sarcoptes scabiei, business
Abstract: Parasites threaten human and animal health globally. It is estimated that more than 60% of people on planet Earth carry at least one parasite, many of them several different species. Unfortunately, parasite studies suffer from duplications and inconsistencies between different investigator groups. Hence, groups need to collaborate in an integrated manner in areas including parasite control, improved therapy strategies, diagnostic and surveillance tools, and public awareness. Parasite studies will be better served if there is coordinated management of field data and samples across multidisciplinary approach plans, among academic and non-academic organizations worldwide. In this paper we report the first 'Living organism-World Molecular Network', with the cooperation of 167 parasitologists from 88 countries on all continents. This integrative approach, the 'Sarcoptes-World Molecular Network', seeks to harmonize Sarcoptes epidemiology, diagnosis, treatment, and molecular studies from all over the world, with the aim of decreasing mite infestations in humans and animals. © 2011 International Society for Infectious Diseases.
Published: 2021

20. PROTEA, A Southern African Multicenter Congenital Heart Disease Registry and Biorepository: Rationale, Design, and Initial Results

Author: Thomas Aldersley, John Lawrenson, Paul Human, Gasnat Shaboodien, Blanche Cupido, George Comitis, Rik De Decker, Barend Fourie, Lenise Swanson, Alexia Joachim, Phaphama Magadla, Malebogo Ngoepe, Liam Swanson, Alistair Revell, Raj Ramesar, Andre Brooks, Nicole Saacks, Bianca De Koning, Karen Sliwa, John Anthony, Ayesha Osman, Bernard Keavney, and Liesl Zühlke
Subjects: medicine.medical_specialty, Pediatrics, Heart disease, 030204 cardiovascular system & hematology, registry, Protea, RJ1-570, 03 medical and health sciences, 0302 clinical medicine, Double outlet right ventricle, Ductus arteriosus, Epidemiology, medicine, genetics, cardiovascular diseases, biorepository, 030304 developmental biology, Tetralogy of Fallot, Original Research, 0303 health sciences, biology, business.industry, medicine.disease, biology.organism_classification, congenital heart disease, 3. Good health, Stenosis, medicine.anatomical_structure, Cohort, Pediatrics, Perinatology and Child Health, Africa, epidemiology, business
Abstract: Objectives: The PartneRships in cOngeniTal hEart disease (PROTEA) project aims to establish a densely phenotyped and genotyped Congenital Heart Disease (CHD) cohort for southern Africa. This will facilitate research into the epidemiology and genetic determinants of CHD in the region. This paper introduces the PROTEA project, characterizes its initial cohort, from the Western Cape Province of South Africa, and compares the proportion or “cohort-prevalences” of CHD-subtypes with international findings.Methods: PROTEA is a prospective multicenter CHD registry and biorepository. The initial cohort was recruited from seven hospitals in the Western Cape Province of South Africa from 1 April 2017 to 31 March 2019. All patients with structural CHD were eligible for inclusion. Descriptive data for the preliminary cohort are presented. In addition, cohort-prevalences (i.e., the proportion of patients within the cohort with a specific CHD-subtype) of 26 CHD-subtypes in PROTEA's pediatric cohort were compared with the cohort-prevalences of CHD-subtypes in two global birth-prevalence studies.Results: The study enrolled 1,473 participants over 2 years, median age was 1.9 (IQR 0.4–7.1) years. Predominant subtypes included ventricular septal defect (VSD) (339, 20%), atrial septal defect (ASD) (174, 11%), patent ductus arteriosus (185, 11%), atrioventricular septal defect (AVSD) (124, 7%), and tetralogy of Fallot (121, 7%). VSDs were 1.8 (95% CI, 1.6–2.0) times and ASDs 1.4 (95% CI, 1.2–1.6) times more common in global prevalence estimates than in PROTEA's pediatric cohort. AVSDs were 2.1 (95% CI, 1.7–2.5) times more common in PROTEA and pulmonary stenosis and double outlet right ventricle were also significantly more common compared to global estimates. Median maternal age at delivery was 28 (IQR 23–34) years. Eighty-two percent (347/425) of mothers used no pre-conception supplementation and 42% (105/250) used no first trimester supplements.Conclusions: The cohort-prevalence of certain mild CHD subtypes is lower than for international estimates and the cohort-prevalence of certain severe subtypes is higher. PROTEA is not a prevalence study, and these inconsistencies are unlikely the result of true differences in prevalence. However, these findings may indicate under-diagnosis of mild to moderate CHD and differences in CHD management and outcomes. This reemphasizes the need for robust CHD epidemiological research in the region.
Published: 2021

21. Inflammation‐induced left ventricular fibrosis is partially mediated by tumor necrosis factor‐α

Author: Sule Gunter, Lebogang Mokotedi, Serena Fourie, Ashmeetha Manilall, Colleen A. Flanagan, Regina Le Roux, and Aletta M.E. Millen
Subjects: medicine.medical_specialty, MMP2, Physiology, Heart Ventricles, Anti-Inflammatory Agents, Arthritis, Inflammation, tumor necrosis factor alpha inhibitor, Systemic inflammation, Etanercept, Arthritis, Rheumatoid, Rats, Sprague-Dawley, Fibrosis, Physiology (medical), Internal medicine, QP1-981, Medicine, Animals, Ventricular Remodeling, business.industry, Tumor Necrosis Factor-alpha, Original Articles, medicine.disease, Arthritis, Experimental, Rats, Endocrinology, inflammation, gene expression, Myocardial fibrosis, Tumor necrosis factor alpha, Original Article, diastolic dysfunction, myocardial fibrosis, medicine.symptom, business, medicine.drug
Abstract: Objective To determine the mechanisms of inflammation‐induced left ventricular (LV) remodeling and effects of blocking circulating tumor necrosis factor alpha (TNF‐α) in a model of systemic inflammation. Methods Seventy Sprague‐Dawley rats were divided into three groups: the control group, the collagen‐induced arthritis (CIA) group, and the anti‐TNF‐α group. Inflammation was induced in the CIA and anti‐TNF‐α groups. Following the onset of arthritis, the anti‐TNF‐α group received the TNF‐α inhibitor, etanercept, for 6 weeks. LV geometry and function were assessed with echocardiography. Circulating inflammatory markers were measured by ELISA and LV gene expression was assessed by comparative TaqMan® polymerase chain reaction. Results The LV relative gene expression of pro‐fibrotic genes, transforming growth factor β (TGFβ) (p = 0.03), collagen I (Col1) (p 0.05) and tended to be lower compared to the CIA group (p = 0.06 and p = 0.08, respectively), and may, in part, contribute to the decreased relative wall thickness in the anti‐TNF‐α group compared to the CIA group (p = 0.03). In the CIA group, the relative gene expression of matrix metalloproteinase 2 (MMP2) and MMP9 was increased compared to control (p = 0.04) and anti‐TNF‐α (p, High‐grade systemic inflammation increases macrophage infiltration, pro‐fibrotic gene expression, and upregulates extracellular matrix turnover within left ventricular tissue. Inhibition of circulating TNF‐α, with the anti‐inflammatory drug etanercept, partially attenuates pro‐fibrotic gene expression and reduces extracellular matrix turnover, thereby preventing myocardial fibrosis and adverse left ventricular remodeling. Inflammation‐induced left ventricular diastolic dysfunction is likely independent of myocardial fibrosis.
Published: 2021

22. Implementation of a Bundle of Care in Colorectal Surgery to Reduce Surgical Site Infections Successfully at Cantonal Hospital Lucerne: Study Protocol for a Prospective Observational Study

Author: Jörn-Markus Gass, Irin Zschokke, Jürg Metzger, Dirk Lehnick, Jule Liesenberg, Stefanie Brunner, Lana Fourie, and Andreas Scheiwiller
Subjects: Protocol (science), medicine.medical_specialty, Potential risk, business.industry, surgical site infection, Colorectal surgery, Bundle, Emergency medicine, Surgical site, Clinical endpoint, medicine, Protocol, Surgery, Observational study, colorectal surgery, business, Surgical site infection, bundle of care
Abstract: Background: Surgical site infections (SSIs) remain a relevant problem in colorectal surgery. The aim of this study is to implement a bundle of care in order to reduce SSIs in colorectal surgery. Methods: All patients undergoing colorectal surgery between October 2018 and December 2021 will be included in a prospective observational study. Since our colorectal bundle has been established gradually, patients will be grouped in a preimplementation (2018–2019), implementation (2019–2020) and post implementation phase (2021), in order to assess the effectiveness of the actions undertaken. Primary endpoint of this study will be surgical site infection (SSI) rate, while secondary endpoints encompass potential risk factors for SSIs. We assume that obesity, age, diabetes, alcoholism and smoking may lead to a higher risk for SSIs. Discussion: This study aims to determine whether the colorectal bundle designed and implemented at Cantonal Hospital Lucerne, will lead to a significant reduction of SSIs. The impact of potential risk factors for SSIs will additionally be evaluated. Trial registration: ClinicalTrials.gov, ID: NCT04677686. Registered retrospectively 18 December 2020. Highlights: • A bundle of care might reduce the occurence of surgical site infections after colorectal surgery. • Analysis of risk factors may detect patient's with high probability of developing surgical site infections., + ID der Publikation: unilu_54967 + Sprache: Englisch + Letzte Aktualisierung: 2021-10-27 15:20:48
Published: 2021
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23. 1013 Dupuytren’s Contracture Treatment with XIAPEX Injection: Reviewing A Single Surgeon's Experience

Author: M Malik and B Fourie
Subjects: medicine.medical_specialty, business.industry, medicine, Surgery, Dupuytren's contracture, business, medicine.disease, Single surgeon
Abstract: Aim To review a single surgeon's experience for the treatment of Dupuytren's disease with XIAPEX injection and the clinical outcomes as measured by a URAM score. Method Retrospective review of patient notes, clinical photography and URAM scores for patients who underwent the procedure between August 2013 and October 2016. Results 33 patients underwent the procedure. 25 patients completed pre and post URAM scores. Average pre procedure score was 19.4 and avergae post procedure score was 3.28 a difference of 16.12 (clinically important change for URAM score is 2.9). Average pre procedure MCPJ contracture was 46.67 degrees and average post procedure contracture was 3.3 degrees. Average pre procedure PIPJ contracture was 66.8 degrees and average post procedure contracture was 8.2 degrees. Where both MCPJ and PIPJ affected of the same digit average pre procedure MCPJ and PIPJ contracture was 60 degrees. The post procedure contracture was 0 degrees in the MCPJ and 29.7 degrees in the PIPJ. 1 patient underwent surgery for progressive disease. Conclusions XIAPEX injection has shown a clinically significant result in the treatment of Dupuytren's disease. There were minimal complications and only 1 patient needed further surgery. However, a small sample size thus conclusions have to be cautious.
Published: 2021

