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9,135 results on '"St. Paul's Hospital"'

1. Trial Evaluating 3-year Disease Free Survival in Patients With Locally Advanced Rectal Cancer Treated With Chemoradiation Plus Induction or Consolidation Chemotherapy and Total Mesorectal Excision or Non-operative Management

Author

Colon and Rectal Surgery Inc., The Cleveland Clinic, John Muir Health, Oregon Health and Science University, St. Joseph Hospital of Orange, University of California, Irvine, University of California, San Francisco, University of Chicago, University of South Florida, University of Vermont, University of Washington, Medstar Health Research Institute, Washington University School of Medicine, Creighton University Medical Center, The Methodist Hospital Research Institute, University of Rochester, University of Virginia, St. Paul's Hospital, St. Joseph, Florida, Cleveland Clinic Florida, University of Colorado, Denver, and University of Michigan

Published
2025

4. Birth Companion Intervention in Ethiopia, Kenya and Nigeria

Author

Addis Continental Institute of Public Health, St Paul's Hospital Millennium Medical College, International Center for Reproductive Health Kenya, Bill and Melinda Gates Foundation, Maternal and Reproductive Health Research Collective, and Della Berhanu, Research lead

Published
2024

12. Quinolone Prophylaxis for the Prevention of BK Virus Infection in Kidney Transplantation: A Pilot Study

Author

Canadian Institutes of Health Research (CIHR), St. Paul's Hospital, Canada, Vancouver General Hospital, University of Alberta, University of Manitoba, University Health Network, Toronto, Unity Health Toronto, St. Joseph's Healthcare Hamilton, London Health Sciences Centre, McGill University Health Centre/Research Institute of the McGill University Health Centre, and Dalhousie University

Published
2023

14. The Norwegian Nucleoside Analogue Stop Study (Nuc-Stop)

Author

University Hospital, Akershus, Addis Ababa University, St. Paul's Hospital Millennium Medical College, Ethiopia, South-Eastern Norway Regional Health Authority, Norway, Bærum Hospital, Norway, Drammen Hospital, Norway, Tønsberg Hospital, Norway, Stavanger University Hospital, Norway, Ålesund Hospital, Norway, Bodø Hospital, Norway, Hvidovre University Hospital, Karolinska University Hospital, and Asgeir Johannessen, Consultant/ researcher

Published
2023

17. Chronic Obstructive Pulmonary Disease Biomarker Study

Author

Genome British Columbia, Centres of Excellence for Commercialization and Research, Canadian Institutes of Health Research (CIHR), Genome Quebec, Providence Health & Services, St. Paul's Hospital, Canada, and Don Sin, Dr. Don Sin

Published
2021

19. A Study to Evaluate the Lipid Regulating Effects of 1-Methylnicotinamide (1-MNA)

Author

Commonwealth Medical Clinic, Institut de Recherches Cliniques de Montreal, Clinique des maladies lipidiques de Québec, Centre de médecine genique communautaire, Omnispec clinical research Inc, Manna Research, St. Jerome Medical Research Inc., Royal Victoria Hospital, Canada, Hotel Dieu Hospital, St Michael's Hospital Health Center, Cambridge Cardiac Care Centre, Maritime Research Center, Rhodin Recherche Clinique, Queen Elizabeth II Health Sciences Centre, First Line Medical Ltd, Diabetes Research, Vancouver General Hosp, The Allin Clinic, St Paul's Hospital Healthy Heart Clinical Trial, The Clinical Trials Centre, Recherche Invascor Inc, MSHJ Research Associates, Dr.Kim W Tan, and Jean-Claude Tardif/Researcher

Published
2020

20. Kidney Transplant Failure

Author

Canadian Institutes of Health Research (CIHR), St. Paul's Hospital, Canada, Vancouver General Hospital, Queen's University, University of Saskatchewan, University of Calgary, University of Manitoba, University Health Network, Toronto, Unity Health Toronto, St. Joseph's Healthcare Hamilton, London Health Sciences Centre, McGill University Health Centre/Research Institute of the McGill University Health Centre, Maisonneuve-Rosemont Hospital, Centre hospitalier de l'Université de Montréal (CHUM), CHU de Quebec-Universite Laval, and University of Alberta

Published
2019

21. Gerontology Research Programme: The Singapore Longitudinal Ageing Studies (SLAS I & II) (SLAS)

Author

Karolinska Institutet, Tan Tock Seng Hospital, Ng Teng Fong General Hospital, St Luke's Hospital, Singapore, St. Paul's Hospital, Canada, Singapore Institute of Technology, Duke-NUS Graduate Medical School, Melbourne Health, University of California, University Hospital, Basel, Switzerland, Université de Sherbrooke, University Hospital Tuebingen, National University Hospital, Singapore, Khoo Teck Puat Hospital, Shanghai Jiao Tong University School of Medicine, University of British Columbia, and A/Prof Ng Tze Pin, Associate Professorial Fellow and Research Director

Published
2019

22. Building Research Initiative Group: Chronic Illness Management and Adherence in Transplantation (BRIGHT)

Author

KU Leuven, University of Missouri, Kansas City, Universitaire Ziekenhuizen KU Leuven, Hospital Universitario À Coruña, Spain, Azienda Ospedaliero, Universitaria Pisana, Hannover Medical School, Johns Hopkins University, US Department of Veterans Affairs, George Washington University, Cliniques universitaires Saint-Luc- Université Catholique de Louvain, Hopital Louis Pradel, Hôpital Nord Laennec, France, Groupe Hospitalier Pitie-Salpetriere, University Hospital Heidelberg, University Hospital, Udine, Italy, University of Bologna, Hospital de Sant Pau, Puerta de Hierro University Hospital, Hospital Universitario La Fe, Hospital Universitario Reina Sofia de Cordoba, Insel Gruppe AG, University Hospital Bern, University Hospital, Zürich, Papworth Hospital NHS Foundation Trust, Freeman Hospital, UK, Royal Brompton & Harefield NHS Foundation Trust, Toronto General Hospital, University of Ottawa Heart Institute, Canada, St. Paul's Hospital, Canada, London Health Sciences Centre, Duke University Hospital, USA, Virginia Commonwealth University, The Cleveland Clinic, Cedars-Sinai Medical Center, Kaiser Permanente, St Luke's Hospital, USA, Hospital of the University of Pennsylvania, USA, Ochsner Health System, Hospital Israelita Albert Einstein, Instituto Dante Pazzanese de Cardiologia, Instituto do Coração da Universidade de São Paulo, Brazil, St Vincent's Hospital, Sydney, The Prince Charles Hospital, Astellas Pharma Europe Ltd., UK, and Sabina De Geest, PhD, RN, FAAN, FRCN

Published
2019

23. Frailty Assessment Before Cardiac Surgery & Transcatheter Interventions

Author

Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Duke University, Hopital du Sacre-Coeur de Montreal, Massachusetts General Hospital, McGill University Health Centre/Research Institute of the McGill University Health Centre, McMaster University, Montreal Heart Institute, Royal Victoria Hospital, Canada, St. Boniface Hospital, Unity Health Toronto, St. Paul's Hospital, Canada, Ottawa Heart Institute Research Corporation, and Jonathan Afilalo, MD MSc FACC FRCPC

Published
2016

24. Fish Oil for Patients With Liver Disease Due to Parenteral Nutrition

Author

ASPEN Rhoads Research Foundation, Fresenius Kabi, University of Alberta, Foothills Medical Centre, St. Boniface Hospital, Hamilton Health Sciences Corporation, St. Paul's Hospital, Canada, and Johane Allard, Professor of Medicine, Gastroenterologist

Published
2016

25. Virtual Ward for Home Dialysis (Virtual Ward)

Author

Baxter Healthcare Corporation, Vancouver General Hospital, Sunnybrook Health Sciences Centre, St. Paul's Hospital, Canada, University of Alberta, Unity Health Toronto, The Ottawa Hospital, Capital Health Nova Scotia, and Christopher Chan, Deputy Director-Nephrology/UHN

Published
2016

28. Health Facility Networking for Maternal Health

Author

Bill and Melinda Gates Foundation, Maternal Health Task Force, St. Paul's Hospital Millennium Medical College, Ethiopia, Addis Continental Institute of Public Health, Institute for Clinical Effectiveness and Health Policy, and Ana Langer, Professor of the Practice of Public Health Coordinator of the Dean's Special Initiative in Women and Health

Published
2015

31. The Canadian Lung Outcomes in Users of Vaping Devices Study (CLOUD)

Author

BC Children's Hospital Research Institute, Providence Healthcare, British Columbia Cancer Agency, University of Alberta, McMaster University, University of Ottawa, Université de Sherbrooke, University of Toronto, and Janice Leung, Assistant Professor, Department of Medicine, University of British Columbia, Principal Investigator, Centre for Heart Lung Innovation, St. Paul's Hospital, Respirologist, St. Paul's Hospital

Published
2025

33. Machine Learning-Based Single Cell and Integrative Analysis Reveals That Baseline mDC Predisposition Correlates With Hepatitis B Vaccine Antibody Response

Author

Brian D. Aevermann, Casey P. Shannon, Mark Novotny, Rym Ben-Othman, Bing Cai, Yun Zhang, Jamie C. Ye, Michael S. Kobor, Nicole Gladish, Amy Huei-Yi Lee, Travis M. Blimkie, Robert E. Hancock, Alba Llibre, Darragh Duffy, Wayne C. Koff, Manish Sadarangani, Scott J. Tebbutt, Tobias R. Kollmann, Richard H. Scheuermann, J. Craig Venter Institute [La Jolla, USA] (JCVI), St. Paul’s Hospital - University of British Columbia [Vancouver, BC, Canada], University of British Columbia (UBC), The University of Western Australia (UWA), Simon Fraser University (SFU.ca), Immunologie Translationnelle - Translational Immunology lab, Institut Pasteur [Paris], Human Vaccines Project [New York], BC Children's Hospital Research Institute [Vancouver, BC, Canada] (BCCHR), University of California [San Diego] (UC San Diego), University of California, La Jolla Institute for Immunology [La Jolla, CA, États-Unis], This work was supported by the Human Vaccines Project. Additional funding from the Canadian Institutes for Health Research FDN-154287 to RH is gratefully acknowledged. RH holds a Canada Research Chair and a UBC Killam Professorship. DD acknowledges support from the Milieu Interieur Consortium., St. Paul’s Hospital - University of British Columbia [Vancouver, BC, Canada] (SPH-UBC), Institut Pasteur [Paris] (IP)-Université Paris Cité (UPCité), and University of California (UC)

Subjects
Male, Endotype, medicine.disease_cause, computer.software_genre, 0302 clinical medicine, baseline correlates, Immunology and Allergy, Medicine, MESH: High-Throughput Nucleotide Sequencing, MESH: Hepatitis B Antibodies, Original Research, canonical correlation analysis, MESH: Aged, 0303 health sciences, MESH: Middle Aged, MESH: Machine Learning, MESH: Dendritic Cells, Vaccination, High-Throughput Nucleotide Sequencing, Middle Aged, vaccines, Hepatitis B, 3. Good health, MESH: Canonical Correlation Analysis, machine learning, endotypes, 030220 oncology & carcinogenesis, Host-Pathogen Interactions, [SDV.IMM]Life Sciences [q-bio]/Immunology, Female, Single-Cell Analysis, MESH: Vaccine Efficacy, Adult, Hepatitis B vaccine, Immunology, Vaccine Efficacy, Machine learning, 03 medical and health sciences, MESH: Gene Expression Profiling, Immune system, single cell RNA sequencing, Humans, Hepatitis B Vaccines, dendritic cells, Hepatitis B Antibodies, 030304 developmental biology, Aged, Hepatitis B virus, MESH: Hepatitis B Vaccines, Innate immune system, MESH: Humans, MESH: Hepatitis B, business.industry, Gene Expression Profiling, MESH: Host-Pathogen Interactions, MESH: Adult, Dendritic cell, MESH: Vaccination, RC581-607, MESH: Male, Immunization, Artificial intelligence, Immunologic diseases. Allergy, business, computer, MESH: Female, MESH: Single-Cell Analysis
Abstract

International audience; Vaccination to prevent infectious disease is one of the most successful public health interventions ever developed. And yet, variability in individual vaccine effectiveness suggests that a better mechanistic understanding of vaccine-induced immune responses could improve vaccine design and efficacy. We have previously shown that protective antibody levels could be elicited in a subset of recipients with only a single dose of the hepatitis B virus (HBV) vaccine and that a wide range of antibody levels were elicited after three doses. The immune mechanisms responsible for this vaccine response variability is unclear. Using single cell RNA sequencing of sorted innate immune cell subsets, we identified two distinct myeloid dendritic cell subsets (NDRG1-expressing mDC2 and CDKN1C-expressing mDC4), the ratio of which at baseline (pre-vaccination) correlated with the immune response to a single dose of HBV vaccine. Our results suggest that the participants in our vaccine study were in one of two different dendritic cell dispositional states at baseline – an NDRG2-mDC2 state in which the vaccine elicited an antibody response after a single immunization or a CDKN1C-mDC4 state in which the vaccine required two or three doses for induction of antibody responses. To explore this correlation further, genes expressed in these mDC subsets were used for feature selection prior to the construction of predictive models using supervised canonical correlation machine learning. The resulting models showed an improved correlation with serum antibody titers in response to full vaccination. Taken together, these results suggest that the propensity of circulating dendritic cells toward either activation or suppression, their “dispositional endotype” at pre-vaccination baseline, could dictate response to vaccination.

Published
2021
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35. Systems Biology Methods Applied to Blood and Tissue for a Comprehensive Analysis of Immune Response to Hepatitis B Vaccine in Adults

Author

Rym Ben-Othman, Bing Cai, Aaron C. Liu, Natallia Varankovich, Daniel He, Travis M. Blimkie, Amy H. Lee, Erin E. Gill, Mark Novotny, Brian Aevermann, Sibyl Drissler, Casey P. Shannon, Sarah McCann, Kim Marty, Gordean Bjornson, Rachel D. Edgar, David Tse Shen Lin, Nicole Gladish, Julia Maclsaac, Nelly Amenyogbe, Queenie Chan, Alba Llibre, Joyce Collin, Elise Landais, Khoa Le, Samantha M. Reiss, Wayne C. Koff, Colin Havenar-Daughton, Manraj Heran, Bippan Sangha, David Walt, Mel Krajden, Shane Crotty, Devin Sok, Bryan Briney, Dennis R. Burton, Darragh Duffy, Leonard J. Foster, William W. Mohn, Michael S. Kobor, Scott J. Tebbutt, Ryan R. Brinkman, Richard H. Scheuermann, Robert E. W. Hancock, Tobias R. Kollmann, Manish Sadarangani, BC Children's Hospital Research Institute [Vancouver, BC, Canada] (BCCHR), University of British Columbia (UBC), The University of Western Australia (UWA), Simon Fraser University (SFU.ca), J. Craig Venter Institute [La Jolla, USA] (JCVI), St. Paul’s Hospital - University of British Columbia [Vancouver, BC, Canada] (SPH-UBC), Immunologie Translationnelle - Translational Immunology lab, Institut Pasteur [Paris] (IP), The Scripps Research Institute [La Jolla, San Diego], La Jolla Institute for Immunology [La Jolla, CA, États-Unis], Human Vaccines Project [New York], Harvard Medical School [Boston] (HMS), St. Paul’s Hospital - University of British Columbia [Vancouver, BC, Canada], Institut Pasteur [Paris], The Scripps Research Institute [La Jolla], University of California [San Diego] (UC San Diego), and University of California-University of California

Subjects
lcsh:Immunologic diseases. Allergy, Adult, Male, 0301 basic medicine, Hepatitis B virus, Hepatitis B vaccine, Systems biology, Immunology, Computational biology, 03 medical and health sciences, 0302 clinical medicine, Immune system, Antibody Repertoire, Monitoring, Immunologic, Immunity, vaccine, Methods, Humans, Immunology and Allergy, Medicine, Hepatitis B Vaccines, Prospective Studies, Microbiome, bio-informatic, Aged, Whole blood, Aged, 80 and over, multi-omic, business.industry, Systems Biology, Vaccination, Middle Aged, lymph node, Hepatitis B, 3. Good health, single cell, Treatment Outcome, 030104 developmental biology, immunimonitoring, gene expression, [SDV.IMM]Life Sciences [q-bio]/Immunology, Female, lcsh:RC581-607, business, 030215 immunology
Abstract

International audience; Conventional vaccine design has been based on trial-and-error approaches, which have been generally successful. However, there have been some major failures in vaccine development and we still do not have highly effective licensed vaccines for tuberculosis, HIV, respiratory syncytial virus, and other major infections of global significance. Approaches at rational vaccine design have been limited by our understanding of the immune response to vaccination at the molecular level. Tools now exist to undertake in-depth analysis using systems biology approaches, but to be fully realized, studies are required in humans with intensive blood and tissue sampling. Methods that support this intensive sampling need to be developed and validated as feasible. To this end, we describe here a detailed approach that was applied in a study of 15 healthy adults, who were immunized with hepatitis B vaccine. Sampling included ~350 mL of blood, 12 microbiome samples, and lymph node fine needle aspirates obtained over a ~7-month period, enabling comprehensive analysis of the immune response at the molecular level, including single cell and tissue sample analysis. Samples were collected for analysis of immune phenotyping, whole blood and single cell gene expression, proteomics, lipidomics, epigenetics, whole blood response to key immune stimuli, cytokine responses, in vitro T cell responses, antibody repertoire analysis and the microbiome. Data integration was undertaken using different approaches-NetworkAnalyst and DIABLO. Our results demonstrate that such intensive sampling studies are feasible in healthy adults, and data integration tools exist to analyze the vast amount of data generated from a multi-omics systems biology approach. This will provide the basis for a better understanding of vaccine-induced immunity and accelerate future rational vaccine design.

Published
2020
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36. Mortality and acute exacerbation of COPD: a pilot study on the influence of myocardial injury