24. Antimicrobial de-escalation in the critically ill patient and assessment of clinical cure : the DIANA study

Author: De Bus, Liesbet, Depuydt, Pieter, Steen, Johan, Dhaese, Sofie, De Smet, Ken, Tabah, Alexis, Akova, Murat, Cotta, Menino Osbert, De Pascale, Gennaro, Dimopoulos, George, Fujitani, Shigeki, Garnacho-Montero, Jose, Leone, Marc, Lipman, Jeffrey, Ostermann, Marlies, Paiva, José-Artur, Schouten, Jeroen, Sjövall, Fredrik, Timsit, Jean-François, Roberts, Jason A., Zahar, Jean-Ralph, Zand, Farid, Zirpe, Kapil, De Waele, Jan J., Fernando Rios, Alejandro Risso Vazquez, Maria Gabriela Vidal, Graciela Zakalik, Antony George Attokaran, Iouri Banakh, Smita Dey-Chatterjee, Julie Ewan, Janet Ferrier, Loretta Forbes, Cheryl Fourie, Anne Leditschke, Lauren Murray, Philipp Eller, Patrick Biston, Stephanie Bracke, Luc De Crop, Nicolas De Schryver, Eric Frans, Herbert Spapen, Claire Van Malderen, Stijn Vansteelandt, Daisy Vermeiren, Elias Pablo Arévalo, Mónica Crespo, Roberto Zelaya Flores, Petr Píza, Diego Morocho Tutillo, Andreas Elme, Anne Kallaste, Joel Starkopf, Jeremy Bourenne, Mathieu Calypso, Yves Cohen, Claire Dahyot-Fizelier, François Depret, Max Guillot, Nadia Imzi, Sebastien Jochmans, Achille Kouatchet, Alain Lepape, Olivier Martin, Markus Heim, Stefan J Schaller, Kostoula Arvaniti, Anestis Bekridelis, Panagiotis Ioannidis, Cornelia Mitrakos, Metaxia N Papanikolaou, Sofia Pouriki, Anna Vemvetsou, Babu Abraham, Pradip Kumar Bhattacharya, Anusha Budugu, Subhal Dixit, Sushma Gurav, Padmaja Kandanuri, Dattatray Arun Prabhu, Darshana Rathod, Kavitha Savaru, Ashwin Neelavar Udupa, Sunitha Binu Varghese, Hossein Haddad Bakhodaei, Gholamreza Dabiri, Mohammad Javad Fallahi, Farnia Feiz, Mohammad Firoozifar, Vahid Khaloo, Behzad Maghsudi, Mansoor Masjedi, Reza Nikandish, Golnar Sabetian, Brian Marsh, Ignacio Martin-Loeches, Jan Steiner, Maria Barbagallo, Anselmo Caricato, Andrea Cortegiani, Rocco D'Andrea, Cristian Deana, Abele Donati, Massimo Girardis, Giuliana Mandalà, Giovanna Panarello, Daniela Pasero, Lorella Pelagalli, Paolo Maurizio Soave, Savino Spadaro, Yoshihito Fujita, Shinsuke Fujiwara, Yuya Hara, Hideki Hashi, Satoru Hashimoto, Hideki Hashimoto, Katsura Hayakawa, Masash Inoue, Shutaro Isokawa, Shinya Kameda, Hidenobu Kamohara, Masafumi Kanamoto, Shinshu Katayama, Toshiomi Kawagishi, Yasumasa Kawano, Yoshiko Kida, Mami Kita, Atsuko Kobayashi, Akira Kuriyama, Takaki Naito, Hiroshi Nashiki, Kei Nishiyama, Shunsuke Shindo, Taketo Suzuki, Akihiro Takaba, Chie Tanaka, Komuro Tetsuya, Yoshihiro Tomioka, Youichi Yanagawa, Hideki Yoshida, Syamhanin Adnan, Mohd Shahnaz Hasan, Helmi Sulaiman, Gilberto A Gasca Lopez, Carmen M Hernández-Cárdenas, Silvio A Ñamendys-Silva, Carina Bethlehem, Dylan de Lange, Nicole Hunfeld, Sandra Numan, Henk van Leeuwen, Daniel Owens, Mónica Almeida, Elsa Fragoso, Tiago Leonor, José-Manuel Pereira, Daniela Filipescu, Ioana Grigoras, Mihai Popescu, Dana Tomescu, Mohammed S Alshahrani, Manuel Alvarez-Gonzalez, Irene Barrero-García, Miguel Angel Blasco-Navalpotro, Laura Claverias, Ángel Estella, Lorena Forcelledo Espina, Jose Luis Garcia Garmendia, Emilio García Prieto, Gracia Gómez-Prieto, Carlos Jiménez Conde, Fernando Martinez Sagasti, Alicia Muñoz Cantero, Alberto Orejas-Gallego, Elisabeth Papiol, Demetrio Pérez-Civantos, Juan Carlos Pozo Laderas, Josep Trenado Álvarez, Paula Vera-Artázcoz, Pablo Vidal Cortés, Anders Oldner, Martin Spångfors, Emine Alp, Iftihar Köksal, Volkan Korten, Arife Özveren, Anna Hall, Kevin W Hatton, Krzysztof Laudanski, Experimental and Applied Psychology, Clinique de réanimation médicale, Université Joseph Fourier - Grenoble 1 (UJF)-CHU Grenoble-Hôpital Michallon, Johns Hopkins Bloomberg School of Public Health [Baltimore], Johns Hopkins University (JHU), Microbes évolution phylogénie et infections (MEPHI), Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU)-Centre National de la Recherche Scientifique (CNRS), Service Anesthésie et Réanimation [Hôpital Nord - APHM], Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)- Hôpital Nord [CHU - APHM], University of Queensland [Brisbane], Centro Hospitalar Universitário São João - Faculty of Medicine - University of Porto - Grupo de Infecção e Sepsis, Porto, Radboud University Medical Center [Nijmegen], Skane University Hospital [Malmo], Lund University [Lund], Institut d'oncologie/développement Albert Bonniot de Grenoble (INSERM U823), Université Joseph Fourier - Grenoble 1 (UJF)-CHU Grenoble-EFS-Institut National de la Santé et de la Recherche Médicale (INSERM), Hôpital Avicenne [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Ghent University Hospital, Ghent, Belgium, De Bus, Liesbet, Depuydt, Pieter, Steen, Johan, Dhaese, Sofie, De Smet, Ken, Tabah, Alexi, Akova, Murat, Cotta, Menino Osbert, De Pascale, Gennaro, Dimopoulos, George, Fujitani, Shigeki, Garnacho-Montero, Jose, Leone, Marc, Lipman, Jeffrey, Ostermann, Marlie, Paiva, José-Artur, Schouten, Jeroen, Sjövall, Fredrik, Timsit, Jean-Françoi, Roberts, Jason A., Zahar, Jean-Ralph, Zand, Farid, Zirpe, Kapil, De Waele, Jan J., and Fernando Rios, Alejandro Risso Vazquez, Maria Gabriela Vidal, Graciela Zakalik, Antony George Attokaran, Iouri Banakh, Smita Dey-Chatterjee, Julie Ewan, Janet Ferrier, Loretta Forbes, Cheryl Fourie, Anne Leditschke, Lauren Murray, Philipp Eller, Patrick Biston, Stephanie Bracke, Luc De Crop, Nicolas De Schryver, Eric Frans, Herbert Spapen, Claire Van Malderen, Stijn Vansteelandt, Daisy Vermeiren, Elias Pablo Arévalo, Mónica Crespo, Roberto Zelaya Flores, Petr Píza, Diego Morocho Tutillo, Andreas Elme, Anne Kallaste, Joel Starkopf, Jeremy Bourenne, Mathieu Calypso, Yves Cohen, Claire Dahyot-Fizelier, François Depret, Max Guillot, Nadia Imzi, Sebastien Jochmans, Achille Kouatchet, Alain Lepape, Olivier Martin, Markus Heim, Stefan J Schaller, Kostoula Arvaniti, Anestis Bekridelis, Panagiotis Ioannidis, Cornelia Mitrakos, Metaxia N Papanikolaou, Sofia Pouriki, Anna Vemvetsou, Babu Abraham, Pradip Kumar Bhattacharya, Anusha Budugu, Subhal Dixit, Sushma Gurav, Padmaja Kandanuri, Dattatray Arun Prabhu, Darshana Rathod, Kavitha Savaru, Ashwin Neelavar Udupa, Sunitha Binu Varghese, Hossein Haddad Bakhodaei, Gholamreza Dabiri, Mohammad Javad Fallahi, Farnia Feiz, Mohammad Firoozifar, Vahid Khaloo, Behzad Maghsudi, Mansoor Masjedi, Reza Nikandish, Golnar Sabetian, Brian Marsh, Ignacio Martin-Loeches, Jan Steiner, Maria Barbagallo, Anselmo Caricato, Andrea Cortegiani, Rocco D'Andrea, Cristian Deana, Abele Donati, Massimo Girardis, Giuliana Mandalà, Giovanna Panarello, Daniela Pasero, Lorella Pelagalli, Paolo Maurizio Soave, Savino Spadaro, Yoshihito Fujita, Shinsuke Fujiwara, Yuya Hara, Hideki Hashi, Satoru Hashimoto, Hideki Hashimoto, Katsura Hayakawa, Masash Inoue, Shutaro Isokawa, Shinya Kameda, Hidenobu Kamohara, Masafumi Kanamoto, Shinshu Katayama, Toshiomi Kawagishi, Yasumasa Kawano, Yoshiko Kida, Mami Kita, Atsuko Kobayashi, Akira Kuriyama, Takaki Naito, Hiroshi Nashiki, Kei Nishiyama, Shunsuke Shindo, Taketo Suzuki, Akihiro Takaba, Chie Tanaka, Komuro Tetsuya, Yoshihiro Tomioka, Youichi Yanagawa, Hideki Yoshida, Syamhanin Adnan, Mohd Shahnaz Hasan, Helmi Sulaiman, Gilberto A Gasca Lopez, Carmen M Hernández-Cárdenas, Silvio A Ñamendys-Silva, Carina Bethlehem, Dylan de Lange, Nicole Hunfeld, Sandra Numan, Henk van Leeuwen, Daniel Owens, Mónica Almeida, Elsa Fragoso, Tiago Leonor, José-Manuel Pereira, Daniela Filipescu, Ioana Grigoras, Mihai Popescu, Dana Tomescu, Mohammed S Alshahrani, Manuel Alvarez-Gonzalez, Irene Barrero-García, Miguel Angel Blasco-Navalpotro, Laura Claverias, Ángel Estella, Lorena Forcelledo Espina, Jose Luis Garcia Garmendia, Emilio García Prieto, Gracia Gómez-Prieto, Carlos Jiménez Conde, Fernando Martinez Sagasti, Alicia Muñoz Cantero, Alberto Orejas-Gallego, Elisabeth Papiol, Demetrio Pérez-Civantos, Juan Carlos Pozo Laderas, Josep Trenado Álvarez, Paula Vera-Artázcoz, Pablo Vidal Cortés, Anders Oldner, Martin Spångfors, Emine Alp, Iftihar Köksal, Volkan Korten, Arife Özveren, Anna Hall, Kevin W Hatton, Krzysztof Laudanski
Subjects: Original, DELPHI METHOD, Critical Care and Intensive Care Medicine, GUIDELINES, law.invention, 0302 clinical medicine, Anti-Infective Agents, [SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases, law, Epidemiology, Medicine and Health Sciences, Antimicrobial de-escalation, EPIDEMIOLOGY, ComputingMilieux_MISCELLANEOUS, [SDV.MHEP.ME]Life Sciences [q-bio]/Human health and pathology/Emerging diseases, Ventilator-associated pneumonia, Intensive care unit, Anti-Bacterial Agents, 3. Good health, Intensive Care Units, STEWARDSHIP PROGRAM, [SDV.MP.VIR]Life Sciences [q-bio]/Microbiology and Parasitology/Virology, Cohort, Bacterial infection, Clinical cure, Empirical therapy, Adult, medicine.medical_specialty, Combination therapy, Critical Illness, ANTIBIOTIC-THERAPY, NO, 03 medical and health sciences, [SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system, BETA-LACTAM, Internal medicine, Settore MED/41 - ANESTESIOLOGIA, medicine, Humans, [SDV.MP.PAR]Life Sciences [q-bio]/Microbiology and Parasitology/Parasitology, VENTILATOR-ASSOCIATED PNEUMONIA, business.industry, SEPTIC SHOCK, R-PACKAGE, bacterial infection, 030208 emergency & critical care medicine, medicine.disease, [SDV.MP.BAC]Life Sciences [q-bio]/Microbiology and Parasitology/Bacteriology, Discontinuation, SEVERE SEPSIS, lnfectious Diseases and Global Health Radboud Institute for Health Sciences [Radboudumc 4], Carbapenems, 030228 respiratory system, Relative risk, business, De-escalation
Abstract: © 2020 The Author(s)., [Purpose]: The DIANA study aimed to evaluate how often antimicrobial de-escalation (ADE) of empirical treatment is performed in the intensive care unit (ICU) and to estimate the effect of ADE on clinical cure on day 7 following treatment initiation., [Methods]: Adult ICU patients receiving empirical antimicrobial therapy for bacterial infection were studied in a prospective observational study from October 2016 until May 2018. ADE was defined as (1) discontinuation of an antimicrobial in case of empirical combination therapy or (2) replacement of an antimicrobial with the intention to narrow the antimicrobial spectrum, within the first 3 days of therapy. Inverse probability (IP) weighting was used to account for time-varying confounding when estimating the effect of ADE on clinical cure., [Results]: Overall, 1495 patients from 152 ICUs in 28 countries were studied. Combination therapy was prescribed in 50%, and carbapenems were prescribed in 26% of patients. Empirical therapy underwent ADE, no change and change other than ADE within the first 3 days in 16%, 63% and 22%, respectively. Unadjusted mortality at day 28 was 15.8% in the ADE cohort and 19.4% in patients with no change [p = 0.27; RR 0.83 (95% CI 0.60–1.14)]. The IP-weighted relative risk estimate for clinical cure comparing ADE with no-ADE patients (no change or change other than ADE) was 1.37 (95% CI 1.14–1.64)., [Conclusion]: ADE was infrequently applied in critically ill-infected patients. The observational effect estimate on clinical cure suggested no deleterious impact of ADE compared to no-ADE. However, residual confounding is likely.
Published: 2020

25. Protecting patients’ skin during prone ventilation - the PRONEtect practice guidance document

Author: Dimitri Beeckman and Anika Fourie
Subjects: medicine.medical_specialty, business.industry, Medicine, business, Intensive care medicine, Prone ventilation
Published: 2021

26. Optimising Treatment Outcomes for Children and Adults Through Rapid Genome Sequencing of Sepsis Pathogens. A Study Protocol for a Prospective, Multi-Centre Trial (DIRECT)

Author: Adam D. Irwin, Lachlan J. M. Coin, Patrick N. A. Harris, Menino Osbert Cotta, Michelle J. Bauer, Cameron Buckley, Ross Balch, Peter Kruger, Jason Meyer, Kiran Shekar, Kara Brady, Cheryl Fourie, Natalie Sharp, Luminita Vlad, David Whiley, Scott A. Beatson, Brian M. Forde, David Paterson, Julia Clark, Krispin Hajkowicz, Sainath Raman, Seweryn Bialasiewicz, Jeffrey Lipman, Luregn J. Schlapbach, and Jason A. Roberts
Subjects: Adult, Microbiology (medical), personalised dosing, medicine.medical_specialty, sepsis diagnostics, medicine.drug_class, Immunology, Antibiotics, Pilot Projects, 030204 cardiovascular system & hematology, Microbiology, antimicrobials, Sepsis, 03 medical and health sciences, Cellular and Infection Microbiology, 0302 clinical medicine, Antibiotic resistance, Methods, medicine, Humans, Multicenter Studies as Topic, Prospective Studies, antimicrobial resistance, 030212 general & internal medicine, Dosing, Child, Intensive care medicine, business.industry, Australia, trial protocol, Bayes Theorem, medicine.disease, Antimicrobial, QR1-502, Anti-Bacterial Agents, Clinical trial, Treatment Outcome, Infectious Diseases, Minion, nanopore sequencing, Nanopore sequencing, business
Abstract: BackgroundSepsis contributes significantly to morbidity and mortality globally. In Australia, 20,000 develop sepsis every year, resulting in 5,000 deaths, and more than AUD$846 million in expenditure. Prompt, appropriate antibiotic therapy is effective in improving outcomes in sepsis. Conventional culture-based methods to identify appropriate therapy have limited yield and take days to complete. Recently, nanopore technology has enabled rapid sequencing with real-time analysis of pathogen DNA. We set out to demonstrate the feasibility and diagnostic accuracy of pathogen sequencing direct from clinical samples, and estimate the impact of this approach on time to effective therapy when integrated with personalised software-guided antimicrobial dosing in children and adults on ICU with sepsis.MethodsThe DIRECT study is a pilot prospective, non-randomized multicentre trial of an integrated diagnostic and therapeutic algorithm combining rapid direct pathogen sequencing and software-guided, personalised antibiotic dosing in children and adults with sepsis on ICU.Participants and interventionsDIRECT will collect microbiological and pharmacokinetic samples from approximately 200 children and adults with sepsis admitted to one of four ICUs in Brisbane. In Phase 1, we will evaluate Oxford Nanopore Technologies MinION sequencing direct from blood in 50 blood culture-proven sepsis patients recruited from consecutive patients with suspected sepsis. In Phase 2, a further 50 consecutive patients with suspected sepsis will be recruited in whom MinION sequencing will be combined with Bayesian software-guided (ID-ODS) personalised antimicrobial dosing.Outcome measuresThe primary outcome is time to effective antimicrobial therapy, defined as trough drug concentrations above the MIC of the pathogen. Secondary outcomes are diagnostic accuracy of MinION sequencing from whole blood, time to pathogen identification and susceptibility testing using sequencing direct from whole blood and from positive blood culture broth.DiscussionRapid pathogen sequencing coupled with antimicrobial dosing software has great potential to overcome the limitations of conventional diagnostics which often result in prolonged inappropriate antimicrobial therapy. Reduced time to optimal antimicrobial therapy may reduce sepsis mortality and ICU length of stay. This pilot study will yield key feasibility data to inform further, urgently needed sepsis studies. Phase 2 of the trial protocol is registered with the ANZCTR (ACTRN12620001122943).Trial registrationRegistered with the Australia New Zealand Clinical Trials Registry Number ACTRN12620001122943
Published: 2021

27. BS26 The partnerships in congenital heart disease in africa study (PROTEA): clinical characteristics and genetic findings from a South African congenital heart disease cohort

Author: Andre Brooks, George Comitis, Phaphama Magadla, Thomas Aldersley, Blanche Cupido, Raj Ramesar, Bernard Keavney, James Eales, John Anthony, Timothy F Spracklen, Bianca de Koning, Karen Sliwa, Ayesha Osman, Liesl Zühlke, Alistair Revell, Paul Human, Lenise Swanson, Rik De Decker, Nicole Saacks, Alexia Joachim, Barend Fourie, John Lawrenson, Malebogo Ngoepe, Gasnat Shaboodien, and Liam Swanson
Subjects: Pediatrics, medicine.medical_specialty, Heart disease, biology, business.industry, Cohort, medicine, medicine.disease, Protea, biology.organism_classification, business
Published: 2021

28. The Lancet Respiratory Medicine Commission: 2019 update: epidemiology, pathogenesis, transmission, diagnosis, and management of multidrug-resistant and incurable tuberculosis

Author: Keertan Dheda, Tawanda Gumbo, Gary Maartens, Kelly E Dooley, Megan Murray, Jennifer Furin, Edward A Nardell, Robin M Warren, Aliasgar Esmail, Edward Nardell, Leslie London, Erica Lessem, Jason Limberis, Grant Theron, Ruth McNerney, Stefan Niemann, David Dowdy, Annelies Van Rie, Jotam G Pasipanodya, Camilla Rodrigues, Taane G Clark, Frik A Sirgel, H Simon Schaaf, Kwok Chiu Chang, Christoph Lange, Payam Nahid, Bernard Fourie, Norbert Ndjeka, Andrew Nunn, GB Migliori, Zarir F Udwadia, C Robert Horsburgh, Gavin J Churchyard, Dick Menzies, Anneke C Hesseling, James A Seddon, Marcus Low, Salmaan Keshavjee, Eric Nuermberger, Helen McIlleron, Kevin P Fennelly, Amina Jindani, Ernesto Jaramillo, Nesri Padayatchi, Clifton E Barry, and Lancet Respiratory Medicine drug-resistant tuberculosis Commission group
Subjects: Pulmonary and Respiratory Medicine, medicine.medical_specialty, Tuberculosis, Antitubercular Agents, Disease, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Pharmacotherapy, Tuberculosis diagnosis, Tuberculosis, Multidrug-Resistant, Pulmonary Medicine, medicine, Humans, 030212 general & internal medicine, Dosing, Diarylquinolines, Intensive care medicine, Oxazoles, Societies, Medical, business.industry, Linezolid, medicine.disease, Regimen, 030228 respiratory system, chemistry, Nitroimidazoles, Pretomanid, Drug Therapy, Combination, Human medicine, Periodicals as Topic, Bedaquiline, business
Abstract: The Lancet Respiratory Medicine Commission on drug-resistant tuberculosis was published in 2017, which comprehensively reviewed and provided recommendations on various aspects of the disease. Several key new developments regarding drug-resistant tuberculosis are outlined in this Commission Update. The WHO guidelines on treating drug-resistant tuberculosis were updated in 2019 with a reclassification of second line anti-tuberculosis drugs. An injection-free MDR tuberculosis treatment regimen is now recommended. Over the past 3 years, advances in treatment include the recognition of the safety and mortality benefit of bedaquiline, the finding that the 9-11 month injectable-based 'Bangladesh' regimen was non-inferior to longer regimens, and promising interim results of a novel 6 month 3-drug regimen (bedaquiline, pretomanid, and linezolid). Studies of explanted lungs from patients with drug-resistant tuberculosis have shown substantial drug-specific gradients across pulmonary cavities, suggesting that alternative dosing and drug delivery strategies are needed to reduce functional monotherapy at the site of disease. Several controversies are discussed including the optimal route of drug administration, optimal number of drugs constituting a regimen, selection of individual drugs for a regimen, duration of the regimen, and minimal desirable standards of antibiotic stewardship. Newer rapid nucleic acid amplification test platforms, including point-of-care systems that facilitate active case-finding, are discussed. The rapid diagnosis of resistance to other drugs, (notably fluoroquinolones), and detection of resistance by targeted or whole genome sequencing will probably change the diagnostic landscape in the near future.
Published: 2019

29. 18F-FDG PET/CT as a Noninvasive Biomarker for Assessing Adequacy of Treatment and Predicting Relapse in Patients Treated for Pulmonary Tuberculosis

Author: Matsontso Mathebula, Maphoshane Nchabeleng, Ismaheel O. Lawal, Nontando Moeketsi, Mark Hatherill, Ingrid Moagi, Thabo Lengana, Bernard Fourie, and Mike Sathekge
Subjects: medicine.medical_specialty, Tuberculosis, Microbiological culture, business.industry, Gold standard, medicine.disease, 030218 nuclear medicine & medical imaging, 03 medical and health sciences, Regimen, 0302 clinical medicine, Pulmonary tuberculosis, Internal medicine, medicine, Radiology, Nuclear Medicine and imaging, Fdg pet ct, In patient, 030212 general & internal medicine, business, Body mass index
Abstract: Microbial culture is the gold standard for determining the effectiveness of tuberculosis treatment. End-of-treatment (EOT) 18F-FDG PET/CT findings are variable among patients with negative microbial culture results after completing a standard regimen of antituberculous treatment (ATT), with some patients having a complete metabolic response to treatment whereas others have residual metabolic activity (RMA). We herein determine the impact of findings on EOT 18F-FDG PET/CT on tuberculosis relapse in patients treated with a standard regimen of ATT for drug-sensitive pulmonary tuberculosis (DS-PTB). Methods: Patients who completed a standard regimen of ATT for DS-PTB and were declared cured based on a negative clinical and bacteriologic examination were prospectively recruited to undergo EOT 18F-FDG PET/CT. Images were assessed for the presence of RMA. Patients were subsequently followed up for 6 mo looking for symptoms of tuberculosis relapse. When new symptoms developed, relapse was confirmed with bacteriologic testing. Repeat 18F-FDG PET/CT was done in patients who relapsed. Results: Fifty-three patients were included (mean age, 37.81 ± 11.29 y), with 62% being male and 75% HIV-infected. RMA was demonstrated in 33 patients (RMA group), whereas 20 patients had a complete metabolic response to ATT (non-RMA group). There was a higher prevalence of lung cavitation in the RMA group (P = 0.035). The groups did not significantly differ in age, sex, presence of HIV infection, body mass index, or hemoglobin level (P > 0.05). On follow-up, no patients in the non-RMA group developed tuberculosis relapse. Three patients in the RMA group developed relapse. All patients who developed tuberculosis relapse had bilateral disease with lung cavitation. Conclusion: A negative EOT 18F-FDG PET/CT result is protective against tuberculosis relapse. Nine percent of patients with RMA after ATT may experience tuberculosis relapse within 6 mo of completing ATT. Bilateral disease with lung cavitation is prevalent among patients with tuberculosis relapse.
Published: 2019

30. 'How I was then and how I am now': an evaluation of the effects of being housed upon the Anxiety of Homeless persons in Regional Australia

Author: Linda L. Agnew, Nickie Murcell, Christopher F. Sharpley, Phillip Fourie, Mark Anderson, and Vicki Bitsika
Subjects: medicine.medical_specialty, medicine, Anxiety, medicine.symptom, Psychiatry, Psychology, Social Sciences (miscellaneous), Depression (differential diagnoses)
Abstract: Homelessness is universally regarded as an aversive condition, to be remedied by the provision of appropriate housing. However, although there are many reports of the negative effect of homelessnes...
Published: 2019

31. Report of 2 Novel Presentations of Subcutaneous Fat Necrosis of the Newborn

Author: H. Francois Jordaan, Willem Visser, A Fourie Bezuidenhout, Susanna M.H. Kannenberg, and Fatima Ahmed
Subjects: medicine.medical_specialty, Hypercalcaemia, business.industry, Abscess-like plaques, Case Report, Histology, lcsh:RL1-803, medicine.disease, Dermatology, Perinatal asphyxia, Langerhans cell histiocytosis, newborn, lcsh:Dermatology, medicine, Subcutaneous fat necrosis of the newborn, Fat necrosis, haemorrhage, Fat Necrosis, Complication, Panniculitis, business
Abstract: Subcutaneous fat necrosis of the newborn (SCFNN) is a rare form of panniculitis classically affecting healthy full-term infants. There are a number of predisposing factors including perinatal asphyxia. The condition generally has a benign course with spontaneous resolution, but monitoring for metabolic complications, in particular the potentially life-threatening complication of hypercalcaemia, is critical. The authors report 2 cases of preterm infants with perinatal asphyxia with atypical presentations of SCFNN: the first with bony involvement resembling Langerhans cell histiocytosis and with follicular pseudocarcinomatous hyperplasia on histology, and the second presenting with a huge haematoma requiring surgical debridement. Both cases were initially erroneously diagnosed as pyogenic infections.
Published: 2019

32. Cost-Effectiveness Analysis of Mesh Repair for Inguinal Hernia During a Humanitarian Surgical Mission in Rural Nigeria

Author: Florian Oehme, Frank J. P. Beeres, Eze Tobias Okwudili, Peter Nussbaumer, and Lana Fourie
Subjects: medicine.medical_specialty, Mesh repair, business.industry, General surgery, Cost-effectiveness analysis, 030230 surgery, medicine.disease, 03 medical and health sciences, Inguinal hernia, 0302 clinical medicine, 030220 oncology & carcinogenesis, Medicine, Surgery, Humanitarian surgery, business
Abstract: Background: Humanitarian short-term surgery missions remain under debate, even though the proportion of the burden of surgical diseases around the world that could be treated based on surgery is constantly rising. The primary objective of this study was to prove the cost-effectiveness (CE) of a hernia repair–teaching mission in the rural setting of Nigeria. Methods: We present a CE analysis (CEA) of a 2-week surgery mission performing inguinal hernias with mesh repair according to the Lichtenstein maneuver. All data were collected prospectively. The contribution to the local health system was measured based on the disability-adjusted life years (DALYs). Further on, the CEA was analyzed and separated for surgeons from Nigeria and Europe, respectively. Results: During this mission a total of 107 patients with 123 hernias were treated. An average of 6,61 DALYs per patient were averted. The total costs for the mission team amounted to $8485.26, with a total of $19,210.73 from a societal perspective. Single-procedure costs amounted to $198.87 per patient, with $39.35 per procedure from a patient perspective. The CEA showed $31.04/DALY averted from a societal perspective, $13.71/DALY averted from a provider perspective, and $6.81/DALY averted from a patient perspective. This was well below the threshold of $2790 (gross domestic product per capita). Sensitivity analysis showed robust results. Conclusion: With these results we proved CE and remained about 90 times below the threshold of the gross domestic product per capita.
Published: 2019

33. Continuously sutured versus linear-stapled anastomosis in 76 robotic-assisted Ivor Lewis esophagectomies

Author: F V Angehrn, Romano Schneider, Martin Bolli, M von Flüe, K J Neuschütz, Daniel C. Steinemann, and Lana Fourie
Subjects: Stapled anastomosis, medicine.medical_specialty, business.industry, Robotic assisted, Conduit implant, Perioperative care, Medicine, Ivor lewis, Surgery, business, American society of anesthesiologists
Abstract: Objective We introduced robotic-assisted Ivor Lewis esophagectomies (rob-E) using the da Vinci Xi in Oct. 2015. Two anastomotic techniques have been performed – continuously sutured (COSU) and linear-stapled (LIST). Aim of this study is to evaluate the two anastomotic techniques regarding perioperative outcomes in our experience. Methods Retrospective analysis of prospectively collected data between Oct. 2015 and Dec. 2020 including 76 patients. 45 underwent COSU and 31 LIST. Techniques are demonstrated with video material. Minor (Clavien-Dindo = 3b) morbidity, rate of anastomotic insufficiency, mortality, and duration of hospitalization were compared. Results Patient characteristics were as follows: median age of 69 (35-83) years in COSU and 70 (36-83) years in LIST (p = 0.575), male gender in 84.4% of COSU and 83.9% of LIST (p = 1.000), and physical status with American Society of Anesthesiologists score 3 in 62.2% of COSU and 67.7% of LIST (p = 0.771). Concerning tumor characteristics there were 91.1% adenocarcinomas in COSU and 96.8% in LIST (p = 0.642), whereas the others were squamous cell carcinomas and one neuroendocrine tumor in COSU. The tumors were stage II in 22.2% respectively 32.3% and stage III in 57.8% respectively 48.4% of COSU and LIST (p = 0.555). Comparison of minor morbidity occurring in 60.0% of COSU and 54.8% of LIST (p = 0.813), major morbidity in 8.9% respectively 16.1% (p = 0.473), incidence of anastomotic insufficiency in 8.9% of COSU and 6.5% of LIST (p = 1.000), rate of surgical reintervention necessary in 2.2% respectively 9.7% (p = 0.298) as well as mortality of 2.2% in COSU and 3.2% in LIST (p = 1.000) showed no difference. Median duration of hospitalization of 20 (13-49) days in COSU and 20 (14-62) in LIST (p = 0.423) did not differ. Conclusion In rob-E COSU and LIST show comparable results and a preferable technique cannot be determined yet. Our results do not support the results of previous reports (Cerfolio et al.) that demonstrated a superiority of LIST. While stapling the backside of the anastomosis in LIST impresses as an elegant way to overcome the surgical demanding part of the anastomosis, other disadvantages such as compromising perfusion of the gastric conduit may prevail and limit the benefits. Further studies with a larger cohort are planned in order to draw more decisive conclusions.
Published: 2021

34. Comparison of robotic-assisted and open Ivor Lewis esophagectomies in 321 patients of a single center: A case-matched analysis

Author: Martin Bolli, Daniel C. Steinemann, K J Neuschütz, Lana Fourie, F V Angehrn, Silvio Däster, and M von Flüe
Subjects: medicine.medical_specialty, Robotic assisted, business.industry, medicine.medical_treatment, General surgery, Single Center, Preoperative care, Esophagectomy, Perioperative care, medicine, Ivor lewis, Surgery, business, Neoadjuvant therapy, American society of anesthesiologists
Abstract: Objective We introduced robotic-assisted Ivor Lewis esophagectomies (rob-E) using the da Vinci Xi in Oct. 2015. Prior to that, esophagectomies were performed as open Ivor Lewis (open-E) procedures. Aim of this study is to evaluate the safety of rob-E in comparison to open-E procedures regarding perioperative outcomes. Methods Retrospective analysis of prospectively collected data between Feb. 1999 and Dec. 2020. A case-matched analysis, matching open-E to rob-E in a 1:1 manner, was conducted. Cases were matched regarding age, gender, American Society of Anesthesiologists (ASA) score, histological type of tumor, tumor location and stage. Results In the study period 321 patients underwent an esophagectomy. 76 received rob-E and 245 open-E. After matching the cases the comparison of preoperative patient and tumor characteristics revealed no differences between the rob-E and open-E group regarding age at time of operation with a median of 69.5 (35-83) respectively 70 (46-88) years (p = 0.900), gender with 84.2% male in both groups (p = 1.000), ASA score with 68.4% ASA 3 or 4 in both groups (p = 1.000), percentage of tumor stage III of 53.9% respectively 57.9% (p = 0.707), and rate of neoadjuvant treatment of 82.9% in rob-E and 81.6% in open-E (p = 1.000). Conversion from rob-E to open-E was never necessary. For rob-E versus open-E no difference was found regarding overall morbidity with 69.7% versus 60.5% (p = 0.307), major morbidity (Clavien-Dindo > = 3b) with 11.8% versus 14.5% (p = 0.811), incidence of anastomotic insufficiency with 7.9% versus 5.3% (p = 0.745), rate of surgical reintervention with 5.3% versus 7.9% (p = 0.745), and mortality with 2.6% versus 3.9% (p = 1.000). Postoperative details showed no difference including a similar duration of hospitalization with a median of 20 (13-62) respectively 18.5 (13-52) days (p = 0.368) and number of harvested lymph nodes with a median of 24.5 (7-59) in rob-E and 23 (2-64) in open-E (p = 0.203). Conclusion The introduction of rob-E in our institution was safe, as perioperative morbidity and mortality did not differ from the previously performed open-E. Overall, the incidence of major morbidity and anastomotic insufficiency in rob-E and open-E show a satisfactory rate compared to previous reports in literature. Further studies with a larger cohort of rob-E are planned in order to draw more decisive conclusions.
Published: 2021

35. Performance of plasma kisspeptin as a biomarker for miscarriage improves with gestation during the first trimester

Author: Maria Phylactou, Elisabeth Daniels, Rans Nadir, Lechun Huo, Lisa Yang, Pei Chia Eng, C. Kyriacou, Ewa Pacuszka, Bijal Patel, Alexander N Comninos, Edouard Mills, Maya Al-Memar, Tom Kelsey, Waljit S. Dhillo, Sophie A Clarke, Chioma Izzi-Engbeaya, H. Fourie, Tricia Tan, Tom Bourne, Ali Abbara, Paul Bech, University of St Andrews. School of Computer Science, University of St Andrews. Centre for Interdisciplinary Research in Computational Algebra, National Institute for Health Research, Imperial College Healthcare NHS Trust- BRC Funding, and Genesis Research Trust
Subjects: 0301 basic medicine, Kisspeptin, PREDICTION, QH301 Biology, T-NDAS, miscarriage, INVASION, Miscarriage, 0302 clinical medicine, Pregnancy, KISS-1, Chorionic Gonadotropin, beta Subunit, Human, Prospective Studies, ULTRASOUND, Reproductive Biology, Kisspeptins, 030219 obstetrics & reproductive medicine, Obstetrics, Obstetrics & Gynecology, WOMEN, Obstetrics and Gynecology, Gestational age, PROTEIN-COUPLED RECEPTOR, PREGNANCY, RG Gynecology and obstetrics, Biomarker (medicine), Gestation, Original Article, Female, Life Sciences & Biomedicine, hormones, hormone substitutes, and hormone antagonists, EXPRESSION, QA75, medicine.medical_specialty, MIGRATION, QA75 Electronic computers. Computer science, Down-Regulation, Gestational Age, Ultrasonography, Prenatal, 1117 Public Health and Health Services, QH301, TROPHOBLAST, 03 medical and health sciences, SDG 3 - Good Health and Well-being, Predictive Value of Tests, medicine, Humans, Obstetrics & Reproductive Medicine, Science & Technology, business.industry, 1103 Clinical Sciences, medicine.disease, Confidence interval, Abortion, Spontaneous, Pregnancy Trimester, First, 030104 developmental biology, Reproductive Medicine, Case-Control Studies, 1114 Paediatrics and Reproductive Medicine, RG, business, Biomarkers, Blood sampling
Abstract: Supported by the National Institute for Health Research (NIHR) Clinical Research Facility and the NIHR Biomedical Research Centre based at Imperial College Healthcare National Health Services (NHS) Trust. The Section of Endocrinology and Investigative Medicine is funded by grants from the Medical Research Council and NIHR. A.A. is supported by an NIHR Clinician Scientist award (CS-2018-18-ST2-002). M.A.M. is supported by Tommy’s National Centre for Miscarriage Research . C.I.-E. is supported by an Imperial College-Biomedical Research Centre Imperial Post-doctoral, Post-CCT Research Fellowship. L.Y. is supported by an Medical Research Council Clinical Training Fellowship (MR/R000484/1). A.N.C. is supported by the NHS and Biomedical Research Centre. T.B. is supported by the NIHR Biomedical Research Centre based at Imperial College Healthcare NHS Trust. W.S.D. is supported by an NIHR Research Professorship (RP-2014-05-001). Objective: To compare the performance of kisspeptin and beta human chorionic gonadotropin (βhCG), both alone and in combination, as biomarkers for miscarriage throughout the first trimester. Design: Prospective, nested case-control study. Setting: Tertiary Centre, Queen Charlotte Hospital, London, United Kingdom. Patient(s): Adult women who had miscarriages (n = 95, 173 samples) and women with healthy pregnancies (n = 265, 557 samples).Intervention(s)The participants underwent serial ultrasound scans and blood sampling for measurement of plasma kisspeptin and βhCG levels during the first trimester. Main Outcome Measure(s): The ability of plasma kisspeptin and βhCG levels to distinguish pregnancies complicated by miscarriage from healthy pregnancies unaffected by miscarriage. Result(s): Gestation-adjusted levels of circulating kisspeptin and βhCG were lower in samples from women with miscarriages than in women with healthy pregnancies by 79% and 70%, respectively. The area under the receiver-operating characteristic curve for identifying miscarriage during the first trimester was 0.874 (95% confidence interval [CI] 0.844–0.904) for kisspeptin, 0.859 (95% CI 0.820–0.899) for βhCG, and 0.916 (95% CI 0.886–0.946) for the sum of the two markers. The performance of kisspeptin in identifying miscarriage improved with increasing length of gestation, whereas that of βhCG worsened. A decision matrix incorporating kisspeptin, βhCG, and gestational age had 83% to 87% accuracy for the prediction of miscarriage. Conclusion(s): Plasma kisspeptin is a promising biomarker for miscarriage and provides additional value to βhCG alone, especially during later gestational weeks of the first trimester. Publisher PDF
Published: 2021

36. Small crystals with severe consequences

Author: Otto Kollmar, Caspar Joyce Peterson, T. Boldanova, Jennifer M Klasen, Luigi Terracciano, Andreas Holbro, and Lana Fourie
Subjects: medicine.medical_specialty, Necrosis, AcademicSubjects/MED00910, medicine.medical_treatment, education, Ischemia, Case Report, 030204 cardiovascular system & hematology, Gastroenterology, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, medicine, Ingestion, Large intestine, Adverse effect, business.industry, Stomach, medicine.disease, medicine.anatomical_structure, 030220 oncology & carcinogenesis, Surgery, Gastrectomy, jscrep/0160, medicine.symptom, Gastritis, business
Abstract: We present the case of a 23-year-old patient who developed a severe gastric ischemia after the ingestion of a single dose of sodium polystyrene sulfonate (SPS) orally. Emergency surgery confirmed extensive full thickness gastric necrosis, prompting a total gastrectomy. Histopathology showed kayexalate crystals in the gastric wall, suggesting SPS-related ischemic gastritis. After radical resection of the affected stomach, this young patient was able to fully recover. Although effective, the widespread use of SPS to treat hyperpotassemia remains a debated topic because of rare but serious adverse events like the forming of kayexalate crystal residues in the gastrointestinal tract. These crystal residues are mostly found in the large intestine and can lead to ulceration and necrosis. Physicians need to be aware of this rare but potentially devastating adverse effect of SPS ingestion.
Published: 2021

37. Arterial structure and function in Africans with HIV for 5 years: longitudinal relationship with endothelial activation and cardiovascular risk markers

Author: E Phalane, Alta Schutte, C.M.C. Mels, Cmt Fourie, and Iolanthé M. Kruger
Subjects: 0301 basic medicine, Male, medicine.medical_specialty, Mean arterial pressure, Human immunodeficiency virus (HIV), Blood Pressure, HIV Infections, Pulse Wave Analysis, medicine.disease_cause, Carotid Intima-Media Thickness, Endothelial activation, 03 medical and health sciences, 0302 clinical medicine, Vascular Stiffness, Risk Factors, Internal medicine, medicine, Humans, Pharmacology (medical), 030212 general & internal medicine, Pulse wave velocity, Arterial injury, Arterial structure, business.industry, Health Policy, Arteries, 030112 virology, Antiretroviral therapy, Infectious Diseases, North west, Cardiovascular Diseases, Heart Disease Risk Factors, Cardiology, Female, business
Abstract: OBJECTIVES We aimed to determine whether people with human immunodeficiency virus (PWHIV) have increased measures of arterial injury [carotid intima-media thickness (cIMT)] and large artery stiffness [carotid-femoral pulse wave velocity (cfPWV)] when compared with their counterparts without HIV, and whether baseline markers of endothelial activation and cardiovascular risk are associated with cIMT and cfPWV after 5 years. METHODS We matched 126 PWHIV from North West Province, South Africa, to 126 without HIV according to age, sex and locality. Cardiovascular risk and endothelial function markers [soluble intracellular adhesion molecule (ICAM-1) and soluble vascular cell adhesion molecule (VCAM-1)] were measured at baseline and cIMT and cfPWV at follow-up. RESULTS This study included 21.4% men. The use of antiretroviral therapy (ART) increased from 44.1% at baseline to 81.4% at follow-up. At follow-up, cIMT (P = 0.90) and cfPWV (P = 0.35) were similar in the groups. Despite elevated ICAM-1 and VCAM-1 in the PWHIV (all P
Published: 2021