Author

Richard W. Troughton, Said Laribi, Erwin Hansconrad, Justina Motiejunaite, Mehmet Yilmaz, Christian Mueller, Semir Nouira, Kenan Ahmet Turkdogan, Agim Beshiri, Wenjia Chen, Zaid Sabti, Chris J. Pemberton, Alexandre Mebazaa, J. Mark FitzGerald, Jean-Marie Launay, Malha Sadoune, Lyndsey Kirwan, Mercedes Rivas-Lasarte, Corinne Collet, Patrick Plaisance, Mark Richards, Etienne Gayat, Biomarqueurs CArdioNeuroVASCulaires (BioCANVAS), Université Paris 13 (UP13)-Université Paris Diderot - Paris 7 (UPD7)-Institut National de la Santé et de la Recherche Médicale (INSERM), Département de Médecine d'Urgence [CHU Tours], Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Ecole de Médecine [Tours], Université de Tours (UT), Department of Medicine [Christchurch, New Zealand], University of Otago [Dunedin, Nouvelle-Zélande], Emergency Dept and Research Unit UR06SP21 [Monastir, Tunisia], CHU Fattouma Bourguiba [Monastir] (HFB), Department of Emergeny Medicine [Aydin, Turkey], Adnan Menderes Üniversitesi, Department of Cardiology [Sivas, Turkey], Cumhuriyet University [Sivas, Turkey], Université Sorbonne Paris Cité (USPC), Service d'Anesthésie-Réanimation [AP-HP Hôpitaux Saint-Louis Lariboisière], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Lariboisière-Fernand-Widal [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Cardiology Department [Barcelona, Spain], Hospital de la Santa Creu i Sant Pau, Department of Internal Medicine [Basel, Switzerland], University Hospital Basel [Basel], Département de Médecine d'Urgence [AP-HP Hôpitaux universitaires Saint-Louis, Lariboisière, Fernand-Widal], AP-HP Hôpitaux universitaires Saint-Louis, Lariboisière, Fernand-Widal, Department of Cardiology [Kaunas, Lithuania], Hospital of Lithuanian University of Health Sciences Kauno Klinikos [Kaunas, Lithuania], Medical and Scientific Affairs [Abbott Park, IL, USA], Abbott Laboratories, Respiratory Division [Vancouver, BC, Canada], University of British Columbia - UBC [Vancouver, BC, Canada], Service de Biochimie [AP-HP Hôpitaux Saint-Louis Lariboisière], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7)-Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [Paris], UBC and VGH Divisions of Respiratory Medicine [Vancouver, BC, Canada], St. Paul’s Hospital - University of British Columbia [Vancouver, BC, Canada]-Institute for Heart and Lung Health [Vancouver, BC, Canada], Cardiovascular Research Institute [Singapour], National University of Singapore (NUS), Vilnius University [Lithuania], This study was funded by ThermoFisher. A. Mebazaa and J. Motiejunaite would like to acknowledgethe support of the Research Council of Lithuania, grant number MIP-049/2015., Université Paris Diderot - Paris 7 (UPD7), Service de biochimie INSERM UMR-S942, Hôpital Lariboisière-APHP, Service des Urgences, Hôpital Lariboisière, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7), Institut fuer Theoretische Physik (Institut fuer Theoretische Physik), Universität Heidelberg [Heidelberg], U942, Hop Lariboisiere, AP HP,Dept Biochem, Institut National de la Santé et de la Recherche Médicale (INSERM), Département d'Anesthésie Réanimation SMUR [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [Paris], St. Paul’s Hospital - University of British Columbia [Vancouver, BC, Canada] (SPH-UBC)-Institute for Heart and Lung Health [Vancouver, BC, Canada], Mebazaa, Alexandre, Centre Hospitalier Régional Universitaire de Tours (CHRU TOURS), Université de Tours, Université Paris Diderot - Paris 7 (UPD7)-Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), [Laribi, Said] Francois Rabelais Univ, Sch Med, Tours, France -- [Laribi, Said] Tours Univ Hosp, Emergency Med Dept, Tours, France -- [Laribi, Said -- Kirwan, Lyndsey -- Gayat, Etienne -- Rivas-Lasarte, Mercedes -- Sadoune, Malha -- Motiejunaite, Justina -- Plaisance, Patrick -- Launay, Jean-Marie -- Mebazaa, Alexandre] INSERM, U942, BIOmarkers CArdioNeuroVASc Dis, Paris, France -- [Pemberton, Chris J. -- Troughton, Richard W. -- Richards, Mark] Univ Otago, Dept Med, Christchurch Heart Inst, Christchurch, New Zealand -- [Nouira, Semir] Fattouma Bourguiba Univ Hosp, Emergency Dept, Monastir, Tunisia -- [Nouira, Semir] Fattouma Bourguiba Univ Hosp, Res Unit UR06SP21, Monastir, Tunisia -- [Turkdogan, Kenan] Adnan Menderes Univ, Fac Med, Dept Emergeny Med, Aydin, Turkey -- [Yilmaz, Mehmet Birhan] Cumhuriyet Univ, Fac Med, Dept Cardiol, Sivas, Turkey -- [Gayat, Etienne -- Plaisance, Patrick -- Mebazaa, Alexandre] Univ Paris Diderot, Sorbonne Paris Cite, Paris, France -- [Gayat, Etienne -- Motiejunaite, Justina -- Mebazaa, Alexandre] St Louis Lariboisiere Hosp, AP HP, Dept Anesthesiol & Crit Care, Paris, France -- [Rivas-Lasarte, Mercedes] Univ Autonoma Barcelona, Biomed Res Inst IIB St Pau, Hosp Santa CreuiSt Pau, Cardiol Dept, Barcelona, Spain -- [Sabti, Zaid -- Mueller, Christian] Univ Hosp, Dept Internal Med, Basel, Switzerland -- [Hansconrad, Erwin -- Plaisance, Patrick] St Louis Lariboisiere Hosp, AP HP, Emergency Med Dept, Paris, France -- [Motiejunaite, Justina] Lithuanian Univ Hlth Sci Kauno Klinikos, Dept Cardiol, Kaunas, Lithuania -- [Beshiri, Agim] Abbott Labs, Abbott Pk, IL 60064 USA -- [Chen, Wenjia] Univ British Columbia, Resp Div, Inst Heart & Lung Hlth, Vancouver, BC, Canada -- [Collet, Corinne] St Louis Lariboisiere Hosp, AP HP, Dept Biochem, Paris, France -- [FitzGerald, J. Mark] Inst Heart & Lung Hlth, UBC Div Resp Med, Vancouver, BC, Canada -- [FitzGerald, J. Mark] Inst Heart & Lung Hlth, VGH Div Resp Med, Vancouver, BC, Canada -- [Richards, Mark] Natl Univ Singapore, Cardiovasc Res Inst, Singapore, Singapore -- [Mebazaa, Alexandre] Vilnius Univ, Vilnius, Lithuania, YILMAZ, Mehmet Birhan -- 0000-0002-8169-8628, YILMAZ, MEHMET BIRHAN -- 0000-0002-8169-8628, Chen, Wenjia -- 0000-0001-8201-7145, GAYAT, Etienne -- 0000-0002-3334-3849, Mebazaa, Alexandre -- 0000-0001-8715-7753, and collet, corinne -- 0000-0001-6990-863X

Subjects
Male, Pulmonary and Respiratory Medicine, medicine.medical_specialty, Exacerbation, [SDV]Life Sciences [q-bio], Pilot Projects, 030204 cardiovascular system & hematology, Severity of Illness Index, [SDV.MHEP.PSR]Life Sciences [q-bio]/Human health and pathology/Pulmonology and respiratory tract, law.invention, Cohort Studies, Pulmonary Disease, Chronic Obstructive, 03 medical and health sciences, 0302 clinical medicine, Copeptin, [SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system, Interquartile range, law, Internal medicine, Natriuretic Peptide, Brain, medicine, Humans, Myocardial infarction, Intensive care medicine, ComputingMilieux_MISCELLANEOUS, Aged, COPD, business.industry, Myocardium, Mortality rate, Glycopeptides, Middle Aged, Prognosis, medicine.disease, Intensive care unit, Troponin, [SDV.MHEP.CSC] Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system, 3. Good health, 030228 respiratory system, Cohort, Regression Analysis, [SDV.MHEP.PSR] Life Sciences [q-bio]/Human health and pathology/Pulmonology and respiratory tract, Female, Cardiomyopathies, business, Biomarkers
Abstract

WOS: 000404447400031, PubMed ID: 28663316, …, ThermoFisher; Research Council of Lithuania [MIP-049/2015]; Crossref Funder Registry, This study was funded by ThermoFisher. A. Mebazaa and J. Motiejunaite would like to acknowledge the support of the Research Council of Lithuania, grant number MIP-049/2015. Funding information for this article has been deposited with the Crossref Funder Registry.

Published
2017
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37. Characteristics and outcomes of patients screened for transcatheter mitral valve implantation: 1-year results from the CHOICE-MI registry

Author

Ben Ali, Walid, Ludwig, Sebastian, Duncan, Alison, Weimann, Jessica, Nickenig, Georg, Tanaka, Tetsu, Coisne, Augustin, Vincentelli, Andre, Makkar, Raj, Webb, John G., Akodad, Mariama, Muller, David W.M., Praz, Fabien, Wild, Mirjam G., Hausleiter, Jörg, Goel, Sachin S., von Ballmoos, Moritz Wyler, Denti, Paolo, Chehab, Omar, Redwood, Simon, Dahle, Gry, Baldus, Stephan, Adam, Matti, Ruge, Hendrik, Lange, Rüdiger, Kaneko, Tsuyoshi, Leroux, Lionel, Dumonteil, Nicolas, Tchetche, Didier, Treede, Hendrik, Flagiello, Michele, Obadia, Jean Francois, Walther, Thomas, Taramasso, Maurizio, Søndergaard, Lars, Bleiziffer, Sabine, Rudolph, Tanja K., Fam, Neil, Kempfert, Joerg, Granada, Juan F., Tang, Gilbert H.L., von Bardeleben, Ralph Stephan, Conradi, Lenard, Modine, Thomas, Kalbacher, Daniel, Blankenberg, Stefan, Koell, Benedikt, Schofer, Niklas, Westermann, Dirk, Weber, Marcel, CarMeN, laboratoire, Montreal Heart Institute - Institut de Cardiologie de Montréal, Universitaetsklinikum Hamburg-Eppendorf = University Medical Center Hamburg-Eppendorf [Hamburg] (UKE), German Center for Cardiovascular Research (DZHK), Berlin Institute of Health (BIH), Cardiovascular Research Foundation [New York, NY, USA] (CRF), Royal Brompton Hospital, Heart Center Bonn [Bonn, Germany] (HCB), University Hospital Bonn, CHU Lille, Cedars-Sinai Medical Center, St. Paul’s Hospital - University of British Columbia [Vancouver, BC, Canada] (SPH-UBC), St. Vincent's Hospital, Sydney, Bern University Hospital [Berne] (Inselspital), Ludwig Maximilian University [Munich] (LMU), Houston Methodist Hospital [Houston, TX, USA], IRCCS Ospedale San Raffaele [Milan, Italy], Guy's and St Thomas' Hospital [London], Oslo University Hospital [Oslo], University Hospital of Cologne [Cologne], German Heart Center = Deutsches Herzzentrum München [Munich, Germany] (GHC), Brigham and Women’s Hospital [Boston, MA], Harvard Medical School [Boston] (HMS), CHU Bordeaux [Bordeaux], Clinique Pasteur [Toulouse], University Medical Center [Mainz], Hôpital Louis Pradel [CHU - HCL], Hospices Civils de Lyon (HCL), Frankfurt University Hospital, Heart Center Hirslanden = HerzZentrum Hirslanden [Zürich, Switzerland] (HCL), Hôpital national = Rigshospitalet [Copenhagen, Denmark] (HNC), Heart and Diabetes Center NRW [Bad Oeynhausen, Germany] (HDC), St. Michael's Hospital, Mount Sinai Hospital [New York City, NY, USA] (MSH), University Heart Center [Hamburg], CHOICE-MI Investigators: Daniel Kalbacher, Stefan Blankenberg, Benedikt Koell, Niklas Schofer, Dirk Westermann, Marcel Weber, Johanna Vogelhuber, François Pontana, Eric Van Belle, Sung-Han Yoon, Anthony Chuang, Robert H Boone, Paul Jansz, Ning Song, Sara Hungerford, Stephan Windecker, David Reineke, Michael Reardon, Neal S Kleiman, Alessandra Sala, Eustachio Agricola, Francesco Maisano, Ronak Rajani, Bernard Prendergast, Kjell A Rein, Maria I Koerber, Laurin Ochs, Keti Vitanova, Magdalena Erlebach, Pinak Shah, Morgan Harloff, Guillaume Bonnet, Mathieu Pernot, Melchior Jonveaux, Felix Kreidel, Tobias Ruf, Matteo Pozzi, Razvan Dragulescu, Tomas Holubec, Heike Strohschnitter, Claudia Walther, Alberto Pozzoli, Ivan Wong, Kai Friedrichs, Mark Peterson, Axel Unbehaun, Markus Kofler., Ben Ali, Walid, Ludwig, Sebastian, Duncan, Alison, Weimann, Jessica, Nickenig, Georg, Tanaka, Tetsu, Coisne, Augustin, Vincentelli, Andre, Makkar, Raj, Webb, John G, Akodad, Mariama, Muller, David W M, Praz, Fabien, Wild, Mirjam G, Hausleiter, Jörg, Goel, Sachin S, von Ballmoos, Moritz Wyler, Denti, Paolo, Chehab, Omar, Redwood, Simon, Dahle, Gry, Baldus, Stephan, Adam, Matti, Ruge, Hendrik, Lange, Rüdiger, Kaneko, Tsuyoshi, Leroux, Lionel, Dumonteil, Nicola, Tchetche, Didier, Treede, Hendrik, Flagiello, Michele, Obadia, Jean-Francoi, Walther, Thoma, Taramasso, Maurizio, Søndergaard, Lar, Bleiziffer, Sabine, Rudolph, Tanja K, Fam, Neil, Kempfert, Joerg, Granada, Juan F, Tang, Gilbert H L, von Bardeleben, Ralph Stephan, Conradi, Lenard, Modine, Thoma, and Agricola, Eustachio