38. Causative pathogens and antibiotic resistance in community-acquired urinary tract infections in central South Africa

Author: J L Fourie, F M Claassen, and J J Myburgh
Subjects: Male, medicine.medical_specialty, Klebsiella, medicine.drug_class, Antibiotics, Urine, South Africa, Antibiotic resistance, Internal medicine, Drug Resistance, Bacterial, medicine, Escherichia coli, Humans, Retrospective Studies, biology, business.industry, General Medicine, Amoxicillin, biology.organism_classification, Antimicrobial, Anti-Bacterial Agents, Ciprofloxacin, Community-Acquired Infections, Nitrofurantoin, Urinary Tract Infections, Female, business, medicine.drug
Abstract: Background. Urinary tract infections (UTIs) are very common in community practice. Both the South African (SA) antibiotic stewardship programme (2015) and the Essential Medicines List for SA (2018) recommend ciprofloxacin as first-line treatment for community-acquired urinary tract infections (CAUTIs). The pathogens responsible for CAUTIs and their susceptibility profiles need to be documented, which is important for developing and updating treatment protocols. Objectives. To determine the causative pathogens of CAUTIs in the greater Bloemfontein area, central SA, and to review their susceptibilities to commonly prescribed antibiotics. Methods. Urine samples sent for microscopy and culture between 2011 and 2015 by the three largest primary healthcare facilities in Bloemfontein were analysed retrospectively. Specimens with a significant count (>105 CFU/mL) of a single uropathogen were included. These results were obtained from the National Health Laboratory Service central data warehouse after the required consent. Data regarding age, gender, pathogen cultured and antimicrobial susceptibilities were captured. All calculations were carried out with statistical analysis software SPSS 17.0 (SPSS Inc., USA). Results. A total of 712 samples met the inclusion criteria. Women accounted for 481 (67.6%) of the infections. The prevalence of UTIs per age group was as follows: 1 month - 25 years ( n =146; 20.51%); 26 - 50 years ( n =324; 45.5%); and 51 - 75 years ( n =199; 27.9%). The distribution of pathogens did not differ between age groups. Escherichia coli was the most prevalent uropathogen cultured from 410 (57.6%) specimens, followed by Klebsiella spp. from 97 (13.6%) and Enterococcus spp. from 71 (10.0%) specimens. E. coli showed resistance rates of 77.1% to amoxicillin, 15.6% to amoxicillin-clavulanate, 18.5% to ciprofloxacin, 4% to nitrofurantoin and 11% to trimethoprim-sulfamethoxazole (TMP-SMX). The distribution of uropathogens was different for men and women, with a lower prevalence of E. coli in men ( p =0.045). Conclusions. As expected, E. coli comprised most of the isolates, with a higher than expected number of Klebsiella isolates cultured. The susceptibility of E. coli to commonly prescribed oral antibiotics has decreased in the research setting, which mirrors a global trend. This study provides data showing that TMP-SMX and nitrofurantoin can be used safely as alternatives to first-line ciprofloxacin in CAUTIs in central SA.
Published: 2021

39. World Association for the Advancement of Veterinary Parasitology (W.A.A.V.P.) guidelines for studies evaluating the efficacy of parasiticides in reducing the risk of vector-borne pathogen transmission in dogs and cats

Author: Vincenzo Lorusso, Luigi Gradoni, Josephus J. Fourie, Ronald Kaminsky, Jason Drake, Bettina Schunack, Domenico Otranto, Peter Holdsworth, Thomas Geurden, Marie Varloud, Frederic Beugnet, Matthias Pollmeier, Filipe Dantas-Torres, and Anja Regina Heckeroth
Subjects: 0301 basic medicine, Societies, Scientific, Veterinary Medicine, medicine.medical_specialty, Veterinary parasitology, 040301 veterinary sciences, Parasitic Diseases, Animal, Biology, Cat Diseases, law.invention, 0403 veterinary science, 03 medical and health sciences, Dogs, law, Basic research, medicine, Animals, Dog Diseases, Intensive care medicine, General Veterinary, Antiparasitic Agents, 04 agricultural and veterinary sciences, General Medicine, 030108 mycology & parasitology, Transmission (mechanics), Vector (epidemiology), Practice Guidelines as Topic, Cats, Parasitology
Abstract: These guidelines are intended to provide an in-depth review of current knowledge and assist the planning and implementation of studies for evaluating the efficacy of parasiticides in reducing transmission of vector-borne pathogens (VBPs) to dogs and cats. At present, the prevention of VBP transmission in companion animals is generally achieved through the administration of products that can repel or rapidly kill arthropods, thus preventing or interrupting feeding before transmission occurs. The present guidelines complement existing guidelines, which focus on efficacy assessment of parasiticides for the treatment, prevention and control of flea and tick infestations, but also give guidance for studies focused on other vectors (i.e. mosquitoes and phlebotomine sand flies). The efficacy of parasiticides in reducing VBP transmission can be evaluated through laboratory or field studies. As such, the present guidelines provide recommendations for these studies, representing a tool for researchers, pharmaceutical companies and authorities involved in the research, development and registration of products with claims for reducing VBP transmission in dogs and cats, respecting the overall principles of the 3Rs (replacement, reduction and refinement). Gaps in our current understanding of VBP transmission times are herein highlighted and the need for further basic research on related topics is briefly discussed.
Published: 2021

40. The measurement properties of assessment tools for chronic wounds : a systematic review

Author: Hilde Beele, Samantha Holloway, Sebastian Probst, Dimitri Beeckman, Steven Smet, and Anika Fourie
Subjects: medicine.medical_specialty, Leg ulcer, MEDLINE, Decision support systems, Pressure ulcer, Validity, 03 medical and health sciences, 0302 clinical medicine, Quality of life (healthcare), medicine, Content validity, Criterion validity, Medicine and Health Sciences, Humans, Medical physics, Measurement invariance, 030212 general & internal medicine, Chronic wound, Reliability (statistics), General Nursing, Aged, Foot ulcer, 030504 nursing, business.industry, Reproducibility of Results, Construct validity, Reliability, Checklist, Scale (social sciences), Quality of Life, Systematic review, 0305 other medical science, business, Measurement properties
Abstract: Background Chronic wounds are an increasing problem in the aging population, patients experience a lower health-related quality of life and the care for these patients is associated with high costs. Thorough wound assessments facilitate objective monitoring of wound status and progress. A wound assessment tool can guide clinicians in these wound assessments and in recording wound progress or deterioration. Objective Systematically identify assessment tools for chronic wounds, investigate their measurement properties, and summarize the data per assessment tool. Design Systematic review Methods The databases Medline (PubMed interface), Embase, CINAHL, and CENTRAL were systematically searched until May 2020 (updated in February 2021). Studies reporting the development and/or the evaluation of measurement properties of assessment tools for chronic wounds were included. The “Consensus-based Standards for the selection of health Measurement Instruments” risk of Bias checklist was applied to evaluate the methodological quality of the included studies. Each reported measurement property was rated against criteria for good measurement properties. The evidence was summarized and the quality of the evidence was graded using a modified Grades of Recommendation, Assessment, Development, and Evaluation approach. Study selection, data extraction and quality appraisal were conducted independently by two reviewers and double-checked by a third reviewer. Results Twenty-seven studies describing the measurement properties of fourteen assessment tools for chronic wounds were included. None of the studies reported a content validity evaluation by a relevance study or a comprehensiveness study in professionals. Six articles reported the development or revision of an existing assessment tool. The reported measurement properties included: structural validity (5 studies), reliability (18 studies), hypotheses testing for construct validity (18 studies) and responsiveness (7 studies). Internal consistency, cross-cultural validity / measurement invariance and measurement error were not reported. If criterion validity was assessed, the results were allocated to hypotheses testing for construct validity as no ‘gold standard’ is available. Conclusions Fourteen assessment tools for chronic wounds were identified. Construct validity (by hypotheses testing) and responsiveness of the Pressure Ulcer Scale for Healing version 3.0 were supported by sufficient ratings based on moderate to high level quality of evidence. Reliability of the (Revised) Photographic Wound Assessment Tool had a sufficient rating based on moderate quality of evidence. The ratings of the measurement properties of the other wound assessment tools were either insufficient or indeterminate, or a sufficient result was supported by low to very low quality of evidence. Registration number in PROSPERO: CRD42020183920 Tweetable abstract: A systematic review giving a clear overview of the measurement properties of available assessment tools for chronic wounds.
Published: 2021

41. Metabolomic Biomarkers Are Associated With Area of the Pons in Fragile X Premutation Carriers at Risk for Developing FXTAS

Author: Marwa Zafarullah, Blythe Durbin-Johnson, Emily S. Fourie, David R. Hessl, Susan M. Rivera, and Flora Tassone
Subjects: Oncology, Longitudinal study, medicine.medical_specialty, Ataxia, premutation carriers, Intellectual and Developmental Disabilities (IDD), Clinical Sciences, RC435-571, Neurodegenerative, Pathogenesis, lipids, Metabolomics, Rare Diseases, Clinical Research, Internal medicine, medicine, 2.1 Biological and endogenous factors, Psychology, brain measures, Allele, Aetiology, Original Research, Psychiatry, screening and diagnosis, business.industry, fragile X-associated tremor/ataxia syndrome, Neurosciences, medicine.disease, FMR1, Pons, Brain Disorders, 4.1 Discovery and preclinical testing of markers and technologies, Psychiatry and Mental health, Detection, area of the pons, Fragile X Syndrome, Neurological, ataxia syndrome, Public Health and Health Services, Mental health, medicine.symptom, metabolic biomarkers, business, fragile X-associated tremor, Fragile X-associated tremor/ataxia syndrome
Abstract: Fragile X-associated tremor/ataxia syndrome (FXTAS) is a late adult-onset neurodegenerative disorder that affects movement and cognition in male and female carriers of a premutation allele (55–200 CGG repeats; PM) in the fragile X mental retardation (FMR1) gene. It is currently unknown how the observed brain changes are associated with metabolic signatures in individuals who develop the disorder over time. The primary objective of this study was to investigate the correlation between longitudinal changes in the brain (area of the pons, midbrain, and MCP width) and the changes in the expression level of metabolic biomarkers of early diagnosis and progression of FXTAS in PM who, as part of an ongoing longitudinal study, emerged into two distinct categories. These included those who developed symptoms of FXTAS (converters, CON) at subsequent visits and those who did not meet the criteria of diagnosis (non-converters, NCON) and were compared to age-matched healthy controls (HC). We assessed CGG repeat allele size by Southern Blot and PCR analysis. Magnetic Resonance Imaging (MRIs) acquisition was obtained on a 3T Siemens Trio scanner and metabolomic profile was obtained by ultra-performance liquid chromatography, accurate mass spectrometer, and an Orbitrap mass analyzer. Our findings indicate that differential metabolite levels are linked with the area of the pons between healthy control and premutation groups. More specifically, we observed a significant association of ceramides and mannonate metabolites with a decreased area of the pons, both at visit 1 (V1) and visit 2 (V2) only in the CON as compared to the NCON group suggesting their potential role in the development of the disorder. In addition, we found a significant correlation of these metabolic signatures with the FXTAS stage at V2 indicating their contribution to the progression and pathogenesis of FXTAS. Interestingly, these metabolites, as part of lipid and sphingolipid lipids pathways, provide evidence of the role that their dysregulation plays in the development of FXTAS and inform us as potential targets for personalized therapeutic development.
Published: 2021

42. L‐homoarginine is associated with decreased cardiovascular‐ and all‐cause mortality

Author: Carla M.T. Fourie, Catharina M. C. Mels, Rainer H. Böger, Shani Botha-Le Roux, Maserame Cleopatra Mokhaneli, and Edzard Schwedhelm
Subjects: Adult, Male, medicine.medical_specialty, Vascular homeostasis, Clinical Biochemistry, Disease, 030204 cardiovascular system & hematology, Biochemistry, Gastroenterology, 03 medical and health sciences, 0302 clinical medicine, Cause of Death, Internal medicine, medicine, Humans, 030212 general & internal medicine, Mortality, Beneficial effects, Aged, Proportional Hazards Models, Proportional hazards model, business.industry, Hazard ratio, General Medicine, Middle Aged, Protective Factors, Homoarginine, Verbal autopsy, Cardiovascular Diseases, Multivariate Analysis, Female, L-homoarginine, business, All cause mortality
Abstract: BACKGROUND Increasing evidence suggests that L-homoarginine, an endogenous analogue of the amino acid L-arginine, may have beneficial effects on vascular homeostasis. We examined whether L-homoarginine is associated with 10-year risk of all-cause and cardiovascular mortality in a black South African population. METHODS We included 669 black South African participants (mean age 59.5 years), 143 of whom died during the 10-year follow-up period. Mortality data were acquired via verbal autopsy. Plasma L-homoarginine (and other related markers) were analysed with liquid chromatography-tandem mass spectrometry. RESULTS Survivors had higher L-homoarginine levels compared with nonsurvivors (1.25 µM vs. 0.89 µM; P
Published: 2020

43. Recent advances in understanding hypertension development in sub-Saharan Africa

Author: C.M.T. Fourie, Hugo W. Huisman, Catharina M. C. Mels, Ruan Kruger, Leandi Lammertyn, Lebo F. Gafane-Matemane, Aletta E. Schutte, R. Schutte, Wayne Smith, Leoné Malan, Shani Botha, J.M. Van Rooyen, Lisa J. Ware, 10922180 - Schutte, Aletta Elisabeth, 10062491 - Fourie, Catharina Maria Theresia, 10060871 - Malan, Leoné, 10062718 - Huisman, Hugo Willem, 12076341 - Mels, Catharina Martha Cornelia, 10059539 - Van Rooyen, Johannes Marthinus, 12201405 - Schutte, Rudolph, 20035632 - Kruger, Ruan, 20088310 - Lammertyn, Leandi, 22945717 - Smith, Wayne, 24398330 - Ware, Lisa Jayne, 20695241 - Botha, Shani, and 24341185 - Gafane-Matemane, Lebo Francina
Subjects: medicine.medical_specialty, Pathology, Health Behavior, Black People, Blood Pressure, Comorbidity, Disease, 030204 cardiovascular system & hematology, Severity of Illness Index, 03 medical and health sciences, Medical research, 0302 clinical medicine, Risk Factors, Severity of illness, Internal Medicine, medicine, Humans, 030212 general & internal medicine, Age of Onset, Endothelial dysfunction, Intensive care medicine, Life Style, Africa South of the Sahara, Antihypertensive Agents, Subclinical infection, business.industry, Incidence (epidemiology), Prognosis, medicine.disease, Blood pressure, Risk factors, Hypertension, Age of onset, business
Abstract: Consistent reports indicate that hypertension is a particularly common finding in black populations. Hypertension occurs at younger ages and is often more severe in terms of blood pressure levels and organ damage than in whites, resulting in a higher incidence of cardiovascular disease and mortality. This review provides an outline of recent advances in the pathophysiological understanding of blood pressure elevation and the consequences thereof in black populations in Africa. This is set against the backdrop of populations undergoing demanding and rapid demographic transition, where infection with the human immunodeficiency virus predominates, and where under and over-nutrition coexist. Collectively, recent findings from Africa illustrate an increased lifetime risk to hypertension from foetal life onwards. From young ages black populations display early endothelial dysfunction, increased vascular tone and reactivity, microvascular structural adaptions as well as increased aortic stiffness resulting in elevated central and brachial blood pressures during the day and night, when compared to whites. Together with knowledge on the contributions of sympathetic activation and abnormal renal sodium handling, these pathophysiological adaptations result in subclinical and clinical organ damage at younger ages. This overall enhanced understanding on the determinants of blood pressure elevation in blacks encourages (a) novel approaches to assess and manage hypertension in Africa better, (b) further scientific discovery to develop more effective prevention and treatment strategies and (c) policymakers and health advocates to collectively contribute in creating health-promoting environments in Africa.
Published: 2017

44. Ticagrelor in patients with diabetes and stable coronary artery disease with a history of previous percutaneous coronary intervention (THEMIS-PCI): a phase 3, placebo-controlled, randomised trial

Author: Deepak L Bhatt, Philippe Gabriel Steg, Shamir R Mehta, Lawrence A Leiter, Tabassome Simon, Kim Fox, Claes Held, Marielle Andersson, Anders Himmelmann, Wilhelm Ridderstråle, Jersey Chen, Yang Song, Rafael Diaz, Shinya Goto, Stefan K James, Kausik K Ray, Alexander N Parkhomenko, Mikhail N Kosiborod, Darren K McGuire, Robert A Harrington, Vladimir Santos, Ashit Jain, Irina Lendel, Michael Russo, W H Haught, Manuel Bouza, Harinder Gogia, Supratim Banerjee, George Kichura, Louis Kantaros, Francisco Padron, Rakesh Passi, Jay Stone, Michael Pursley, Michael D'Urso, Timothy Gardner, James Bennett, Khaled Nour, Satinder Saini, Wenwu Zhang, Dharam Kumbhani, Dustin Thomas, Dominick Angiolillo, Barry Bertolet, Amaury Roman-Miranda, Robert Black, Ramin Manshadi, Carlos Vaca, Antonio Blanco, Mark Napoli, David Brabham, Ayim Akyea-Djamson, Pratik Desai, Sudhir Prasada, Ajit Khaira, Leslie Forgosh, Ira Lieber, Guillermo Umpierrez, Dinesh Singal, Juan Londono, Neil Fraser, Jose Ruiz, Damaris Vega, Lilia Rodriguez, Christopher Brown, Faizullah Syed, Guarav Aggarwala, William Eaves, Michael Foster, Dinesh Gupta, David Avino, Wail Asfour, Glen Tonnessen, Xue-Qiao Zhao, Narendra Singh, Andrew Brockmyre, Norman Lepor, Nicolas Shammas, David Blick, Steven Hearne, John Prodafikas, Edgar Carell, Mark Izzo, Amin Karim, Bosh Zakhary, Mahmoud Atieh, Steven Leichter, Charles Meadows, David Hotchkiss, Mazen Abu-Fadel, Alan Wiseman, Jeffrey Bander, Mahesh Shah, Subhash Banerjee, Ricky Ganim, Karen Sopko, Misal Khan, Ramon Lloret, Troy Weirick, Rajendra Mehta, Udho Thadani, Anuj Bhargava, Mikhail Kosiborod, Jaynier Moya, Cezar Staniloae, Yamirka D Guerra, Anil Chhabra, Douglas Kosmicki, Wassim Shaheen, Akber Mohammed, J'Cinda Bitters, Jan Pattanayak, Julian Javier, Sunny Srivastava, Roland Phillips, Jessie Al-Amin, Michael Lillestol, Patrick Simpson, Lydie Hazan, Amit Amin, Gopi Shah, Denes Korpas, Bruce Platt, Jim Dickert, Orlando Puente, Louis Hiotis, Timothy Doyle, Raj Rajan, Alan Meholick, Christian Gring, Elie Hage-Korban, Robert Feldman, Harry Colfer, Samuel Butman, Malcolm Foster, Terence Hart, Randall Huling, Shervin Eshaghian, Ofsman Quintana, Deanna Cheung, Franklin Handel, Mara Rodriguez, David Suh, Paul Gordon, Gregg Pressman, Michael Bauer, William French, Mark Barettella, Sridhar Chatrathi, Damodhar Suresh, Ronald Goldberg, Mark Huth, Liwa Younis, Aref Rahman, Richard Mascolo, Michelle Welch, Randeep Suneja, Stephen Smith, Scott Shurmur, John Agaiby, Ahmad Jingo, Janice Johnston, Mary Beth, Anthony Vlastaris, Susan Kemp, Hamid Taheri, Edward Pereira, Michael Deyoung, Zafir Hawa, Ray Smith, Thomas Galski, Samer Garas, M Reddy, Susheel Sharma, Joeseph Hargrove, Charles Treasure, Ronald Emerson, Tariq Haddad, Kathryn Rohr, Larry Levinson, Raul Gaona, Barry Uretsky, Hiralal Maheshwari, Denny Lee, Stephanie Kinnaman, Robert Singal, Jeffrey Geohas, Osvaldo Gigliotti, Ajit Raisinghani, Charanjit Khurana, Brent Hella, Michael Kelberman, Steven Voyce, Sanjay Singh, Eric Lo, Pradeep Singh, Ross Goodfellow, Stuart Fischer, Richard Lorraine, Traci Turner, Jeffrey Shanes, Robert Busch, Robert Broker, Michelle Zaniewski, Kevin Pounds, Giselle Debs-Perez, Stephen Ong, Brad Frandsen, Douglas Fullington, Naseem Jaffrani, Ahtaram Khan, Marcus Lee, Joe Pouzar, George Revtyak, Julian Gonzalez, Samer Nakhle, Abel Murillo, Douglas Young, Sashi Makam, Mushtaq Syed, Kevin Woolf, Paul Grena, Sarab Alfata, Sharan Mahal, David Hoffman, Tinoy Kizhakekuttu, Joseph Deering, Janak Bhavsar, Scott Mikesell, William Wilson, Vance Wilson, Salah El, Francis Spinale, Vinod Kannarkat, Sunder Rao, Lenita Hanson, John Bertsch, Elena Gonzalez-Ortiz, Norma Severino, John Willis, Joel Schock, Ladan Bakhtari, Raul Gazmuri, Saadat Ansari, Jason Hall, Arvind Mehta, Neal Shealy, Stuart Zarich, Deovrat Singh, Kishor Vora, Nabil Andrawis, Darron Molter, David Maron, Jose Cardona, Ronald D'Agostino, Tamjeed Arshad, Rodney Samaan, David Jones, Dale Presser, John Heath, Sandy Green, George Bittar, Sheldon Henry, David Korn, John Schmedtje, Venkatesh Nadar, Bruce Graham, Ajay Labroo, Leonardo Clavijo, Hal Roseman, Gilbert Ledesma, Robert Rosen, Isaac Dor, William Kirby, Jennefer Sutton, Frank Eder, Bruce Iteld, Jose Gomez-Cortes, Maurice Buchbinder, Joseph Kasper, Antonio Terrelonge, Gustavo Torres, Ted Jagielo, Jose Alvarez, Yehuda Handelsman, Mario Guillen, Randall Richwine, Lorena Lewy-Alterbaum, Clinton Corder, Moogali Arvind, David Bolshoun, Magdy Mikhail, Stephen Minton, Odilon Alvarado, J Abbott, Brett Cauthen, Ryan Welter, Randy Mintz, John Cox, Annette Quick, Melvin Weiss, Johnny Dy, James Zebrack, Glenn Gandelman, Vinayak Hegde, Marc Silver, Michele DeGregorio, William Lawson, Christopher Paa, Anna Bortnick, Merrill Krolick, Rodolfo Sotolongo, Jorge Cheirif, Priya Kumar, Preetham Jetty, Ambar Patel, Mariusz Kruk, Iwona Kobielusz-Gembala, Barbara Rewerska, Adam Madrzejewski, Krzysztof Milewski, Jerzy Cygler, Joanna Petryka-Mazurkiewicz, Waldemar Jastrzebski, Janusz Korecki, Wojciech Fil, Janusz Prokopczuk, Anna Bochenek, Marek Wujkowski, Robert Witek, Piotr Konczakowski, Pawel Miekus, Marcin Szczasny, Wlodzimierz Musial, Krzysztof Cymerman, Jacek Lampart, Jacek Mikosinski, Slawomir Szynal, Issa Fares, Grzegorz Opolski, Stanislaw Mazur, Beata Wozakowska-Kaplon, Renata Bijata-Bronisz, Lukasz Wierucki, Beata Losa, Grzegorz Drelich, Marek Konieczny, Pawel Starczewski, Lidia Pawlowicz, Pawel Jesionowski, Jaroslaw Jurowiecki, Jacek Gniot, Mariusz Czyzycki, Karol Stania, Izabela Kucharczyk-Bauman, Benita Busz-Papiez, Agnieszka Karczmarczyk, Wanda Sudnik, Alina Koszek, Piotr Kolodziej, Bartosz Skwarna, Nicolás Jaramillo, Maciej Jankowski, Wojciech Czochra, Leszek Kinasz, Beata Miklaszewicz, Teresa Stasinska, Wladyslaw Pluta, Marcin Basiak, Teresa Rusicka, Izabela Niedbal-Yahfouf, Grazyna Popenda, Romuald Korzeniak, Agnieszka Mirek, Rafal Mariankowski, Lukasz Wojnowski, Marek Korol, Jacek Baszak, Piotr Podolec, Wojciech Piesiewicz, Aleksander Zurakowski, Carlos Luengas, Marek Skura, Piotr Pilecki, Piotr Majchrzak, Ewa Krzyzagórska, Marcin Drozd, Barbara Kaczmarek, Teresa Sliwinska, Katarzyna Zelazowska, Rafal Sztembis, Katarzyna Landa, Lidia Matyszczak-Toniak, Krzysztof Strojek, Marek Piepiorka, Robert Malinowski, Maria Górska, Edyta Stolarczyk-Sowa, Leszek Romanowski, Elzbieta Zinka, Zygfryd Reszka, Joanna Skierkowska, Anna Uzunow, Ewa Laskowska-Derlaga, Ekaterina Puntus, Elena D Kosmacheva, Natalia Koziolova, Prokhor Pavlov, Tatiana Supryadkina, Yury Didenko, Philipp Kopylov, Andrei Kazakov, Sergei Aksentiev, Elena Vishneva, Alexey Repin, Olga Smolenskaya, Olga Mantserova, Oleg Khrustalev, Elena Privalova, Vladimir Konstantinov, Svetlana Boldueva, Andrey Ezhov, Alexander Chernyavsky, Gadel Kamalov, Albert Galyavich, Galina Zubeeva, Galina Nechaeva, Sergey Shustov, Nino Dzhaiani, Tatiana Treshkur, Nataliya Osokina, Alexey Panov, Elena Shutemova, Valeriy Makukhin, Tatiana Kropotina, Larisa Tsyba, Yuri Karpov, J M Sizova, Marina Ballyuzek, Nikolay Tarasov, Elena Demchenko, Olga Barbarash, Valentin Moiseev, Valentin Markov, Vadim Kuznetsov, Inna Viktorova, Igor Sergienko, Lyudmila Ermoshkina, Niyaz Khasanov, Tatiana Khlevchuk, Andrey Baglikov, Sergey Shalaev, Elena Zonova, Elena Reznik, Larisa Haisheva, Tatyana Morugova, Nikita Lomakin, Alexander Vishnevsky, Yuri Shvarts, Olga Magnitskaya, Marina Mikhailusova, Elena Pavlysh, Igor Libov, Anna Zateyschikova, Victor Kostenko, Anton Edin, Yaroslava Khovaeva, Konstantin Zakharov, Raisa Stryuk, Vladimir Khirmanov, Sergey Kanorskiy, Sergey Yakushin, Anna Barabashkina, Hongwei Li, Qiang Zhao, Jian Zhang, Jianhua Ma, Yong He, Ming Luo, Aidong Zhang, Ningru Zhang, Yingru Chai, Genshan Ma, Hao Wang, Zhigang Liu, Lanjie He, Zhifang Song, Xiaolin Dong, Liang Tao, Zhanquan Li, Xi Su, Xiangqing Kong, Heping Niu, Junbo Ge, Zhurong Luo, Wenjun Huang, Daoquan Peng, Zuyi Yuan, Maria Milanova, Doncho Tenev, Antoni Gogov, Dimitar Karageorgiev, Todor Kolchev, Nikolay Rusev, Nikolina Georgieva, Rumen Kondov, Veselin Rusinov, Ivo Petrov, Georgi Stanchev, Mariana Konteva, Adriana Dincheva, Zdravka Yaneva, Ralitsa Vatova, Katya Ilieva, Nikolai Runev, Borislav Kolomanov, Ivan Petrov, Nikolay Iliev, Snezhanka Tisheva, Boryana Chompalova, Maria Tokmakova, Dimitar Raev, Kolyo Byanov, Dimitar Markov, Lenko Mihov, Atanas Mihov, Nora Milcheva, Milen Minchev, Mihail Mollov, Borislav Borisov, Tihomir Tihchev, Venelin Karakolev, Bojidar Dimov, Svetoslav Georgiev, Lachezar Smilov, Bon K Koo, Taehoon Ahn, Soon J Hong, Junghan Yoon, Seok K Oh, Myung H Jeong, Doo-Il Kim, Kiyuk Chang, Weon Kim, Joo-Yong Hahn, Kwang S Cha, Jung-Hee Lee, Si-Wan Choi, Chang-Wook Nam, In-Ho Chae, Yong H Park, Seung-Jea Tahk, Won-Yong Shin, Jei-Keon Chae, Byung J Kim, Jang-Whan Bae, Woo J Park, Seung W Rha, Young J Choi, Jin-Yong Hwang, Hun S Park, Luciano Baracioli, Fabio Guimaraes, Eduardo Vasconcellos, José Saraiva, Adamastor Pereira, Queulla Santos, Paulo Rossi, Lilia Maia, Miguel Madeira, Marcio Pereira, Roberto Botelho, Gilmar Reis, Freddy Eliaschewitz, Joao Borges, Carlos Nascimento, Jose A Fortes, Weimar de Souza, Pedro Pimentel, Miguel Hissa, Marcos Franchetti, Dalton Precoma, Costantino Ortiz, Mauro Hernandes, Wladmir Saporito, Fabio R dos Santos, Adrian Kormann, Fernando Neuenschwander, Oscar Dutra, Nelson Rassi, Luiz Tanajura, Juliana Souza, Delcio S Junior, Paulo Leaes, Adriana Forte, Teresa C Bonansea, Jose Marin, Bruno Machado, Maria J Cerqueira, Frederico Silva, Yorghos Michalaros, Euler Manenti, Cintia Cercato, Estevao Figueiredo, Ming-En Liu, Yi-Chih Wang, Tsung-Ming Lee, Chih Fang, Yen-Wen Wu, Kwo-Chang Ueng, Huey-Herng Sheu, Wen T Lai, I-Chang Hsieh, Zhih-Cherng Chen, Mu-Jang Lee, Chern Chiang, Kou-Gi Shyu, Chien-Hsun Hsia, Guang-Yuan Mar, Shih-Hung Chan, Chih-Cheng Wu, Wei-Kung Tseng, Kuan-Cheng Chang, Hung-I Yeh, Ji-Hung Wang, Charles Hou, Inna Sorokina, Maryna Dolzhenko, Olha Horoshko, Oleksandr Karpenko, Leonid Rudenko, Igor Vakaliuk, Anna Kulyk, Olena Levchenko, Oleksandr Prokhorov, Dmytro Reshotko, Mykhaylo Sorokivskyy, Nataliia Velichko, Valentyn Maslovskyi, Zinaida Teliatnikova, Sergiy Dotsenko, Olena Krakhmalova, Igor Kraiz, Viktoria Zharinova, Larysa Bula, Igor Kaydashev, Valeriy Molodtsov, Lesya Rasputina, Viktoriya Pidlisna, Olena Lysunets, Anatoliy Kravchenko, Liubomyr Glushko, Tetyana Khomazyuk, Yevgeniya Svyshchenko, Oleksandr Parkhomenko, Boris Mankovsky, Orest Abrahamovych, Andriy Yagensky, Mykola Stanislavchuk, Larisa Vasilyeva, Liubov Sokolova, Oleg Sychov, Vira Tseluyko, Igor Kyrychenko, Mykola Rishko, Sergiy Furkalo, Richard Gallo, Olivier Bertrand, Shamir Mehta, Christian Constance, Bruce Sussex, Remo Zadra, Simon Kouz, Raja Chehayeb, Amritanshu Pandey, Danielle Dion, Gordon Bailey, Laurie Hill, Krishnan Ramanathan, Micha Dorsch, Alykhan Nanji, Mohan Babapulle, Martine Montigny, Gilbert Gosselin, Payam Dehghani, Dennis Rupka, Michel Le May, Francis Pichette, Francois St-Maurice, Patrick Teefy, Samer Mansour, Saleem Kassam, Stephen Cheung, Anthony D Siega, Dennis O'Keefe, Eric Sabbah, Alan Bell, Guy Chouinard, Brian Wong, Mark Miller, Daniel Gaudet, Pierre Lachance, Iqbal Bata, Robert Petrella, Denis Gossard, Richard Dumas, Douglas Ing, Hagop Boyrazian, Ricardo Bessoudo, Thao T Huynh, Randy Hart, Jasmin Belle-Isle, Dinkar Shukla, Allan Kelly, Giuseppe Mazza, James Cha, Sam Henein, Andre Frechette, Saul Vizel, Joanne F Liutkus, Michael O'Mahony, Frank Halperin, Jacobus Kooy, John Graham, Allan Bailey, Ronald Wojcik, Igor Wilderman, Tibor Turi, Ákos Motyovszki, Béla Merkely, Csaba Király, Péter Andrássy, Zsolt Sárszegi, Tibor Fülöp, Zsolt Zilahi, István Édes, Andras Papp, Gábor Müller, Anna Czigány, Szilárd Zólyomi, László Korányi, János Takács, Ferenc Juhász, Bela Benczur, Sándor Kancz, András Földi, András C Nagy, Judit Bakai, István Greschik, László Püski, László Nagy, Róbert Kirschner, Roman Kuchar, Petr Hajek, Ladislav Busak, Daniel Michalik, Ivo Matyasek, Ivana Marusincova, Dusan Kucera, Ondrej Jerabek, Michaela Honkova, Vratislav Dedek, Ivan Rihacek, Pavel Kos, Josef Slaby, Martina Machkova, Eva Zidkova, Lubomir Elbl, Hana Grunfeldova, Jiri Carda, Vladimir Mrozek, Jiri Maly, Richard Milkovic, Jan Malecha, Hana Skalicka, Ivo Oral, Eva Krcova, Libor Lisa, Jan Belohlavek, Roman Miklik, Ondrej Cermak, Jana Bednarova, Zdenek Peroutka, Jindrich Spinar, Andreas Wilke, Karl-Friedrich Appel, Jens Taggeselle, Andreas Förster, Nicole Toursarkissian, Ekkehard Schmidt, Jochen Bott, Ayham Al-Zoebi, Dirk Hennig, Sabine Fischer, Norbert Schön, Joachim Sauter, Gregor Simonis, Ruth Nischik, Werner Rieker, Isabelle Schenkenberger, Thomas Behnke, Gerhard Klausmann, Michael Jeserich, Dietmar Trenk, Ingo Weigmann, Hannes Reuter, Reinhard Rummel, Candy von Münchhausen, Charlotte von Engelhardt, Eishun Horibe, Taro Shibasaki, Tomohiko Sato, Tsunekazu Kakuta, Ichiro Michishita, Michinao Tan, Ryoji Ishiki, Takahiko Aoyama, Shinichi Higashiue, Yawara Niijima, Akira Idogaki, Toru Hasegawa, Arihiro Kiyosue, Yoshiaki Tomobuchi, Katsunori Kawamitsu, Satsuki Kawasaki, Yoshiki Hata, Kazuki Fukui, Kozaburo Seki, Takashi Takenaka, Mitsuru Abe, Noriaki Utsu, Atsuyuki Oono, Kazuhisa Mitsuo, Atsushi Sueyoshi, Atsushi Hirohata, Mitsuru Tsujimoto, Osamu Ueda, Shinichi Takase, Masahiro Suzuki, Satoru Sakuragi, Fumi Yamamoto, Noritaka Fujimoto, Shigeo Kakinoki, Tatsushi Sugiura, Hiroshi Sugino, Toshihiro Nakamura, Toshiaki Kadokami, Hiroki Uehara, Masahiro Ono, Koichi Yokoya, Akihiro Koike, Sei Komatsu, Masahiro Sonoda, Hideki Ueno, Tomofumi Doi, Yuichiro Takagi, Kazuteru Fujimoto, Yutaka Eki, Munenori Okubo, Kenichiro Sasaki, Martijn van Eck, Eelko Ronner, Salem The, Ruud van de Wal, Pieter Nierop, Cornelis de Nooijer, Henri Werner, Iris