Subjects
Heart Failure, Heart Valve Prosthesis Implantation, Cardiac Catheterization, Medical therapy, [SDV]Life Sciences [q-bio], 610 Medizin, Mitral valve surgery, Mitral Valve Insufficiency, 610 Medicine & health, [SDV] Life Sciences [q-bio], Treatment Outcome, 610 Medical sciences, Humans, Mitral Valve, Registries, Cardiology and Cardiovascular Medicine, Transcatheter mitral valve implantation, Transcatheter edge-to-edge repair, Mitral regurgitation
Abstract

AIMS Transcatheter mitral valve implantation (TMVI) represents a novel treatment option for patients with mitral regurgitation (MR) unsuitable for established therapies. The CHOICE-MI registry aimed to investigate outcomes of patients undergoing screening for TMVI. METHODS AND RESULTS From 05/2014 to 03/2021, patients with MR considered suboptimal candidates for transcatheter edge-to-edge repair (TEER) and at high risk for mitral valve surgery underwent TMVI screening at 26 centres. Characteristics and outcomes were investigated for patients undergoing TMVI and for TMVI-ineligible patients referred to bailout-TEER, high-risk surgery or medical therapy (MT). The primary composite endpoint was all-cause mortality or heart failure hospitalisation after 1 year. Among 746 patients included (78.5 years [IQR 72.0-83.0], EuroSCORE II 4.7% [IQR 2.7-9.7]), 229 patients (30.7%) underwent TMVI with ten different dedicated devices. At 1 year, residual MR ≤1+ was present in 95.2% and the primary endpoint occurred in 39.2% of patients treated with TMVI. In TMVI-ineligible patients (N = 517, 69.3%), rates of residual MR ≤1+ were 37.2%, 100.0% and 2.4% after bailout-TEER, high-risk surgery and MT, respectively. The primary endpoint at 1 year occurred in 28.8% of patients referred to bailout-TEER, in 42.9% of patients undergoing high-risk surgery and in 47.9% of patients remaining on MT. CONCLUSION This registry included the largest number of patients treated with TMVI to date. TMVI with ten dedicated devices resulted in predictable MR elimination and sustained functional improvement at 1 year. In TMVI-ineligible patients, bailout-TEER and high-risk surgery represented reasonable alternatives, while MT was associated with poor clinical and functional outcomes. This article is protected by copyright. All rights reserved.

Published
2022
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38. Design, conduct, and analysis of a multicenter, pharmacogenomic, biomarker study in matched patients with severe sepsis treated with or without drotrecogin Alfa (activated)

Author

Anthony C. Gordon, Jonathan E. Sevransky, Frank Stüber, James A. Russell, Patrick J. Heagerty, Mauricio Neira, Alexandra D. J. Mancini, Djillali Annane, Hugh Wellman, Lorraine B. Ware, Jean Paul Mira, CIT-IT Garches, Assistance publique - Hôpitaux de Paris (AP-HP)-AP-HP Hôpital Raymond Poincaré [Garches]-Institut National de la Santé et de la Recherche Médicale ( INSERM ), Médecine Générale et Soins Intensifs, Université de Versailles Saint-Quentin-en-Yvelines ( UVSQ ) -Assistance publique - Hôpitaux de Paris (AP-HP)-AP-HP Hôpital Raymond Poincaré [Garches], Université Paris Descartes - Paris 5 ( UPD5 ), Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University School of Medicine, Section of Anaesthetics, Pain Medicine, and Intensive Care, Imperial College London-Charing Cross Hospital, MICU, John Hopkins BMC, Inselspital Bern, Biostatistics, University of Washington [Seattle], Sirius Genomics, Sirius Genomics Inc, Critical Care Research Laboratories, St. Paul's Hospital-The James Hogg iCAPTURE Centre for Cardiovascular and Pulmonary Research-University of British Columbia ( UBC ), BMC, Ed., Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Raymond Poincaré [AP-HP]-Institut National de la Santé et de la Recherche Médicale (INSERM), Hôpital Raymond Poincaré [AP-HP], Université Paris Descartes - Paris 5 (UPD5), Vanderbilt University School of Medicine [Nashville], and St. Paul's Hospital-The James Hogg iCAPTURE Centre for Cardiovascular and Pulmonary Research-University of British Columbia (UBC)

Subjects
medicine.medical_specialty, Propensity score, Survival, [SDV.MHEP.PHY] Life Sciences [q-bio]/Human health and pathology/Tissues and Organs [q-bio.TO], Predictive marker, 030204 cardiovascular system & hematology, Pharmacogenomics biomarker, Critical Care and Intensive Care Medicine, Sepsis, 03 medical and health sciences, 0302 clinical medicine, Drotrecogin alfa activated (DAA), Anesthesiology, Internal medicine, [SDV.MHEP.PHY]Life Sciences [q-bio]/Human health and pathology/Tissues and Organs [q-bio.TO], Medicine, 030212 general & internal medicine, Intensive care medicine, Drotrecogin alfa (activated), APACHE II, [ SDV.MHEP.PHY ] Life Sciences [q-bio]/Human health and pathology/Tissues and Organs [q-bio.TO], business.industry, Drotrecogin alfa, Research, Treatment selection, medicine.disease, Severe sepsis, 3. Good health, Activated protein C, Propensity score matching, Biomarker (medicine), Genome wide association study, business, medicine.drug, Companion diagnostic
Abstract

Background A genomic biomarker identifying patients likely to benefit from drotrecogin alfa (activated) (DAA) may be clinically useful as a companion diagnostic. This trial was designed to validate biomarkers (improved response polymorphisms (IRPs)). Each IRP (A and B) contains two single nucleotide polymorphisms that were associated with a differential DAA treatment effect. Methods DAA is typically given to younger patients with greater disease severity; therefore, a well-matched control group is critical to this multicenter, retrospective, controlled, outcome-blinded, genotype-blinded trial. Within each center, DAA-treated patients will be matched to controls treated within 24 months of each other taking into account age, APACHE II, cardiovascular, respiratory, renal, and hematologic dysfunction, mechanical ventilation status, medical/surgical status, and infection site. A propensity score will estimate the probability that a patient would have received DAA given their baseline characteristics. Two-phase data transfer will ensure unbiased selection of matched controls. The first transfer will be for eligibility and matching data and the second transfer for outcomes and genotypic data. The primary analysis will compare the effect of DAA in IRP + and IRP − groups on in-hospital mortality through day 28. Discussion A design-based approach matching DAA-free to DAA-treated patients in a multicenter study of patients who have severe sepsis and high risk of death will directly compare control to DAA-treated groups for mortality by genotype. Results, which should be available in 2012, may help to identify the group of patients who would benefit from DAA and may provide a model for future investigation of sepsis therapies.

Published
2012
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39. International recommendations for a vascular access minimum dataset: a Delphi consensus-building study

Author

Fredrik Hammarskjold, Gail Egan, Amanda J. Ullman, Nicole Marsh, Jocelyn Hill, Jessica A Schults, İlker Devrim, M Pedreira, Carole Hallam, Olivier Mimoz, Michelle DeVries, Claire M. Rickard, Vineet Chopra, Rebecca Paterson, Suzanne Oakley, Tricia Kleidon, Sergio Bertoglio, Ton van Boxtel, Marie Cooke, Gillian Ray-Barruel, Maria Magalhaes, Griffith University [Brisbane], Queensland Children's Hospital, Partenaires INRAE, Menzies Health Institute Queensland, Griffith University Brisbane, University of Michigan [Ann Arbor], University of Michigan System, Royal Brisbane & Women's Hospital, St. Paul’s Hospital - University of British Columbia [Vancouver, BC, Canada], Dr Behcet Uz Children Res & Training Hosp, Ryhov Hospital, Federal University of Sao Paulo (Unifesp), University of Genoa (UNIGE), Centre hospitalier universitaire de Poitiers (CHU Poitiers), University Medical Center [Utrecht], and Cleveland Clinic Abu Dhabi [Abou Dabi, Émirats arabes unis]

Subjects
Consensus, Delphi Technique, [SDV]Life Sciences [q-bio], Vascular access, quality measurement, 030204 cardiovascular system & hematology, 03 medical and health sciences, Patient safety, 0302 clinical medicine, information technology, Surveys and Questionnaires, patient safety, Humans, Medicine, 030212 general & internal medicine, Original Research, computer.programming_language, Response rate (survey), Data collection, business.industry, Health Policy, Information technology, Device type, performance measures, [SDV.SP]Life Sciences [q-bio]/Pharmaceutical sciences, medicine.disease, 3. Good health, Medical emergency, business, healthcare quality improvement, Vascular Access Devices, computer, Delphi
Abstract

BackgroundData regarding vascular access device use and outcomes are limited. In part, this gap reflects the absence of guidance on what variables should be collected to assess patient outcomes. We sought to derive international consensus on a vascular access minimum dataset.MethodsA modified Delphi study with three rounds (two electronic surveys and a face-to-face consensus panel) was conducted involving international vascular access specialists. In Rounds 1 and 2, electronic surveys were distributed to healthcare professionals specialising in vascular access. Survey respondents were asked to rate the importance of variables, feasibility of data collection and acceptability of items, definitions and response options. In Round 3, a purposive expert panel met to review Round 1 and 2 ratings and reach consensus (defined as ≥70% agreement) on the final items to be included in a minimum dataset for vascular access devices.ResultsA total of 64 of 225 interdisciplinary healthcare professionals from 11 countries responded to Round 1 and 2 surveys (response rate of 34% and 29%, respectively). From the original 52 items, 50 items across five domains emerged from the Delphi procedure.Items related to demographic and clinical characteristics (n=5; eg, age), device characteristics (n=5; eg, device type), insertion (n=16; eg, indication), management (n=9; eg, dressing and securement), and complication and removal (n=15, eg, occlusion) were identified as requirements for a minimum dataset to track and evaluate vascular access device use and outcomes.ConclusionWe developed and internally validated a minimum dataset for vascular access device research. This study generated new knowledge to enable healthcare systems to collect relevant, useful and meaningful vascular access data. Use of this standardised approach can help benchmark clinical practice and target improvements worldwide.

Published
2021
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41. Update on asthma–copd overlap (Aco):A narrative review

Author

Antonio Anzueto, Andréanne Côté, Diego J. Maselli, Don D. Sin, Charlotte Suppli Ulrik, Marc Miravitlles, François Maltais, Chin Kook Rhee, Alexa Nuñez, Evgeni Mekov, Masakazu Ichinose, Institut Català de la Salut, [Mekov E] Department of Occupational Diseases, Medical Faculty, Medical University of Sofia, Sofia, Bulgaria. [Nuñez A, Miravitlles M] Servei de Pneumologia, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institut de Recerca (VHIR), Barcelona, Spain. CIBER de Enfermedades Respiratorias (CIBERES), Barcelona, Spain. [Sin DD] Centre for Heart Lung Innovation, St. Paul’s Hospital, Department of Medicine (Respiratory Division), University of British Columbia, Vancouver, BC, Canada. [Ichinose M] Academic Center of Osaki Citizen Hospital, Miyagi, Japan. [Rhee CK] Division of Pulmonary, Allergy and Critical Care Medicine, Department of Internal Medicine, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea. [Maselli DJ] Division of Pulmonary Diseases & Critical Care, University of Texas Health, South Texas Veterans Health Care System, San Antonio, TX, USA, and Vall d'Hebron Barcelona Hospital Campus

Subjects
Epidemiology, Review, Pulmonary Disease, Chronic Obstructive, 0302 clinical medicine, Adrenal Cortex Hormones, Medicine, genetics, Other subheadings::/therapeutic use [Other subheadings], 030212 general & internal medicine, Lung, COPD, Hormones, Hormone Substitutes, and Hormone Antagonists::Hormones::Adrenal Cortex Hormones [CHEMICALS AND DRUGS], treatment, Smoking, General Medicine, Prognosis, Asma - Prognosi, Obstructive lung disease, enfermedades respiratorias::enfermedades pulmonares::enfermedades pulmonares obstructivas::enfermedad pulmonar obstructiva crónica [ENFERMEDADES], Narrative review, epidemiology, medicine.medical_specialty, Corticosteroides - Ús terapèutic, Inhaled corticosteroids, Pulmons - Malalties obstructives - Prognosi, 03 medical and health sciences, Genetics, hormonas, sustitutos de hormonas y antagonistas de hormonas::hormonas::hormonas de la corteza suprarrenal [COMPUESTOS QUÍMICOS Y DROGAS], Humans, In patient, Asthma copd overlap, Intensive care medicine, Asthma, ACO, Respiratory Tract Diseases::Lung Diseases::Lung Diseases, Obstructive::Pulmonary Disease, Chronic Obstructive [DISEASES], Otros calificadores::/uso terapéutico [Otros calificadores], business.industry, biomarkers, Respiratory Tract Diseases::Bronchial Diseases::Asthma [DISEASES], asthma, medicine.disease, respiratory tract diseases, Treatment, 030228 respiratory system, enfermedades respiratorias::enfermedades bronquiales::asma [ENFERMEDADES], prognosis, business, Biomarkers
Abstract

MPOC; Asma; Pronòstic EPOC; Asma; Pronóstico COPD; Asthma; Prognosis Although chronic obstructive pulmonary disease (COPD) and asthma are well-characterized diseases, they can coexist in a given patient. The term asthma–COPD overlap (ACO) was introduced to describe patients that have clinical features of both diseases and may represent around 25% of COPD patients and around 20% of asthma patients. Despite the increasing interest in ACO, there are still substantial controversies regarding its definition and its position within clinical guidelines for patients with obstructive lung disease. In general, most definitions indicate that ACO patients must present with non-reversible airflow limitation, significant exposure to smoking or other noxious particles or gases, together with features of asthma. In patients with a primary diagnosis of COPD, the identification of ACO has therapeutic implication because the asthmatic component should be treated with inhaled corticosteroids and some studies suggest that the most severe patients may respond to biological agents indicated for severe asthma. This manuscript aims to summarize the current state-of-the-art of ACO. The definitions, prevalence, and clinical manifestations will be reviewed and some innovative aspects, such as genetics, epigenetics, and biomarkers will be addressed. Lastly, the management and prognosis will be outlined as well as the position of ACO in the COPD and asthma guidelines.

Published
2021
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43. International Severe Asthma Registry: Mission Statement

Author

Canonica, G. Walter, Alacqua, Marianna, Altraja, Alan, Backer, Vibeke, Bel, Elisabeth, Bjermer, Leif, Bjornsdottir, Unnur, Bourdin, Arnaud, Brusselle, Guy G., Christoff, George C., Cosio, Borja G., Costello, Richard W., FitzGerald, J. Mark, Gibson, Peter G., Heaney, Liam G., Heffler, Enrico, Hew, Mark, Iwanaga, Takashi, Jones, Rupert C., Siyue, Mariko Koh, Rhee, Chin Kook, Lehmann, Sverre, Lehtimäki, Lauri A., Ludviksdottir, Dora, Maitland-van der Zee, Anke Hilse, Menzies-Gow, Andrew N., Papadopoulos, Nikolaos G., Plaza, Vicente, Perez de Llano, Luis, Peters, Matthew, Porsbjerg, Celeste M., Sadatsafavi, Mohsen, Cho, You Sook, Tohda, Yuji, Tran, Trung N., Wang, Eileen, Zangrilli, James, Bulathsinhala, Lakmini, Carter, Victoria A., Chaudhry, Isha, Eleangovan, Neva, Hosseini, Naeimeh, Le, Thao L., Murray, Ruth B., Price, Chris A., Price, David B., Allergy & Respiratory Diseases Clinic - DIMI, University of Genoa (UNIGE), AstraZeneca, Luton, United Kingdom of Great Britain and Northern Ireland., Physiologie & médecine expérimentale du Cœur et des Muscles [U 1046] (PhyMedExp), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), UBC and VGH Divisions of Respiratory Medicine [Vancouver, BC, Canada], St. Paul’s Hospital - University of British Columbia [Vancouver, BC, Canada]-Institute for Heart and Lung Health [Vancouver, BC, Canada], Dipartimento di Scienze Mediche, Università degli studi di Torino (UNITO), Royal Brompton Hospital, Lung Division, London, United Kingdom of Great Britain and Northern Ireland., AstraZeneca, Gaithersburg, Maryland, United States., MedScript Ltd, Aberystwyth University, Division of Infection and Immunity [Cardiff, UK] (School of Medicine), and Cardiff University

Subjects
Pulmonary and Respiratory Medicine, ISAR, severe asthma, DEFINITION, OMALIZUMAB, [SDV]Life Sciences [q-bio], Medicine and Health Sciences, PHENOTYPES, ADULTS, Critical Care and Intensive Care Medicine, Cardiology and Cardiovascular Medicine, COSTS, PREVALENCE
Abstract

International audience; Regional and/or national severe asthma registries provide valuable country-specific information. However, they are often limited in scope within the broader definitions of severe asthma, have insufficient statistical power to answer many research questions, lack intra-operability to share lessons learned, and have fundamental differences in data collected, making cross comparisons difficult. What is missing is a worldwide registry which brings all severe asthma data together in a cohesive way, under a single umbrella, based on standardized data collection protocols, permitting data to be shared seamlessly. The International Severe Asthma Registry (ISAR; http://isaregistries.org/) is the first global adult severe asthma registry. It is a joint initiative where national registries (both newly created and pre-existing) retain ownership of their own data but open their borders and share data with ISAR for ethically approved research purposes. Its strength comes from collection of patient level, anonymous, longitudinal, real-life, standardized, high-quality data (using a core set of variables) from countries across the world, combined with organizational structure, database experience, inclusivity/openness, and clinical, academic, and database expertise. This gives ISAR sufficient statistical power to answer important research questions, sufficient data standardization to compare across countries and regions, and the structure and expertise necessary to ensure its continuance as well as the scientific integrity and clinical applicability of its research. ISAR offers a unique opportunity to implement existing knowledge, generate new knowledge, and identify the unknown, therefore promoting new research. The aim of this commentary is to fully describe how ISAR may improve our understanding of severe asthma.

Published
2019
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44. ERS statement on respiratory muscle testing at rest and during exercise

Author

Denis E. O'Donnell, Pierantonio Laveneziana, Frédéric Sériès, Brigitte Fauroux, Joaquim Gea, J. Alberto Neder, André Luis Pereira de Albuquerque, Ioannis Vogiatzis, Esther Barreiro, Bruno-Pierre Dubé, Samuel Verges, Christina M. Spengler, Martin Dres, Yuan Ming Luo, Daniel Langer, Andrea Rossi, Franco Laghi, Thomas Similowski, Jordan A. Guenette, Tony G. Babb, Hans-Joachim Kabitz, Roberto A Rabinovich, Michael I. Polkey, Anna L. Hudson, Andrea Aliverti, Neurophysiologie Respiratoire Expérimentale et Clinique (UMRS 1158), Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Universidade de São Paulo = University of São Paulo (USP), Hospital Sírio-Libanês [São Paulo, Brazil], Politecnico di Milano [Milan] (POLIMI), Texas Health Presbyterian Hospital [Dallas, TX, USA], IMIM-Hospital del Mar, Generalitat de Catalunya, Centre Hospitalier de l'Université de Montréal (CHUM), Université de Montréal (UdeM), Centre de Recherche du Centre Hospitalier de l’Université de Montréal (CR CHUM), Université de Montréal (UdeM)-Université de Montréal (UdeM), CHU Necker - Enfants Malades [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Université Paris Descartes - Paris 5 (UPD5), Universitat Pompeu Fabra [Barcelona] (UPF), University of British Columbia (UBC), University of New South Wales [Sydney] (UNSW), Hochschule Konstanz (HTWG Konstanz), Loyola University [Chicago], Edward Hines, Jr. VA Hospital, Catholic University of Leuven - Katholieke Universiteit Leuven (KU Leuven), University Hospitals Leuven [Leuven], The First Affiliated Hospital of Guangzhou Medical University (GMU), Queen's University [Kingston, Canada], Royal Brompton Hospital, University of Edinburgh, Royal Infirmary of Edinburgh, Università degli studi di Verona = University of Verona (UNIVR), Université Laval [Québec] (ULaval), Universität Zürich [Zürich] = University of Zurich (UZH), St. Paul’s Hospital - University of British Columbia [Vancouver, BC, Canada] (SPH-UBC), National and Kapodistrian University of Athens (NKUA), University of Northumbria at Newcastle [United Kingdom], Hypoxie et PhysioPathologie (HP2), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Grenoble Alpes (UGA), and SALAS, Danielle

Subjects
Pulmonary and Respiratory Medicine, medicine.medical_specialty, [SDV]Life Sciences [q-bio], Rest, Psychological intervention, Respiratory physiology, Electromyography, Disease, 030204 cardiovascular system & hematology, Structured light plethysmography, 03 medical and health sciences, 0302 clinical medicine, Physical medicine and rehabilitation, medicine, Respiratory muscle, Humans, Muscle Strength, Respiratory system, Exercise, Societies, Medical, medicine.diagnostic_test, Pulmons -- Músculs, business.industry, Transcranial Magnetic Stimulation, C600, Aparell respiratori -- Fisiologia, Respiratory Muscles, Respiratory Function Tests, [SDV] Life Sciences [q-bio], Europe, B900, 030228 respiratory system, Respiratory Mechanics, Breathing, business
Abstract