Westendorp, Coen van der Zwaan, Hendrikus Crijns, Jan H Cornel, Sipke Strikwerda, Robert Bos, Edwin de Melker, Adrianus Kuijper, Hans Louwerenburg, Jacobus Plomp, Jan-Melle Dantzig, Francisco Prins, Henricus van Kesteren, Frank Willems, Giovanni Amoroso, Gabriela Carnero, Ernesto Duronto, Diego Besada, Carolina Chacon, Pedro Zangroniz, Silvana Solis, Alberto Liberman, Virginia Sernia, Andres Alvarisqueta, Laura Maffei, Oscar G Vilamajo, Celso García, Maximiliano Sicer, Juan Muntaner, Anselmo Bordonava, Juan Albisu, Alejandra Zanini, Lucas Rista, Miguel Hominal, José N Estrada, Aldo Prado, Diego M Gosparini, Beatriz Schiavi, Armando G Castillo, José G Ruíz, Guillermo R Martinez, Víctor G López, Enrique L Rosas, Gabriel R Lopez, Elias G Cantu, Manuel de los Ríos Ibarra, Francisco P Padilla, Jose P Carrasco, Luis V Carrillo, Joel D García, Alfredo N Askar, Carlos A Salinas, Marco A Gamba, Carlos G Sanchez, Arnulfo G Cantú, Raul V Sánchez, Jaime C Madrigal, Rafael H Urbano, Andrés Í Romo, José R González Juanatey, Paolo Racugno, Angel C Fillat, José M de la Torre Hernández, Juan A Peláez, Jorge B Cortada, Pablo G Pavia, Manuel J Navarro, Roberto M Asenjo, Francisco F Díaz, Eduard B Peligero, Fernando A Manterola, Antonio F Ortiz, Juan D Mediavilla García, Francisco M Ortuño, Tomás R Vera, Alfonso S González, Jaime A Viñas, Francisco J Fernández Portales, Petra S Mayordomo, Francisco B Ojeda, Antonio R Domínguez, Rosa S González, Diego B Guerrero, Juan M Ruiz Nodar, Xavier G Marimon, José G Margáez, Roberto M Aguilera, José F Díaz Fernández, José L Zamorano Gómez, Vicente B González, Bruno G del Blanco, Ignacio P Pérez, Mercé R Moreno, Ainhoa R Ereño, José A García Lledó, Juan Prieto, Alex Villablanca, Carlos Raffo, Christian Pincetti, Carlos Conejeros, Oscar Roman, Manuel Rodriguez, Paola Varleta, Cindy Goldberg, Jorge Sandoval, German Arriagada, Lucio Leon, Sergio Potthoff, Jorge Cobos, Christian Figueroa, Ellen Makotoko, Nyda Fourie, Lesley Burgess, Hendrik Nortje, Rust Theron, Perumal Pillai, Naresh Ranjith, Julien Trokis, Soobramoney Pillay, Jeevren Reddy, Theema Nunkoo, Cornelia Kapp, Dorothea Urbach, Lawrence Distiller, Adrian Horak, Louis van Zyl, Kathleen Coetzee, Zelda Punt, Junaid Bayat, 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Karol Micko, Juraj Palka Jr, Vladimir Sivak, Dalby Kristensen, Jens Refsgaard, Lene Holmvang, Ulrik Dixen, Henrik Nielsen, Kenneth Egstrup, Lisette O Jensen, Roman Sykulski, Ole Rasmussen, Alin Andries, Anders Luckow, Gitte Nielsen, Torben Sørensen, Chaiyasith Wongvipaporn, Noppadol Chamnarnphol, Suphot Srimahachota, Nakarin Sansanayudh, Srun Kuanprasert, Damras Tresukosol, Bancha Sookananchai, Mehmet Kanadasi, Turkay Ozcan, Murathan Kucuk, Zeki Ongen, Ertugrul Okuyan, Alev Arat, Sadik Acikel, Ahmet Yalcin, Umit Guray, Ceyhun Ceyhan, Necla Ozer, Sakir Arslan, Oskar Angerås, Nina Johnston, Ann-Charlotte Weiderman, Stellan Bandh, Ole Hansen, Hans Larnefeldt, Dawid Kusiak, Carl-Johan Lindholm, Anders Hedman, David Erlinge, Dan Curiac, Pia Lundman, Roberto Zucconi-Mazzini, Layth Aladellie, Jens Jensen, Jan Verwerft, Mathias Vrolix, Dirk Faes, Harry Striekwold, Peter Sinnaeve, Patrick Timmermans, Antoine Guedes, Marc Delforge, Jan Nimmegeers, Francis Stammen, Ian Buysschaert, Etienne Hoffer, Geert Hollanders, Geert Vervoort, Patrick Coussement, Stefan de Maeseneire, Luc Janssens, Stein A Gravdal, Knut Risberg, Lars Gullestad, Ola D Hofseth, Dennis Nilsen, Knut T Lappegård, Christian van den Heuvel, Charlotte Gibbs, Alamdar Khusrawi, Satish Arora, Tadeusz Tomala, Thorbjørn Kjærnli, Jan Berg-Johansen, Robert Hagemeier, Gunnar Skjelvan, David Colquhoun, John Amerena, Claire Morbey, Christopher Hammett, Anthony Dart, Ronald Lehman, Andrew Hamilton, Matthew Worthley, Peter Purnell, Alan Whelan, Richard MacIsaac, Ktut Arya, Sultan Linjawi, Joseph Proietto, Lakshman Prasad, Aldo Rodriguez, Armando Godoy, Victor Rodriguez, Percy Berrospi, Carlos Chavez, Sandra Negron, Javier Heredia, Felix Medina, Helard Manrique, Walter Cabrera, Fernando Cordova, Trinidad Quinteros, Jaime M Haro, Susana Regalado, Javier Guitton, Hugo Arbanil, Michel Pansieri, Eric Decoulx, Pascal Goube, Axel de Labriolle, Jean N Labeque, Gregoire Range, Yves Cottin, Gilles Montalescot, Guillaume Cayla, Nicolas Danchin, Denis Angoulvant, Emile Ferrario, Meyer Elbaz, Olivier Dubreuil, Philippe G Steg, Caroline Fontaine, Emmanuel Sorbets, Hafiz Omer, Shukri Al-Saif, Hussam Al-Faleh, Abdullah Al-Shehri, Halia Alshehri, Rasha Bazari, Pak Hei, Man Ying, Michael Chan, Michelle Wong, Ronald Ma, Shing C Siu, Chiu C Tsang, Maurizio Ferrario, Emilio Assanelli, Michele Senni, Piermarco Piatti, Paolo Calabrò, Stefano Urbinati, Massimo Michisanti, Ferdinando Varbella, Salvatore de Cosmo, Roberto Trevisan, Sandro Bellotti, Giuseppe Di Pasquale, Angelo S Bongo, Massimo Uguccioni, Edoardo Mannucci, Ciro Mauro, Mauro Ragonese, Claudio Fresco, Maurizio Turturo, Rossella Marcucci, Manuel J Lievano Triana, Camilo Arana, Jose Accini, Rodrigo Botero, Marlena Muzyk-Osikowicz, Fredy T Dada, Gregorio S Vallejo, Fernando Manzur, Daniel Isaza, Dora Molina, Juan G Mesa, Alvaro Quintero, Kai Nyman, Jyrki Mäkelä, Jorma Strand, Sakari Nieminen, Jyrki Taurio, Matti Kuusela, Timo Valle, Mikko Pietilä, Sakari Kekki, Timo Strandberg, Marc Klutstein, Gabriel Greenberg, Yoseph Rozenman, Ehud Chorin, Ariel Roguin, Basil Lewis, Amir Bashkin, Edgar Tan, Jose P Prado, Arthur Ferrolino, Noe Babilonia, Benny Barbas, Generoso Matiga, Raul M Coching, Heinz Drexel, Helmut Brath, Christoph Schnack, Ursula Hanusch, Evelyn Fließer-Görzer, Bernhard Paulweber, Christoph Ebenbichler, Rudolf Prager, Kurt Huber, Michael Wolzt, Johann Auer, Rudolf Berger, Gerit-Holger Schernthaner, Gabriela Stanciulescu, Mihai Creteanu, Marilena Spiridon, Viorica Dobreanu, Dragos Vinereanu, Laura C Iosipescu, Octavian Istratoaie, Ioan Coman, Constantin Militaru, Mircea Cinteza, Peter R Sinnaeve, José C Nicolau, José F Kerr Saraiva, Ramón Corbalán, Petr Widimský, Steen D Kristensen, Juha Hartikainen, Harald Darius, Hung F Tse, Robert G Kiss, Prem Pais, Eli Lev, Leonardo de Luca, Gabriel A Ramos López, Frederic Kontny, Noe A Babilonia, Dmitry A Zateyshchikov, Mikhail Ruda, Omer Elamin, František Kovář, Anthony J Dalby, Héctor Bueno, Chern-En Chiang, Alexander Parkhomenko, Tuan Q Nguyen, Maria Leonsson-Zachrisson, Herrada, Anthony, Brigham & Women’s Hospital [Boston] (BWH), Harvard Medical School [Boston] (HMS), AP-HP - Hôpital Bichat - Claude Bernard [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Laboratoire de Recherche Vasculaire Translationnelle (LVTS (UMR_S_1148 / U1148)), Université Paris 13 (UP13)-Université Paris Diderot - Paris 7 (UPD7)-Institut National de la Santé et de la Recherche Médicale (INSERM), Royal Brompton Hospital, McMaster University [Hamilton, Ontario], Keenan Research Centre of the Li Ka Shing Knowledge Institute [Toronto], St. Michael's Hospital, University of Toronto, Service de Pharmacologie médicale = service de pharmacologie - Dosage de médicaments [CHU Saint-Antoine], CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Sorbonne Université (SU), National Heart and Lung Institute [London] (NHLI), Imperial College London-Royal Brompton and Harefield NHS Foundation Trust, Uppsala University Hospital, Uppsala Universitet [Uppsala], AstraZeneca, Tokai University, Uppsala University, Imperial College London, Saint Luke's Mid America Heart Institute, University of Missouri [Kansas City] (UMKC), University of Missouri System, University of New South Wales [Sydney] (UNSW), University of Texas Southwestern Medical Center [Dallas], Stanford University, Centre Hospitalier Universitaire de Nîmes (CHU Nîmes), Université de Montpellier (UM), Bhatt, D, Steg, P, Mehta, S, Leiter, L, Simon, T, Fox, K, Held, C, Andersson, M, Himmelmann, A, Ridderstrale, W, Chen, J, Song, Y, Diaz, R, Goto, S, James, S, Ray, K, Parkhomenko, A, Kosiborod, M, Mcguire, D, Harrington, R, Santos, V, Jain, A, Lendel, I, Russo, M, Haught, W, Bouza, M, Gogia, H, Banerjee, S, Kichura, G, Kantaros, L, Padron, F, Passi, R, Stone, J, Pursley, M, D'Urso, M, Gardner, T, Bennett, J, Nour, K, Saini, S, Zhang, W, Kumbhani, D, Thomas, D, Angiolillo, D, Bertolet, B, Roman-Miranda, A, Black, R, Manshadi, R, Vaca, C, Blanco, A, Napoli, M, Brabham, D, Akyea-Djamson, A, Desai, P, Prasada, S, Khaira, A, Forgosh, L, Lieber, I, Umpierrez, G, Singal, D, Londono, J, Fraser, N, Ruiz, J, Vega, D, Rodriguez, L, Brown, C, Syed, F, Aggarwala, G, Eaves, W, Foster, M, Gupta, D, Avino, D, Asfour, W, Tonnessen, G, Zhao, X, Singh, N, Brockmyre, A, Lepor, N, Shammas, N, Blick, D, Hearne, S, Prodafikas, J, Carell, E, Izzo, M, Karim, A, Zakhary, B, Atieh, M, Leichter, S, Meadows, C, Hotchkiss, D, Abu-Fadel, M, Wiseman, A, Bander, J, Shah, M, Ganim, R, Sopko, K, Khan, M, Lloret, R, Weirick, T, Mehta, R, Thadani, U, Bhargava, A, Moya, J, Staniloae, C, Guerra, Y, Chhabra, A, Kosmicki, D, Shaheen, W, Mohammed, A, Bitters, J, Pattanayak, J, Javier, J, Srivastava, S, Phillips, R, Al-Amin, J, Lillestol, M, Simpson, P, Hazan, L, Amin, A, Shah, G, Korpas, D, Platt, B, Dickert, J, Puente, O, Hiotis, L, Doyle, T, Rajan, R, Meholick, A, Gring, C, Hage-Korban, E, Feldman, R, Colfer, H, Butman, S, Hart, T, Huling, R, Eshaghian, S, Quintana, O, Cheung, D, Handel, F, Rodriguez, M, Suh, D, Gordon, P, Pressman, G, Bauer, M, French, W, Barettella, M, Chatrathi, S, Suresh, D, Goldberg, R, Huth, M, Younis, L, Rahman, A, Mascolo, R, Welch, M, Suneja, R, Smith, S, Shurmur, S, Agaiby, J, Jingo, A, Johnston, J, Beth, M, Vlastaris, A, Kemp, S, Taheri, H, Pereira, E, Deyoung, M, Hawa, Z, Smith, R, Galski, T, Garas, S, Reddy, M, Sharma, S, Hargrove, J, Treasure, C, Emerson, R, Haddad, T, Rohr, K, Levinson, L, Gaona, R, Uretsky, B, Maheshwari, H, Lee, D, Kinnaman, S, Singal, R, Geohas, J, Gigliotti, O, Raisinghani, A, Khurana, C, Hella, B, Kelberman, M, Voyce, S, Singh, S, Lo, E, Singh, P, Goodfellow, R, Fischer, S, Lorraine, R, Turner, T, Shanes, J, Busch, R, Broker, R, Zaniewski, M, Pounds, K, Debs-Perez, G, Ong, S, Frandsen, B, Fullington, D, Jaffrani, N, Khan, A, Lee, M, Pouzar, J, Revtyak, G, Gonzalez, J, Nakhle, S, Murillo, A, Young, D, Makam, S, Syed, M, Woolf, K, Grena, P, Alfata, S, Mahal, S, Hoffman, D, Kizhakekuttu, T, Deering, J, Bhavsar, J, Mikesell, S, Wilson, W, Wilson, V, El, S, Spinale, F, Kannarkat, V, Rao, S, Hanson, L, Bertsch, J, Gonzalez-Ortiz, E, Severino, N, Willis, J, Schock, J, Bakhtari, L, Gazmuri, R, Ansari, S, Hall, J, Mehta, A, Shealy, N, Zarich, S, Singh, D, Vora, K, Andrawis, N, Molter, D, Maron, D, Cardona, J, D'Agostino, R, Arshad, T, Samaan, R, Jones, D, Presser, D, Heath, J, Green, S, Bittar, G, Henry, S, Korn, D, Schmedtje, J, Nadar, V, Graham, B, Labroo, A, Clavijo, L, Roseman, H, Ledesma, G, Rosen, R, Dor, I, Kirby, W, Sutton, J, Eder, F, Iteld, B, Gomez-Cortes, J, Buchbinder, M, Kasper, J, Terrelonge, A, Torres, G, Jagielo, T, Alvarez, J, Handelsman, Y, Guillen, M, Richwine, R, Lewy-Alterbaum, L, Corder, C, Arvind, M, Bolshoun, D, Mikhail, M, Minton, S, Alvarado, O, Abbott, J, Cauthen, B, Welter, R, Mintz, R, Cox, J, Quick, A, Weiss, M, Dy, J, Zebrack, J, Gandelman, G, Hegde, V, Silver, M, Degregorio, M, Lawson, W, Paa, C, Bortnick, A, Krolick, M, Sotolongo, R, Cheirif, J, Kumar, P, Jetty, P, Patel, A, Kruk, M, Kobielusz-Gembala, I, Rewerska, B, Madrzejewski, A, Milewski, K, Cygler, J, Petryka-Mazurkiewicz, J, Jastrzebski, W, Korecki, J, Fil, W, Prokopczuk, J, Bochenek, A, Wujkowski, M, Witek, R, Konczakowski, P, Miekus, P, Szczasny, M, Musial, W, Cymerman, K, Lampart, J, Mikosinski, J, Szynal, S, Fares, I, Opolski, G, Mazur, S, Wozakowska-Kaplon, B, Bijata-Bronisz, R, Wierucki, L, Losa, B, Drelich, G, Konieczny, M, Starczewski, P, Pawlowicz, L, Jesionowski, P, Jurowiecki, J, Gniot, J, Czyzycki, M, Stania, K, Kucharczyk-Bauman, I, Busz-Papiez, B, Karczmarczyk, A, Sudnik, W, Koszek, A, Kolodziej, P, Skwarna, B, Jaramillo, N, Jankowski, M, Czochra, W, Kinasz, L, Miklaszewicz, B, Stasinska, T, Pluta, W, Basiak, M, Rusicka, T, Niedbal-Yahfouf, I, Popenda, G, Korzeniak, R, Mirek, A, Mariankowski, R, Wojnowski, L, Korol, M, Baszak, J, Podolec, P, Piesiewicz, W, Zurakowski, A, Luengas, C, Skura, M, Pilecki, P, Majchrzak, P, Krzyzagorska, E, Drozd, M, Kaczmarek, B, Sliwinska, T, Zelazowska, K, Sztembis, R, Landa, K, Matyszczak-Toniak, L, Strojek, K, Piepiorka, M, Malinowski, R, Gorska, M, Stolarczyk-Sowa, E, Romanowski, L, Zinka, E, Reszka, Z, Skierkowska, J, Uzunow, A, Laskowska-Derlaga, E, Puntus, E, Kosmacheva, E, Koziolova, N, Pavlov, P, Supryadkina, T, Didenko, Y, Kopylov, P, Kazakov, A, Aksentiev, S, Vishneva, E, Repin, A, Smolenskaya, O, Mantserova, O, Khrustalev, O, Privalova, E, Konstantinov, V, Boldueva, S, Ezhov, A, Chernyavsky, A, Kamalov, G, Galyavich, A, Zubeeva, G, Nechaeva, G, Shustov, S, Dzhaiani, N, Treshkur, T, Osokina, N, Panov, A, Shutemova, E, Makukhin, V, Kropotina, T, Tsyba, L, Karpov, Y, Sizova, J, Ballyuzek, M, Tarasov, N, Demchenko, E, Barbarash, O, Moiseev, V, Markov, V, Kuznetsov, V, Viktorova, I, Sergienko, I, Ermoshkina, L, Khasanov, N, Khlevchuk, T, Baglikov, A, Shalaev, S, Zonova, E, Reznik, E, Haisheva, L, Morugova, T, Lomakin, N, Vishnevsky, A, Shvarts, Y, Magnitskaya, O, Mikhailusova, M, Pavlysh, E, Libov, I, Zateyschikova, A, Kostenko, V, Edin, A, Khovaeva, Y, Zakharov, K, Stryuk, R, Khirmanov, V, Kanorskiy, S, Yakushin, S, Barabashkina, A, Li, H, Zhao, Q, Zhang, J, Ma, J, He, Y, Luo, M, Zhang, A, Zhang, N, Chai, Y, Ma, G, Wang, H, Liu, Z, He, L, Song, Z, Dong, X, Tao, L, Li, Z, Su, X, Kong, X, Niu, H, Ge, J, Luo, Z, Huang, W, Peng, D, Yuan, Z, Milanova, M, Tenev, D, Gogov, A, Karageorgiev, D, Kolchev, T, Rusev, N, Georgieva, N, Kondov, R, Rusinov, V, Petrov, I, Stanchev, G, Konteva, M, Dincheva, A, Yaneva, Z, Vatova, R, Ilieva, K, Runev, N, Kolomanov, B, Iliev, N, Tisheva, S, Chompalova, B, Tokmakova, M, Raev, D, Byanov, K, Markov, D, Mihov, L, Mihov, A, Milcheva, N, Minchev, M, Mollov, M, Borisov, B, Tihchev, T, Karakolev, V, Dimov, B, Georgiev, S, Smilov, L, Koo, B, Ahn, T, Hong, S, Yoon, J, Oh, S, Jeong, M, Kim, D, Chang, K, Kim, W, Hahn, J, Cha, K, Lee, J, Choi, S, Nam, C, Chae, I, Park, Y, Tahk, S, Shin, W, Chae, J, Kim, B, Bae, J, Park, W, Rha, S, Choi, Y, Hwang, J, Park, H, Baracioli, L, Guimaraes, F, Vasconcellos, E, Saraiva, J, Pereira, A, Santos, Q, Rossi, P, Maia, L, Madeira, M, Pereira, M, Botelho, R, Reis, G, Eliaschewitz, F, Borges, J, Nascimento, C, Fortes, J, de