Assessing respiratory mechanics and muscle function is critical for both clinical practice and research purposes. Several methodological developments over the past two decades have enhanced our understanding of respiratory muscle function and responses to interventions across the spectrum of health and disease. They are especially useful in diagnosing, phenotyping and assessing treatment efficacy in patients with respiratory symptoms and neuromuscular diseases. Considerable research has been undertaken over the past 17 years, since the publication of the previous American Thoracic Society (ATS)/European Respiratory Society (ERS) statement on respiratory muscle testing in 2002. Key advances have been made in the field of mechanics of breathing, respiratory muscle neurophysiology (electromyography, electroencephalography and transcranial magnetic stimulation) and on respiratory muscle imaging (ultrasound, optoelectronic plethysmography and structured light plethysmography). Accordingly, this ERS task force reviewed the field of respiratory muscle testing in health and disease, with particular reference to data obtained since the previous ATS/ERS statement. It summarises the most recent scientific and methodological developments regarding respiratory mechanics and respiratory muscle assessment by addressing the validity, precision, reproducibility, prognostic value and responsiveness to interventions of various methods. A particular emphasis is placed on assessment during exercise, which is a useful condition to stress the respiratory system. ispartof: EUROPEAN RESPIRATORY JOURNAL vol:53 issue:6 ispartof: location:England status: published

Published
2019
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45. Benralizumab for the Prevention of COPD Exacerbations