Souza, W, Pimentel, P, Hissa, M, Franchetti, M, Precoma, D, Ortiz, C, Hernandes, M, Saporito, W, dos Santos, F, Kormann, A, Neuenschwander, F, Dutra, O, Rassi, N, Tanajura, L, Souza, J, Junior, D, Leaes, P, Forte, A, Bonansea, T, Marin, J, Machado, B, Cerqueira, M, Silva, F, Michalaros, Y, Manenti, E, Cercato, C, Figueiredo, E, Liu, M, Wang, Y, Lee, T, Fang, C, Wu, Y, Ueng, K, Sheu, H, Lai, W, Hsieh, I, Chen, Z, Chiang, C, Shyu, K, Hsia, C, Mar, G, Chan, S, Wu, C, Tseng, W, Yeh, H, Wang, J, Hou, C, Sorokina, I, Dolzhenko, M, Horoshko, O, Karpenko, O, Rudenko, L, Vakaliuk, I, Kulyk, A, Levchenko, O, Prokhorov, O, Reshotko, D, Sorokivskyy, M, Velichko, N, Maslovskyi, V, Teliatnikova, Z, Dotsenko, S, Krakhmalova, O, Kraiz, I, Zharinova, V, Bula, L, Kaydashev, I, Molodtsov, V, Rasputina, L, Pidlisna, V, Lysunets, O, Kravchenko, A, Glushko, L, Khomazyuk, T, Svyshchenko, Y, Parkhomenko, O, Mankovsky, B, Abrahamovych, O, Yagensky, A, Stanislavchuk, M, Vasilyeva, L, Sokolova, L, Sychov, O, Tseluyko, V, Kyrychenko, I, Rishko, M, Furkalo, S, Gallo, R, Bertrand, O, Constance, C, Sussex, B, Zadra, R, Kouz, S, Chehayeb, R, Pandey, A, Dion, D, Bailey, G, Hill, L, Ramanathan, K, Dorsch, M, Nanji, A, Babapulle, M, Montigny, M, Gosselin, G, Dehghani, P, Rupka, D, Le May, M, Pichette, F, St-Maurice, F, Teefy, P, Mansour, S, Kassam, S, Cheung, S, Siega, A, O'Keefe, D, Sabbah, E, Bell, A, Chouinard, G, Wong, B, Miller, M, Gaudet, D, Lachance, P, Bata, I, Petrella, R, Gossard, D, Dumas, R, Ing, D, Boyrazian, H, Bessoudo, R, Huynh, T, Hart, R, Belle-Isle, J, Shukla, D, Kelly, A, Mazza, G, Cha, J, Henein, S, Frechette, A, Vizel, S, Liutkus, J, O'Mahony, M, Halperin, F, Kooy, J, Graham, J, Bailey, A, Wojcik, R, Wilderman, I, Turi, T, Motyovszki, A, Merkely, B, Kiss, R, Kiraly, C, Andrassy, P, Sarszegi, Z, Fulop, T, Zilahi, Z, Edes, I, Papp, A, Muller, G, Czigany, A, Zolyomi, S, Koranyi, L, Takacs, J, Juhasz, F, Benczur, B, Kancz, S, Foldi, A, Nagy, A, Bakai, J, Greschik, I, Puski, L, Nagy, L, Kirschner, R, Kuchar, R, Hajek, P, Busak, L, Michalik, D, Matyasek, I, Marusincova, I, Kucera, D, Jerabek, O, Honkova, M, Dedek, V, Rihacek, I, Kos, P, Slaby, J, Machkova, M, Zidkova, E, Elbl, L, Grunfeldova, H, Carda, J, Mrozek, V, Maly, J, Milkovic, R, Malecha, J, Skalicka, H, Oral, I, Krcova, E, Lisa, L, Belohlavek, J, Miklik, R, Cermak, O, Bednarova, J, Peroutka, Z, Spinar, J, Wilke, A, Appel, K, Taggeselle, J, Forster, A, Toursarkissian, N, Schmidt, E, Bott, J, Al-Zoebi, A, Hennig, D, Schon, N, Sauter, J, Simonis, G, Nischik, R, Rieker, W, Schenkenberger, I, Behnke, T, Klausmann, G, Jeserich, M, Trenk, D, Weigmann, I, Reuter, H, Rummel, R, von Munchhausen, C, von Engelhardt, C, Horibe, E, Shibasaki, T, Sato, T, Kakuta, T, Michishita, I, Tan, M, Ishiki, R, Aoyama, T, Higashiue, S, Niijima, Y, Idogaki, A, Hasegawa, T, Kiyosue, A, Tomobuchi, Y, Kawamitsu, K, Kawasaki, S, Hata, Y, Fukui, K, Seki, K, Takenaka, T, Abe, M, Utsu, N, Oono, A, Mitsuo, K, Sueyoshi, A, Hirohata, A, Tsujimoto, M, Ueda, O, Takase, S, Suzuki, M, Sakuragi, S, Yamamoto, F, Fujimoto, N, Kakinoki, S, Sugiura, T, Sugino, H, Nakamura, T, Kadokami, T, Uehara, H, Ono, M, Yokoya, K, Koike, A, Komatsu, S, Sonoda, M, Ueno, H, Doi, T, Takagi, Y, Fujimoto, K, Eki, Y, Okubo, M, Sasaki, K, van Eck, M, Ronner, E, The, S, van de Wal, R, Nierop, P, de Nooijer, C, Werner, H, Westendorp, I, van der Zwaan, C, Crijns, H, Cornel, J, Strikwerda, S, Bos, R, de Melker, E, Kuijper, A, Louwerenburg, H, Plomp, J, Dantzig, J, Prins, F, van Kesteren, H, Willems, F, Amoroso, G, Carnero, G, Duronto, E, Besada, D, Chacon, C, Zangroniz, P, Solis, S, Liberman, A, Sernia, V, Alvarisqueta, A, Maffei, L, Vilamajo, O, Garcia, C, Sicer, M, Muntaner, J, Bordonava, A, Albisu, J, Zanini, A, Rista, L, Hominal, M, Estrada, J, Prado, A, Gosparini, D, Schiavi, B, Castillo, A, Martinez, G, Lopez, V, Rosas, E, Lopez, G, Cantu, E, de los Rios Ibarra, M, Padilla, F, Carrasco, J, Carrillo, L, Garcia, J, Askar, A, Salinas, C, Gamba, M, Sanchez, C, Cantu, A, Sanchez, R, Madrigal, J, Urbano, R, Romo, A, Gonzalez Juanatey, J, Racugno, P, Fillat, A, de la Torre Hernandez, J, Pelaez, J, Cortada, J, Pavia, P, Navarro, M, Asenjo, R, Diaz, F, Peligero, E, Manterola, F, Ortiz, A, Mediavilla Garcia, J, Ortuno, F, Vera, T, Gonzalez, A, Vinas, J, Fernandez Portales, F, Mayordomo, P, Ojeda, F, Dominguez, A, Gonzalez, R, Guerrero, D, Ruiz Nodar, J, Marimon, X, Margaez, J, Aguilera, R, Diaz Fernandez, J, Zamorano Gomez, J, Gonzalez, V, del Blanco, B, Perez, I, Moreno, M, Ereno, A, Garcia Lledo, J, Prieto, J, Villablanca, A, Raffo, C, Pincetti, C, Conejeros, C, Roman, O, Varleta, P, Goldberg, C, Sandoval, J, Arriagada, G, Corbalan, R, Leon, L, Potthoff, S, Cobos, J, Figueroa, C, Makotoko, E, Fourie, N, Burgess, L, Nortje, H, Theron, R, Pillai, P, Ranjith, N, Trokis, J, Pillay, S, Reddy, J, Nunkoo, T, Kapp, C, Urbach, D, Distiller, L, Horak, A, van Zyl, L, Coetzee, K, Punt, Z, Bayat, J, Dawood, S, Mitha, I, Padayachee, T, Hoosen, F, Dalby, A, Prabhavathi, Gowdaiah, P, Mehta, V, Chag, M, Gadkari, M, Ramamurthee, K, Das, A, Sawhney, J, Sathe, P, Adhyapak, S, Nguyen, T, Pham, V, Do, H, Nguyen, A, Nguyen, H, Truong, B, Jamil-Copley, S, Lang, C, Pell, A, Zaman, A, Storey, R, Swanson, N, Sharman, D, Braganza, D, Hammond, P, Moriarty, A, Bain, S, Pye, M, Sharp, A, Blagden, M, Randeva, H, Myhill, T, Viswanathan, G, Keeling, P, Clifford, P, Saxena, M, Lyons, K, Mcmurray, J, Jaafar, F, Murphy, C, Cartwright, S, Abouglila, K, Antalik, L, Krajci, P, Urban, M, Fazekas, F, Pella, D, Koleny, D, Vykoukalova, T, Macek, V, Vinanska, D, Jamriskova, L, Such, S, Fulop, P, Farsky, S, Bugan, V, Strbova, J, Micko, K, Palka Jr, J, Sivak, V, Kristensen, D, Refsgaard, J, Holmvang, L, Dixen, U, Nielsen, H, Egstrup, K, Jensen, L, Sykulski, R, Rasmussen, O, Andries, A, Luckow, A, Nielsen, G, Sorensen, T, Wongvipaporn, C, Chamnarnphol, N, Srimahachota, S, Sansanayudh, N, Kuanprasert, S, Tresukosol, D, Sookananchai, B, Kanadasi, M, Ozcan, T, Kucuk, M, Ongen, Z, Okuyan, E, Arat, A, Acikel, S, Yalcin, A, Guray, U, Ceyhan, C, Ozer, N, Arslan, S, Angeras, O, Johnston, N, Weiderman, A, Bandh, S, Hansen, O, Larnefeldt, H, Kusiak, D, Lindholm, C, Hedman, A, Erlinge, D, Curiac, D, Lundman, P, Zucconi-Mazzini, R, Aladellie, L, Jensen, J, Verwerft, J, Vrolix, M, Faes, D, Striekwold, H, Sinnaeve, P, Timmermans, P, Guedes, A, Delforge, M, Nimmegeers, J, Stammen, F, Buysschaert, I, Hoffer, E, Hollanders, G, Vervoort, G, Coussement, P, de Maeseneire, S, Janssens, L, Gravdal, S, Risberg, K, Gullestad, L, Hofseth, O, Nilsen, D, Lappegard, K, van den Heuvel, C, Gibbs, C, Khusrawi, A, Arora, S, Tomala, T, Kjaernli, T, Berg-Johansen, J, Hagemeier, R, Skjelvan, G, Colquhoun, D, Amerena, J, Morbey, C, Hammett, C, Dart, A, Lehman, R, Hamilton, A, Worthley, M, Purnell, P, Whelan, A, Macisaac, R, Arya, K, Linjawi, S, Proietto, J, Prasad, L, Rodriguez, A, Godoy, A, Rodriguez, V, Berrospi, P, Chavez, C, Negron, S, Heredia, J, Medina, F, Manrique, H, Cabrera, W, Cordova, F, Quinteros, T, Haro, J, Regalado, S, Guitton, J, Arbanil, H, Pansieri, M, Decoulx, E, Goube, P, de Labriolle, A, Labeque, J, Range, G, Cottin, Y, Montalescot, G, Cayla, G, Danchin, N, Angoulvant, D, Ferrario, E, Elbaz, M, Dubreuil, O, Fontaine, C, Sorbets, E, Omer, H, Al-Saif, S, Al-Faleh, H, Al-Shehri, A, El-Amin, O, Alshehri, H, Bazari, R, Hei, P, Ying, M, Chan, M, Wong, M, Ma, R, Siu, S, Tsang, C, Ferrario, M, Assanelli, E, Senni, M, Piatti, P, Calabro, P, Urbinati, S, Michisanti, M, Varbella, F, de Cosmo, S, Trevisan, R, Bellotti, S, Di Pasquale, G, Bongo, A, Uguccioni, M, Mannucci, E, Mauro, C, Ragonese, M, Fresco, C, Turturo, M, Marcucci, R, Lievano Triana, M, Arana, C, Accini, J, Botero, R, Muzyk-Osikowicz, M, Dada, F, Vallejo, G, Manzur, F, Isaza, D, Molina, D, Mesa, J, Quintero, A, Nyman, K, Makela, J, Strand, J, Nieminen, S, Taurio, J, Kuusela, M, Valle, T, Pietila, M, Kekki, S, Strandberg, T, Klutstein, M, Greenberg, G, Rozenman, Y, Chorin, E, Roguin, A, Lewis, B, Bashkin, A, Tan, E, Prado, J, Ferrolino, A, Babilonia, N, Barbas, B, Matiga, G, Coching, R, Drexel, H, Brath, H, Schnack, C, Hanusch, U, Fliesser-Gorzer, E, Paulweber, B, Ebenbichler, C, Prager, R, Huber, K, Wolzt, M, Auer, J, Berger, R, Schernthaner, G, Stanciulescu, G, Creteanu, M, Spiridon, M, Dobreanu, V, Vinereanu, D, Iosipescu, L, Istratoaie, O, Coman, I, Militaru, C, Cinteza, M, Nicolau, J, Kerr Saraiva, J, Widimsky, P, Kristensen, S, Hartikainen, J, Darius, H, Tse, H, Pais, P, Lev, E, de Luca, L, Ramos Lopez, G, Kontny, F, Zateyshchikov, D, Ruda, M, Elamin, O, Kovar, F, Bueno, H, Leonsson-Zachrisson, M, Université Paris Diderot - Paris 7 (UPD7)-Université Paris 13 (UP13)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service de pharmacologie - Dosage de médicaments [CHU Saint-Antoine], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU), and Royal Brompton and Harefield NHS Foundation Trust-Imperial College London
Subjects: Male, Platelet Aggregation Inhibitors/therapeutic use, THEMIS Steering Committee and Investigators, medicine.medical_treatment, Vascular damage Radboud Institute for Health Sciences [Radboudumc 16], 030204 cardiovascular system & hematology, Coronary Angiography, Stroke/epidemiology, Coronary artery disease, DOUBLE-BLIND, 0302 clinical medicine, Hemorrhage/chemically induced, acetylsalicylic acid, antidiabetic agent, placebo, ticagrelor, Secondary Prevention, Medicine, 030212 general & internal medicine, Myocardial infarction, Coronary Artery Bypass, Cardiovascular Diseases/mortality, 11 Medical and Health Sciences, OUTCOMES, Aspirin, [SDV.MHEP] Life Sciences [q-bio]/Human health and pathology, General Medicine, Middle Aged, Clopidogrel, 3. Good health, Ticagrelor/therapeutic use, DRUG-ELUTING STENTS, CLOPIDOGREL, Cardiology, PLATELET INHIBITION, Drug Therapy, Combination, Female, Life Sciences & Biomedicine, Ticagrelor, TIMI, medicine.drug, Coronary Artery Disease/complications, medicine.medical_specialty, Hypoglycemic Agents/therapeutic use, POOLED ANALYSIS, 03 medical and health sciences, Medicine, General & Internal, Percutaneous Coronary Intervention, Double-Blind Method, General & Internal Medicine, Internal medicine, Myocardial Infarction/epidemiology, Humans, Aged, Science & Technology, ANTIPLATELET THERAPY, business.industry, Diabetes Mellitus, Type 2/complications, ELEVATION MYOCARDIAL-INFARCTION, RIVAROXABAN, Percutaneous coronary intervention, medicine.disease, ASPIRIN, Coronary Stenosis/diagnostic imaging, Aspirin/therapeutic use, Conventional PCI, business, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract: Contains fulltext : 215333.pdf (Publisher’s version ) (Closed access) BACKGROUND: Patients with stable coronary artery disease and diabetes with previous percutaneous coronary intervention (PCI), particularly those with previous stenting, are at high risk of ischaemic events. These patients are generally treated with aspirin. In this trial, we aimed to investigate if these patients would benefit from treatment with aspirin plus ticagrelor. METHODS: The Effect of Ticagrelor on Health Outcomes in diabEtes Mellitus patients Intervention Study (THEMIS) was a phase 3 randomised, double-blinded, placebo-controlled trial, done in 1315 sites in 42 countries. Patients were eligible if 50 years or older, with type 2 diabetes, receiving anti-hyperglycaemic drugs for at least 6 months, with stable coronary artery disease, and one of three other mutually non-exclusive criteria: a history of previous PCI or of coronary artery bypass grafting, or documentation of angiographic stenosis of 50% or more in at least one coronary artery. Eligible patients were randomly assigned (1:1) to either ticagrelor or placebo, by use of an interactive voice-response or web-response system. The THEMIS-PCI trial comprised a prespecified subgroup of patients with previous PCI. The primary efficacy outcome was a composite of cardiovascular death, myocardial infarction, or stroke (measured in the intention-to-treat population). FINDINGS: Between Feb 17, 2014, and May 24, 2016, 11 154 patients (58% of the overall THEMIS trial) with a history of previous PCI were enrolled in the THEMIS-PCI trial. Median follow-up was 3.3 years (IQR 2.8-3.8). In the previous PCI group, fewer patients receiving ticagrelor had a primary efficacy outcome event than in the placebo group (404 [7.3%] of 5558 vs 480 [8.6%] of 5596; HR 0.85 [95% CI 0.74-0.97], p=0.013). The same effect was not observed in patients without PCI (p=0.76, pinteraction=0.16). The proportion of patients with cardiovascular death was similar in both treatment groups (174 [3.1%] with ticagrelor vs 183 (3.3%) with placebo; HR 0.96 [95% CI 0.78-1.18], p=0.68), as well as all-cause death (282 [5.1%] vs 323 [5.8%]; 0.88 [0.75-1.03], p=0.11). TIMI major bleeding occurred in 111 (2.0%) of 5536 patients receiving ticagrelor and 62 (1.1%) of 5564 patients receiving placebo (HR 2.03 [95% CI 1.48-2.76], p
Published: 2019