Author

Criner, G. J., Celli, B. R., Brightling, C. E., Agusti, A., Papi, A., Singh, D., Sin, D. D., Vogelmeier, C. F., Sciurba, F. C., Bafadhel, M., Backer, V., Kato, M., Ramirez-Venegas, A., Wei, Y. -F., Bjermer, L., Shih, V. H., Jison, M., O'Quinn, S., Makulova, N., Newbold, P., Goldman, M., Martin, U. J., GALATHEA Study Investigators, TERRANOVA Study Investigators, Otto, Burghuber, Bernhard, Forstner, Gerhard, Köberl, Bernd, Lamprecht, Judith, Löffler-Ragg, Horst, Olschewski, Michael, Studnicka, Francois, Beaucage, Guy, Chouinard, Anthony, Dechant, Anthony, Dowell, Jacques, Hebert, Sohail, Khattak, Kieran, Killian, William, Killorn, Andy, Lam, Francois, Maltais, Darcy, Marciniuk, Lyle, Melenka, Bonavuth, Pek, Jeremy, Road, Donald, Sin, Alain, Vaugeois, Brandie, Walker, Tomas, Dvorak, Stanislav, Holub, Otakar, Hokynar, Vitezslav, Kolek, Daniela, Kopecka, Jan, Krepelka, Jaroslav, Mares, Josef, Veverka, Vladimir, Zindr, Sabine, Ballenberger, Rolf, Dichmann, Christian, Geßner, Margret, Jandl, Claus, Keller, Joachim, Kirschner, Marc, Kornmann, Petra, Mikloweit, Ingomar, Naudts, Axel, Overlack, Isabelle, Schenkenberger, Volker, Schlegel, Lutz Von Versen, Claus Franz Vogelmeier, Stefan, Zielen, István, Albert, Beatrix, Bálint, Mária Csilla Hangonyi, Teréz, Kecskés, Anikó, Kurucz, Balázs, Medgyasszay, Lajos, Molnár, János, Mucsi, Márta, Papp, Magdolna, Póczi, Éva, Radeczky, Zsolt Pápai Székely, Csilla, Szabó, Gyöngyi, Szabó, Melinda, Szabó, Alfredo Antonio Chetta, Giuseppe Di Maria, Giulio, Donazzan, Federica, Meloni, Elisabetta, Pace, Pierluigi, Paggiaro, Alberto, Papi, Ricciardolo, Fabio Luigi Massimo, Antonio, Spanevello, Fumiaki, Aoki, Ryosuke, Eda, Takeo, Endo, Yasushi, Fukushima, Kenichi, Gemba, Naoki, Hagimoto, Hiromasa, Harada, Yasuko, Harada, Norihiko, Hata, Osamu, Hataji, Nobuo, Hatakeyama, Takahiko, Horiguchi, Gen, Ideura, Motoyasu, Iikura, Azusa, Ikegami, Shirou, Imokawa, Yoshikazu, Inoue, Takeshi, Isobe, Ryoji, Ito, Susumu, Iwata, Tadashi, Kamei, Motokazu, Kato, Hideki, Katsura, Yuji, Kawarada, Norio, Kihara, Masaharu, Kinoshita, Takashi, Kinoshita, Tomoo, Kishaba, Hideo, Kita, Arihiro, Kiyosue, Shigeru, Komatsu, Kazuki, Konishi, Sekiya, Koyama, Makoto, Kudo, Kazuhiko, Machida, Hironi, Makita, Hiroto, Matsuse, Naoki, Miyazawa, Hiroyuki, Nakamura, Yuji, Nakatani, Kazuyuki, Nishimura, Takashi, Nishimura, Junichi, Ogawa, Hiroyuki, Ohbayashi, Tetsuro, Ohdaira, Tsukasa, Ohnishi, Kazuhiko, Oki, Masahiko, Saito, Kenji, Sakamoto, Osamu, Sakamoto, Hisakuni, Sekino, Noriharu, Shijubo, Masaharu, Shinkai, Hideo, Soto, Yoshitaka, Sugawara, Noriaki, Suko, Hisaho, Takahashi, Masamitsu, Takahashi, Tsuneyuki, Takahashi, Hiroshi, Tanaka, Hiroyuki, Taniguchi, Tadayuki, Terada, Takao, Tochigi, Kazuyo, Tohyama, Hirokazu, Tokuyasu, Keisuke, Tomii, Tomomasa, Tsuboi, Mitsuyoshi, Utsugi, Katsumaru, Yamamoto, Michiko, Yamamoto, Shuichi, Yano, Makoto, Yoshida, Frank, Custers, Richard, Dekhuijzen, Remco, Djamin, Jan Willem Van Dan Berg, Lowie, Vanfleteren, Pascal, Wielders, Bogusława, Cimoszko, Anna, Doboszyńska, Andrzej, Dyczek, Andrzej, Fal, Krystyna, Folcik, Łukasz, Goliński, Marek, Jutel, Andrzej, Kolczyński, Piotr, Kuna, Ewa, Łączyńska, Wojciech, Machowiak, Maciej, Marczak, Joanna, Markiewicz, Janusz, Milanowski, Grzegorz, Mincewicz, Maria, Nittner-Marszalska, Wojciech, Papiewski, Małgorzata, Pawlukiewicz, Witold, Pomiećko, Barbara, Rewerska, Cezary, Rybacki, Wojciech, Skucha, Ewa, Trębas-Pietraś, Ewa, Uhryn, Małgorzata, Żurowska-Gębala, Laurentia, Andrei, Traian, Mihaescu, Stefan, Mihaicuta, Eniko Vera Pall, Ioan, Petrui, Angelica, Savu, Claudia, Toma, Ana, Trailescu, Vladimir, Abrosimov, Nataliya, Astafyeva, Evgenyi, Bazdyrev, Nadezhda, Berdnikova, Laura, Bolieva, Ekaterina, Bukreeva, Valery, Chistyakov, Anna, Galustyan, Halida, Gantseva, Svetlana, Goncharova, Sergey, Grigoriev, Galina, Ignatova, Inna, Ilyashevich, Nadezhda, Izmozherova, Magomed, Kamalov, Yaroslava, Khovaeva, Natalia, Kuzubova, Lyudmila, Kvitkova, Liudmila, Lenskaya, Igor, Leshchenko, Olga, Magnitskaya, Boris, Molotilov, Artem, Molotkov, Svetlana, Myasoedova, Sergey, Nedogoda, Vladimir, Nosov, Marina, Osipenko, Andrey, Peskov, Veronika, Popova, Oksana, Ratushnay, Irina, Ryzhova, Olga, Shangina, Natalia, Shaporova, Evgeny, Shmelev, Lybov, Shpagina, Alexander, Shutkin, Yuri, Shvarts, Mikhail, Smirnov, Irina, Stitsenko, Maksim, Vasilev, Arkadiy, Vertkin, Elena, Vishneva, Alexander, Vizel, Anna, Zateyschikova, Mohamed, Abdool-Gaffar, Ismail, Abdullah, Axel, Bruning, Nyda, Fourie, Michael, Greenblatt, Mohammed, Tayob, Venter, K, An Soo Jang, Kwan Ho Lee, Sang Haak Lee, Sook Young Lee, Suk Joong Yong, Kwang Ha Yoo, Soo Taek Uh, Ramón Agüero Balbín, David Ramos Barbón, Álvar Agustí García-Navarro, José Luis Velasco Garrido, Sergi Pascual Guardia, Eduard Monso Molas, Luis De Teresa Parreño, Borja García-Cosio Piqueras, German Peces-Barba Romero, Myriam Calle Rubio, Fernando Sánchez-Toril López, Alicia Marín Tapia, Heidi Martin Braschler, Martin, Brutsche, Michael, Grob, Jörg, Leuppi, Daiana, Stolz, Alexander, Turk, Nawar, Bakerley, Mona, Bafadhel, Christopher, Brightling, Rekha, Chaudhuri, Gourab, Choudhury, Graham, Devereux, Imran, Hussain, Kai, Lee, William, Macnee, Ravindran, Mahadeva, Matthew, Masoli, Monica, Nordstrom, Manish, Patel, Allan, Reid, Dinesh, Saralaya, Tariq, Sethi, Sukh Dave Singh, Anthony, G de Soyza, Tom, Wilkinson, Alice, Turner, Helen, Ward, Chandar, Abboy, Ivan, Ackerman, Idalia, Acosta, Arun, Adlakha, Bassil, Aish, Mohamed, Ali, Charles, Andrews, Robby, Ayoub, Anil, Badhwar, Dennis, Bassetti, Sherif El Bayadi, Richard, Beasley, Shashi, Bellam, Jonathan, Bernstein, Maria, Blahey, Scott, Bloom, Eugene, Bleecker, Wesley, Bray, Johnathan, Brewer, Robert, Buynak, William, Calhoun, Edward, Campbell, Anthony, Captain, Birjis, Chinoy, Kenneth, Chinsky, Geoffrey, Chupp, Arsenio, Columbie, Clinton, Corder, Gerard, Criner, Humberto, Cruz, Edward, Cullen, Kevin, Deboer, Michael, Denenberg, Mark, Dransfield, Leonard, Dunn, Miles, Elmore, David, Erb, Faisal, Fakih, Gary, Ferguson, Charles, Fogarty, Mark, Freed, Stephen, Fritz, David, Fuentes, Shariar, Cohen-Gadol, Robert, Garver, John, Given, Luis Ramos Gonez, Raul Ebran Gonzalez, Robert, Gordon, Gregory, Gottschlich, Donald, Graham, David, Grant, Gary, Greenwald, James, Greenwald, Kenneth, Haft, Gregory, Hammond, Nadia, Hansel, Jeffrey, Harris, Humberto, Hernandez, Marvin, Heuer, Albrecht, Heyder, David, Hill, Willis, Holloway, Octavian, Ioachimescu, Richard, Jackson, Ajay, Jain, Nan, Jiang, Thomas, Kaelin, Adolfo, Kaplan, Mitchell, Kaye, Akram, Khan, Yekaterina, Khronusova, Ryan, Klein, Joel, Kline, Firas, Koura, Ritsu, Kuno, Ware, Kuschner, Jean Claude Labissiere, David Laman Jr, John, Lee, Mitchell, Lee, Lawrence, Levinson, Njira, Lugogo, Mador, M, Nathaniel, Marchetti, Rafael, Martinez, Richard, Martinez, Peter, Mattar, David, Maybee, Dennis, Mcgraw, Michael, Mcguire, Curtis, Mello, Aaron, Milstone, John, Mitchell, Wendy, Moore, Timothy, Moriarty, Cheta, Nand, Brooke, Nevins, Ikeadi, Ndukwu, Rachel, Nisbet, David, Nyanjom, Maria, Nualart, Thomas, O'Brien, Mikhail, Palatnik, Gnyandev, Patel, Amit, Patel, Guido, Perez, Christopher, Perry, Michael, Pfeffer, Krishna, Pudi, Marina, Raikhel, Murali, Ramaswamy, Joe, Ramsdell, Donato, Ricci, Gary, Richmond, Eugene, Ryan, Fadi, Saba, Boris, Sagalovich, C Andrew Schroeder, Timothy, Scialla, Frank, Sciurba, Amit, Shah, Nirav, Shah, Zeeshan, Shaikh, Akhtar, Siddiqui, Barry, Sigal, Thomas, Siler, Howard, Silverboard, William, Sims, Clyde, Southwell, Selwyn, Spangenthal, Peruvemba, Sriram, James, Stocks, Tony, Su, John, Suen, Robert, Sussman, Horia, Tatu, Antonio, Terrelonge, Alan, Thomas, Mario, Torres, Rodolfo, Trejo, Miguel, Trevino, Banks, Turner, Manuel, Villareal, Janine, Vintch, Neal, Warshoff, Jan, Westerman, Philip, Wexler, Thomas, Yunger, Amir, Zeki, Mariano Fernandez Acquier, Norma, Aramayo, German, Arce, Juan, Belloni, Víctor, Cambursano, Carlos De La Vega, Fernando Rodriguez Chariarse, Pedro, Elias, Marcelo, Fernández, Ana, Lopez, Andrea, Medina, María, Otaola, Maria Salazan Saez, Maria De Salvo, Fernando, Scherbovsky, Ana, Stok, Jorge, Taborda, Alberto, Tolcachier, Fernando, Verra, Carlos, Victorio, Rita Gisela Delgado Vizcarra, Philip, Bardin, Peter, Bremner, Martin, Phillips, John, Upham, Peter, Wark, Antoine, Bolly, Alain, Delobbe, Peter, Driesen, Eduard, Janssens, Wim, Janssens, Olivier, Michel, Bernard, Vandooren, Martti, Antila, Jussara, Fiterman, Carlos, Fritscher, Jorge, Hetzel, Jose, Jardim, Waldo De Mattos, Rafael, Martins, Maria Eunice De Oliveira, Andreia, Pez, Maria, Sales, Rafael, Stelmach, Priscila, Wolff, Svetla, Andreeva, Reneta, Antonova, Ana, Dancheva, Yuliya, Ivanova, Slavcho, Ivanov, Hristo, Metev, Iveta, Naydenova, Tatyana, Petkova, Galina, Petrova, Kostadinka, Sotirova, Mariyana, Stoyanova, Rumen, Tiholov, Iliyana, Valkanova, Oleg, Yakov, Rosa, Feijoo, Juana, Pavie, Patricia, Schönffeldt, Absalon, Silva, Victor, Martinez, David, Espinosa, Alejandro, Londono, Dora, Molina, Gonzalo, Prada, Andrés, Rico, Gregorio Sanchez Vallejo, Alvaro, Urbina, Ana, Vanegas, Maria, Villegas, Josip, Aralica, Gordana, Stjepanovic, Vibeke, Backer, Uffe, Bødtger, Christian, Meyer, Læge Sven Nielsen, Anders Loekke Ottesen, Ingrid, Titlestad, Nathalie, Bautin, Arnaud, Bourdin, Pascal, Chanez, Francis, Couturaud, Antoine, Cuvelier, Gilles, Devouassoux, Pierre-Olivier, Girodet, Jean-François, Muir, Jean-Louis, Pépin, Alain, Proust, Azzedine, Yaici, Yochai, Adir, Gershon, Fink, Zvi, Fridlender, Gabriel, Izbicki, Mordechai, Kramer, Yehuda, Schwartz, Juan Moreno Hoyos Abril, Ricardo Campos Cerda, Efraín Montaño Gonzalez, Ricardo Ramirez Terrones, Rodolfo Posadas Valay, Alejandra, Ramirez-Venegas, Paul, Dawkins, Syed, Hussain, Benedict, Brockway, John, Richmond, Colin, Helm, Catherina, Chang, Jørn, Ahlqvist, Terje, Tollåli, Tadeusz, Tomala, Socorro, Castro, William, Chavez, Octavio, Cubas, Rolando, Estrella, Efrain, Felix, Ronal, Gamarra, Alfredo, Guerreros, Alberto, Matsuno, Danilo, Salazar, Miguel, Tsukayama, Albert Albay Jr, Teresita, Aquino, Tito, Atienza, Joven Roque Gonong, Ronnie, Samoro, Joel, Santiaguel, Beata, Asankowicz-Bargiel, Ewa, Pisarczyk-Bogacka, Renata, Bijata-Bronisz, Marta, Chełmińska, Małgorzata, Dobryniewska, Anna, Olech-Cudzik, Tomasz, Fijołek, Krzysztof, Filipek, Agata, Kot, Bożena, Kucińska, Krzysztof, Lis, Elżbieta, Rybicka-Liszewska, Marzenna, Tarnowska-Matusiak, Robert, Mróz, Piotr, Napora, Wojciech, Naumnik, Artur, Niemiec, Władysław, Pierzchała, Grzegorz, Przybylski, Katarzyna, Styka, Danuta, Wrońska, Branislava, Milenkovic, Dobrivoje, Novkovic, Matijaz, Flezar, Niksa, Segota, Snezana