45. A 10-year follow-up study of demographic and cardiometabolic factors in HIV-infected South Africans

Author: Phalane, Edith, Fourie, Carla Maria Theresia, Mels, Catharina Martha Cornelia, Schutte, Aletta Elisabeth, 10922180 - Schutte, Aletta Elisabeth, 12076341 - Mels, Catharina Martha Cornelia, 10062491 - Fourie, Catharina Maria Theresia, and 28149866 - Phalane, Edith
Subjects: medicine.medical_specialty, Human immunodeficiency virus (HIV), Renal function, Inflammation, Disease, 030204 cardiovascular system & hematology, medicine.disease_cause, Gastroenterology, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Internal medicine, medicine, Triglyceride, biology, business.industry, Mortality rate, Cardiovascular Topics, General Medicine, chemistry, Alanine transaminase, biology.protein, Liver function, medicine.symptom, Cardiology and Cardiovascular Medicine, business
Abstract: OBJECTIVES: Understanding of the interplay between human immunodeficiency virus (HIV) and cardiovascular disease, especially in Africa, is limited to evidence from longitudinal studies. Therefore the demographic profile and cardiometabolic, renal and liver function of an HIV-infected South African population were profiled from 2005 to 2015. METHODS: The study included 117 HIV-infected and 131 uninfected controls that were examined at baseline, five and 10 years. RESULTS: Mortality rate declined from 24% (2005–2010) to 0% (2010–2015) after the introduction of ART. Longitudinal increases in C-reactive protein (p = 0.002), alanine transaminase (p = 0.006) and gamma-glutamyl transferase (p = 0.046) levels and estimated glomerular filtration rate (p < 0.001) were seen only in the HIV-infected group. This group also showed increased high-density lipoprotein cholesterol (HDL-C) (p < 0.001) and total cholesterol (p < 0.001) levels and decreased triglyceride:HDL-C (p = 0.011) levels. Low-density lipoprotein cholesterol decreased in both groups (p < 0.001). CONCLUSION: Despite trajectories of deranged lipid and inflammatory profiles, the cardiometabolic disease risk seems stable in HIV-infected South Africans. Inflammation and renal and liver function warrant regular monitoring.
Published: 2019

46. The African prospective study on the early detection and identification of cardiovascular disease and hypertension (African-PREDICT): design, recruitment and initial examination

Author: Leandi Lammertyn, Gontse G. Mokwatsi, Shani Botha, Hugo W. Huisman, Tertia van Zyl, Itumeleng P. Khumalo, Yolandi Breet, Marlien Pieters, Aletta S. Uys, Johannes M. Van Rooyen, Roan Louw, Christian Delles, Wayne Smith, Lizelle Zandberg, Carla M.T. Fourie, Lebo F. Gafane-Matemane, Sarah J. Moss, Catharina M. C. Mels, Philimon Gona, H. Salome Kruger, Ruan Kruger, Adele Burger, Aletta E. Schutte, 10922180 - Schutte, Aletta Elisabeth, 20030223 - Uys, Aletta Sophia, 10677402 - Burger, Adele, 12076341 - Mels, Catharina Martha Cornelia, 10210407 - Moss, Sarah Johanna, 20035632 - Kruger, Ruan, 22945717 - Smith, Wayne, 10062491 - Fourie, Catharina Maria Theresia, 20695241 - Botha, Shani, 20088310 - Lammertyn, Leandi, 10059539 - Van Rooyen, Johannes Marthinus, 24341185 - Gafane-Matemane, Lebo Francina, 22368590 - Mokwatsi, Gontse Gratitude, 21195706 - Breet, Yolandi, 10061568 - Kruger, Herculina Salome, 10795626 - Van Zyl, Tertia, 10797920 - Pieters, Marlien, 12257656 - Zandberg, Lizelle, 10986707 - Louw, Roan, and 10062718 - Huisman, Hugo Willem
Subjects: Male, Time Factors, Epidemiology, Blood Pressure, Disease, 030204 cardiovascular system & hematology, Full Research Paper, South Africa, 0302 clinical medicine, Risk Factors, Ethnicity, 030212 general & internal medicine, Longitudinal Studies, Prospective Studies, Prospective cohort study, race, Incidence (epidemiology), Cohort, cohort, Organ damage, Prognosis, Cardiovascular Diseases, Research Design, Black, Hypertension, ethnicity, Female, Cardiology and Cardiovascular Medicine, Adult, medicine.medical_specialty, Race, longitudinal, organ damage, Young, Early detection, Black People, Risk Assessment, White People, 03 medical and health sciences, Young Adult, black, medicine, Humans, Intensive care medicine, African-PREDICT, young, business.industry, Patient Selection, biomarkers, Blood pressure, Early Diagnosis, Africa, Longitudinal, business, Biomarkers
Abstract: Background Globally hypertension is stabilising, but in sub-Saharan Africa the incidence of hypertension remains on an increase. Although this might be attributed to poor healthcare and ineffective antihypertensive treatment, there is a limited understanding of population and individual-specific cardiovascular pathophysiology – necessary for effective prevention and treatment strategies in Africa. As there is a lack of longitudinal studies tracking the early pathophysiological development of hypertension in black populations, the African-PREDICT study was initiated. The purpose of this paper is to describe the detailed methodology and baseline cohort profile of the study. Methods and results From 2013 to 2017, the study included 1202 black ( N = 606) and white ( N = 596) men and women (aged 20–30 years) from South Africa – screened to be healthy and clinic normotensive. At baseline, and each 5-year follow-up examination, detailed measures of health behaviours, cardiovascular profile and organ damage are taken. Also, comprehensive biological sampling for the ‘omics’ and biomarkers is performed. Overall, the baseline black and white cohort presented with similar ages, clinic and 24-hour blood pressures, but black adults had lower socioeconomic status and higher central systolic blood pressure than white individuals. Conclusions The prospective African-PREDICT study in young black and white adults will contribute to a clear understanding of early cardiovascular disease development.
Published: 2019

47. MAP17 Expression in Colorectal Cancer Is a Prognostic Factor for Disease Recurrence and Dismal Prognosis Already in Early Stage Disease

Author: Nikolaos Nikiteas, Martin Bolli, Athanasios Tampakis, Gerasimos Tsourouflis, Alberto Posabella, Ekaterini Christina Tampaki, Markus von Flüe, Evangelos Felekouras, Gregory Kouraklis, Afroditi Nonni, Lana Fourie, and Michael Kontos
Subjects: Oncology, Adult, Male, Cancer Research, medicine.medical_specialty, Colorectal cancer, Perineural invasion, Cancer stem cell, Risk Factors, Internal medicine, medicine, Biomarkers, Tumor, Humans, Clinical significance, Progression-free survival, Aged, Neoplasm Staging, Aged, 80 and over, Proportional hazards model, business.industry, Endothelial Cells, Membrane Proteins, General Medicine, Middle Aged, medicine.disease, Prognosis, Immunohistochemistry, Progression-Free Survival, Lymphatic Metastasis, Cancer cell, Population study, Female, Morbidity, Neoplasm Recurrence, Local, business, Colorectal Neoplasms
Abstract: Background: Disease recurrence in colorectal cancer constitutes a major cause of significant cancer-associated morbidity and mortality. MAP17 is a small protein, and its overexpression in malignant tumors has been correlated with aggressive tumor phenotypes. The aim of the present study was to investigate the expression patterns of MAP17 in colorectal cancer specimens and to assess its clinical significance. Patients and Methods: Surgical specimens of 111 patients with primary resectable colorectal cancer constituted the study population. Expression of MAP17 was assessed by immunohistochemistry, and the results were correlated with clinical and survival data. Results: MAP17 was expressed in cancer cells and endothelial cells of tumor blood vessels. Expression of MAP17 more than 10% was correlated with advanced disease stage (p < 0.001), higher T classification (p = 0.007), the presence of lymph node metastasis (p < 0.001), vascular (p = 0.013) and perineural invasion (p = 0.012). Patients exhibiting MAP17 expression of more than 30% in cancer cells compared to those expressing MAP17 less than 10% demonstrated a significantly worse 3-year progression-free survival (35.2 vs. 91%, p < 0.001) and 5-year overall survival (40.8 vs. 91%, p < 0.001). Cox regression analysis confirmed MAP17 expression of more than 30% as a prognostic marker of progression free survival (HR 0.136, 95% CI = 0.056–0.329, p < 0.001) and overall survival (HR 0.144 [95% CI) = 0.049–0.419, p < 0.001) independent of other clinicopathological characteristics. Statistically significantly worse 3-year progression-free survival and 5-year overall survival was demonstrated in the subgroup analysis of patients with early stage cancer only and high expression of MAP17. Conclusions: High MAP17 expression in patients with colorectal cancer is a significant risk factor for cancer-associated morbidity and mortality already in early stage disease.
Published: 2020

48. Testosterone and Dihydrotestosterone Changes in Male and Female Athletes Relative to Training Status

Author: Benjamin G. Serpell, Liam P. Kilduff, Christian J. Cook, Blair T. Crewther, Phillip Fourie, and Linda L. Agnew
Subjects: 0301 basic medicine, Male, medicine.medical_specialty, Saliva, medicine.drug_class, Physical Therapy, Sports Therapy and Rehabilitation, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, medicine, Humans, Orthopedics and Sports Medicine, Testosterone, Exercise, Free testosterone, biology, Athletes, business.industry, Large effect size, Dihydrotestosterone, 030229 sport sciences, Androgen, biology.organism_classification, Oxygen uptake, 030104 developmental biology, Endocrinology, Female, business, medicine.drug
Abstract: Purpose: To establish if training volume was associated with androgen baselines and androgen responsiveness to acute exercise. Methods: During a “high-volume” training phase, 28 cyclists (14 men and 14 women) undertook oxygen-uptake and maximal-work-capacity testing. Two days later, they completed a repeat-sprint protocol, which was repeated 3 weeks later during a “low-volume” phase. Blood and saliva samples were collected before and after (+5 and +60 min) the repeat-sprint protocol. Blood was assayed for total testosterone (TT), free testosterone (FT), and dihydrotestosterone (DHT) and saliva, for testosterone and DHT. Results: Pretrial TT, FT, and DHT concentration was greater for males (P P Conclusion: DHT showed no acute performance correlation but was responsive to volume of training, particularly in females. This work informs on timelines and relationships of androgenic biomarkers in males and females across different training loads, adding to the complexity that should be considered in interpretation thereof. The authors speculate that testosterone may impact acute performance via behavioral mechanisms of motivation and attention; DHT, via training volume-induced androgenic promotion, may facilitate long-term adaptive changes, especially for females.
Published: 2020

49. Satisfaction and quality of life in patients with symptomatic gastroenteropancreatic neuroendocrine tumours treated with lanreotide Autogel in South Africa

Author: Alicia McMaster, Natalie Jonas, Bernardo Leon Rapoport, Anca I. Pirjol, Celia Bouharati, Jill Harris, Waldemar M. Szpak, Samuel Fourie, Daleen Geldenhuys, Michiel Botha, Monique Nel, and Sylvia Rodrigues
Subjects: 0301 basic medicine, medicine.medical_specialty, somatostatin analogues, business.industry, Lanreotide Autogel, lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, lcsh:RC254-282, 03 medical and health sciences, 030104 developmental biology, 0302 clinical medicine, lanreotide autogel, Quality of life, 030220 oncology & carcinogenesis, Internal medicine, oncology, gastroenteropancreatic neuroendocrine tumours, Medicine, Observational study, In patient, neuroendocrine tumours, business, Adverse effect
Abstract: Background: Neuroendocrine tumours are known to impact patients’ quality of life because of the symptoms caused by hypersecretion of serotonin and other peptides, in particular diarrhoea and flushing. Aim: The Q-SYMTU study was a prospective, observational registry that included 24 symptomatic patients with gastroenteropancreatic neuroendocrine tumours. Setting: Multiple oncology practices in South Africa. Method: Patients’ level of satisfaction was evaluated for a 6-month period from initiation of treatment with lanreotide Autogel. Results: The number of patients who had greater than 50% self-reported reduction in daily episodes of diarrhoea and flushing were 67% and 80%, respectively, over a 6-month period. Conclusion: Treatment with lanreotide Autogel was generally well tolerated, as demonstrated by low occurrence of Grade 3 and Grade 4 adverse events (AEs). None of the Grade 4 AEs were related to the study treatment. No Grade 5 AEs were reported.
Published: 2020

50. Clinical Experience With Severe Acute Respiratory Syndrome Coronavirus 2-Related Illness in Children: Hospital Experience in Cape Town, South Africa

Author: A'ishah da Costa, Marieke M. van der Zalm, Andrew Redfern, Neshaad Schrueder, Mikhail Barday, Justina Itana, Helena Rabie, Noor Parker, Lilly M. Verhagen, Liezl Smit, Mathilda Claassen, Gert U. van Zyl, Pierre Goussard, Sandra van Jaarsveld, Ilse Appel, Jessica J Workman, Dries Ruttens, Marije Van Schalkwyk, Juanita Lishman, and Barend Fourie
Subjects: Microbiology (medical), Pediatrics, medicine.medical_specialty, Tuberculosis, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), MIS-C, HIV Infections, Disease, medicine.disease_cause, Hospital experience, 03 medical and health sciences, South Africa, 0302 clinical medicine, Interquartile range, 030225 pediatrics, Cape, Lower respiratory tract infection, medicine, Major Article, Humans, 030212 general & internal medicine, Child, Children, Coronavirus, Sub-Saharan Africa, business.industry, SARS-CoV-2, COVID-19, Infant, medicine.disease, Hospitals, respiratory virus infections, Infectious Diseases, AcademicSubjects/MED00290, Child, Preschool, business
Abstract: Background Children seem relatively protected from serious severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)–related disease, but little is known about children living in settings with high tuberculosis and human immunodeficiency virus (HIV) burden. This study reflects clinical data on South African children with SARS-CoV-2. Methods We collected clinical data of children aged Results One hundred fifty-nine children (median age, 48.0 months [interquartile range {IQR}, 12.0–106.0 months]) were included. Hospitalized children (n = 62), with a median age of 13.5 months (IQR, 1.8–43.5 months) were younger than children not admitted (n = 97; median age, 81.0 months [IQR, 34.5–120.5 months]; P Conclusions Children
Published: 2020

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