Ulcar Kostic, Albert, Klobucar, Leif, Bjermer, Dan, Curiac, Christer, Janson, Pekka, Koskinen, Lundback, Bo, Åke, Olsson, Shih-Lung, Cheng, Ming-Lin, Ho, Jeng-Yuan, Hsu, Wu-Huei, Hsu, Ping-Hung, Kuo, Chin-Chou, Wang, Yu-Feng, Wei, Kuang-Yao, Yang, Watchara, Boonsawat, Somchai, Chantarothorn, Warangkana, Keeratichananont, Kittipong, Maneechotesuwan, Kanok, Pipatvech, Piamlarp, Sangsayunh, Sibel, Arinc, Sermin, Borekci, Arzu Kaner Erturk, Filiz, Kosar, Hakan, Gunen, Ismail, Hanta, Pinar Akin Kabalak, Tunc Alp Demir, Sibel, Nayci, Serir Aktogu Ozkan, Abdullah, Sayiner, Esra, Uzaslan, Viktor, Blazhko, Volodymyr, Gavrysyuk, Olena, Golub, Liudmyla, Iashyna, Tetiana, Ilashchuk, Volodymyr, Koshlia, Olena, Krakhmalova, Vitali, Kryvenko, Lesia, Kuryk, Olena, Levchenko, Yuriy, Mostovoy, Mykola, Ostrovskyy, Tetyana, Pertseva, Olena, Piura, Nadiya, Rudnytska, Ganna, Stupnytska, Nataliia, Velychko, Oleh, Yakovenko, Lilia Rodriguez Ables, Roger, Abrahams, Jose, Alvarez, Fernando, Arencibia, Chander, Arora, Samir, Arora, Francis, Averill, Kwabena, Ayesu, Stephen, Basheda, Steven, Bauer, Jose, Bautista, Matthew, Beacom, Hernando, Bernal, Subodh, Bhuchar, J'Cinda, Bitters, John, Burk, Elizabeth, Burkett, James, Cain, Robert, Call, Christopher, Chappel, Bartolome, Celli, Tom, Christensen, Jeremy, Cole, Jerome, Daniel, Nguyen, Dang, Enrique, Davis, Samuel, Deleon, Robert, Deluca, Ernesto, Diaz, Anthony, Dimarco, Calvin, Dixon, Ankur, Doshi, Hugh, Durrence, Alain, Eid, John, Elsen, Herbon, Fleming, May, Flores, Scott, Franczek, Gregory, Funk, Stuart, Garay, Bernard, Garcia, Joseph, Graif, 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Leicester, University of Barcelona, Università degli Studi di Ferrara = University of Ferrara (UniFE), University of Manchester [Manchester], St. Paul’s Hospital - University of British Columbia [Vancouver, BC, Canada] (SPH-UBC), Philipps Universität Marburg = Philipps University of Marburg, University of Pittsburgh School of Medicine, University of Oxford, Bispebjerg University Hospital [Copenhagen, Denmark] (BUH), Kishiwada City Hospital [Osaka, Japan] (KCH), Instituto Nacional de Enfermedades Respiratorias [México, Mexico], I-Shou University [Kaohsiung, Taiwan] (ISU), Lund University [Lund], AstraZeneca [Gaithersburg, MD, USA] (AZ), Hypoxie et PhysioPathologie (HP2), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Grenoble Alpes (UGA), and Otto Burghuber, Bernhard Forstner, Gerhard Köberl, Bernd Lamprecht, Judith Löffler-Ragg, Horst Olschewski, Michael Studnicka, Francois Beaucage, Guy Chouinard, Anthony Dechant, Anthony Dowell, Jacques Hebert, Sohail Khattak, Kieran Killian, William Killorn, Andy Lam, Francois Maltais, Darcy Marciniuk, Lyle Melenka, Bonavuth Pek, Jeremy Road, Donald Sin, Alain Vaugeois, Brandie Walker, Tomas Dvorak, Stanislav Holub, Otakar Hokynar, Vitezslav Kolek, Daniela Kopecka, Jan Krepelka, Jaroslav Mares, Josef Veverka, Vladimir Zindr, Sabine Ballenberger, Rolf Dichmann, Christian Geßner, Margret Jandl, Claus Keller, Joachim Kirschner, Marc Kornmann, Petra Mikloweit, Ingomar Naudts, Axel Overlack, Isabelle Schenkenberger, Volker Schlegel, Lutz Von Versen, Claus Franz Vogelmeier, Stefan Zielen, István Albert, Beatrix Bálint, Mária Csilla Hangonyi, Teréz Kecskés, Anikó Kurucz, Balázs Medgyasszay, Lajos Molnár, János Mucsi, Márta Papp, Magdolna Póczi, Éva Radeczky, Zsolt Pápai Székely, Csilla Szabó, Gyöngyi Szabó, Melinda Szabó, Alfredo Antonio Chetta, Giuseppe Di Maria, Giulio Donazzan, Federica Meloni, Elisabetta Pace, Pierluigi Paggiaro, Alberto Papi, Fabio Luigi, Massimo Ricciardolo, Antonio Spanevello, Fumiaki Aoki, Ryosuke Eda, Takeo Endo, Yasushi Fukushima, Kenichi Gemba, Naoki Hagimoto, Hiromasa Harada, Yasuko Harada, Norihiko Hata, Osamu Hataji, Nobuo Hatakeyama, Takahiko Horiguchi, Gen Ideura, Motoyasu Iikura, Azusa Ikegami, Shirou Imokawa, Yoshikazu Inoue, Takeshi Isobe, Ryoji Ito, Susumu Iwata, Tadashi Kamei, Motokazu Kato, Hideki Katsura, Yuji Kawarada, Norio Kihara, Masaharu Kinoshita, Takashi Kinoshita, Tomoo Kishaba, Hideo Kita, Arihiro Kiyosue, Shigeru Komatsu, Kazuki Konishi, Sekiya Koyama, Makoto Kudo, Kazuhiko Machida, Hironi Makita, Hiroto Matsuse, Naoki Miyazawa, Hiroyuki Nakamura, Yuji Nakatani, Kazuyuki Nishimura, Takashi Nishimura, Junichi Ogawa, Hiroyuki Ohbayashi, Tetsuro Ohdaira, Tsukasa Ohnishi, Kazuhiko Oki, Masahiko Saito, Kenji Sakamoto, Osamu Sakamoto, Hisakuni Sekino, Noriharu Shijubo, Masaharu Shinkai, Hideo Soto, Yoshitaka Sugawara, Noriaki Suko, Hisaho Takahashi, Masamitsu Takahashi, Tsuneyuki Takahashi, Hiroshi Tanaka, Hiroyuki Taniguchi, Tadayuki Terada, Takao Tochigi, Kazuyo Tohyama, Hirokazu Tokuyasu, Keisuke Tomii, Tomomasa Tsuboi, Mitsuyoshi Utsugi, Katsumaru Yamamoto, Michiko Yamamoto, Shuichi Yano, Makoto Yoshida, Frank Custers, Richard Dekhuijzen, Remco Djamin, Jan Willem Van Dan Berg, Lowie Vanfleteren, Pascal Wielders, Bogusława Cimoszko, Anna Doboszyńska, Andrzej Dyczek, Andrzej Fal, Krystyna Folcik, Łukasz Goliński, Marek Jutel, Andrzej Kolczyński, Piotr Kuna, Ewa Łączyńska, Wojciech Machowiak, Maciej Marczak, Joanna Markiewicz, Janusz Milanowski, Grzegorz Mincewicz, Maria Nittner-Marszalska, Wojciech Papiewski, Małgorzata Pawlukiewicz, Witold Pomiećko, Barbara Rewerska, Cezary Rybacki, Wojciech Skucha, Ewa Trębas-Pietraś, Ewa Uhryn, Małgorzata Żurowska-Gębala, Laurentia Andrei, Traian Mihaescu, Stefan Mihaicuta, Eniko Vera Pall, Ioan Petrui, Angelica Savu, Claudia Toma, Ana Trailescu, Vladimir Abrosimov, Nataliya Astafyeva, Evgenyi Bazdyrev, Nadezhda Berdnikova, Laura Bolieva, Ekaterina Bukreeva, Valery Chistyakov, Anna Galustyan, Halida Gantseva, Svetlana Goncharova, Sergey Grigoriev, Galina Ignatova, Inna Ilyashevich, Nadezhda Izmozherova, Magomed Kamalov, Yaroslava Khovaeva, Natalia Kuzubova, Lyudmila Kvitkova, Liudmila Lenskaya, Igor Leshchenko, Olga Magnitskaya, Boris Molotilov, Artem Molotkov, Svetlana Myasoedova, Sergey Nedogoda, Vladimir Nosov, Marina Osipenko, Andrey Peskov, Veronika Popova, Oksana Ratushnay, Irina Ryzhova, Olga Shangina, Natalia Shaporova, Evgeny Shmelev, Lybov Shpagina, Alexander Shutkin, Yuri Shvarts, Mikhail Smirnov, Irina Stitsenko, Maksim Vasilev, Arkadiy Vertkin, Elena Vishneva, Alexander Vizel, Anna Zateyschikova, Mohamed Abdool-Gaffar, Ismail Abdullah, Axel Bruning, Nyda Fourie, Michael Greenblatt, Mohammed Tayob, K Venter, An Soo Jang, Kwan Ho Lee, Sang Haak Lee, Sook Young Lee, Suk Joong Yong, Kwang Ha Yoo, Soo Taek Uh, Ramón Agüero Balbín, David Ramos Barbón, Álvar Agustí García-Navarro, José Luis Velasco Garrido, Sergi Pascual Guardia, Eduard Monso Molas, Luis De Teresa Parreño, Borja García-Cosio Piqueras, German Peces-Barba Romero, Myriam Calle Rubio, Fernando Sánchez-Toril López, Alicia Marín Tapia, Heidi Martin Braschler, Martin Brutsche, Michael Grob, Jörg Leuppi, Daiana Stolz, Alexander Turk, Nawar Bakerley, Mona Bafadhel, Christopher Brightling, Rekha Chaudhuri, Gourab Choudhury, Graham Devereux, Imran Hussain, Kai Lee, William MacNee, Ravindran Mahadeva, Matthew Masoli, Monica Nordstrom, Manish Patel, Allan Reid, Dinesh Saralaya, Tariq Sethi, Sukh Dave Singh, Anthony G de Soyza, Tom Wilkinson, Alice Turner, Helen Ward, Chandar Abboy, Ivan Ackerman, Idalia Acosta, Arun Adlakha, Bassil Aish, Mohamed Ali, Charles Andrews, Robby Ayoub, Anil Badhwar, Dennis Bassetti, Sherif El Bayadi, Richard Beasley, Shashi Bellam, Jonathan Bernstein, Maria Blahey, Scott Bloom, Eugene Bleecker, Wesley Bray, Johnathan Brewer, Robert Buynak, William Calhoun, Edward Campbell, Anthony Captain, Birjis Chinoy, Kenneth Chinsky, Geoffrey Chupp, Arsenio Columbie, Clinton Corder, Gerard Criner, Humberto Cruz, Edward Cullen, Kevin Deboer, Michael Denenberg, Mark Dransfield, Leonard Dunn, Miles Elmore, David Erb, Faisal Fakih, Gary Ferguson, Charles Fogarty, Mark Freed, Stephen Fritz, David Fuentes, Shariar Cohen-Gadol, Robert Garver, John Given, Luis Ramos Gonez, Raul Ebran Gonzalez, Robert Gordon, Gregory Gottschlich, Donald Graham, David Grant, Gary Greenwald, James Greenwald, Kenneth Haft, Gregory Hammond, Nadia Hansel, Jeffrey Harris, Humberto Hernandez, Marvin Heuer, Albrecht Heyder, David Hill, Willis Holloway, Octavian Ioachimescu, Richard Jackson, Ajay Jain, Nan Jiang, Thomas Kaelin, Adolfo Kaplan, Mitchell Kaye, Akram Khan, Yekaterina Khronusova, Ryan Klein, Joel Kline, Firas Koura, Ritsu Kuno, Ware Kuschner, Jean Claude Labissiere, David Laman Jr, John Lee, Mitchell Lee, Lawrence Levinson, Njira Lugogo, M Mador, Nathaniel Marchetti, Rafael Martinez, Richard Martinez, Peter Mattar, David Maybee, Dennis McGraw, Michael McGuire, Curtis Mello, Aaron Milstone, John Mitchell, Wendy Moore, Timothy Moriarty, Cheta Nand, Brooke Nevins, Ikeadi Ndukwu, Rachel Nisbet, David Nyanjom, Maria Nualart, Thomas O'Brien, Mikhail Palatnik, Gnyandev Patel, Amit Patel, Guido Perez, Christopher Perry, Michael Pfeffer, Krishna Pudi, Marina Raikhel, Murali Ramaswamy, Joe Ramsdell, Donato Ricci, Gary Richmond, Eugene Ryan, Fadi Saba, Boris Sagalovich, C Andrew Schroeder, Timothy Scialla, Frank Sciurba, Amit Shah, Nirav Shah, Zeeshan Shaikh, Akhtar Siddiqui, Barry Sigal, Thomas Siler, Howard Silverboard, William Sims, Clyde Southwell, Selwyn Spangenthal, Peruvemba Sriram, James Stocks, Tony Su, John Suen, Robert Sussman, Horia Tatu, Antonio Terrelonge, Alan Thomas, Mario Torres, Rodolfo Trejo, Miguel Trevino, Banks Turner, Manuel Villareal, Janine Vintch, Neal Warshoff, Jan Westerman, Philip Wexler, Thomas Yunger, Amir Zeki, Mariano Fernandez Acquier, Norma Aramayo, German Arce, Juan Belloni, Víctor Cambursano, Carlos De La Vega, Fernando Rodriguez Chariarse, Pedro Elias, Marcelo Fernández, Ana Lopez, Andrea Medina, María Otaola, Maria Salazan Saez, Maria De Salvo, Fernando Scherbovsky, Ana Stok, Jorge Taborda, Alberto Tolcachier, Fernando Verra, Carlos Victorio, Rita Gisela Delgado Vizcarra, Philip Bardin, Peter Bremner, Martin Phillips, John Upham, Peter Wark, Antoine Bolly, Alain Delobbe, Peter Driesen, Eduard Janssens, Wim Janssens, Olivier Michel, Bernard Vandooren, Martti Antila, Jussara Fiterman, Carlos Fritscher, Jorge Hetzel, Jose Jardim, Waldo De Mattos, Rafael Martins, Maria Eunice De Oliveira, Andreia Pez, Maria Sales, Rafael Stelmach, Priscila Wolff, Svetla Andreeva, Reneta Antonova, Ana Dancheva, Yuliya Ivanova, Slavcho Ivanov, Hristo Metev, Iveta Naydenova, Tatyana Petkova, Galina Petrova, Kostadinka Sotirova, Mariyana Stoyanova, Rumen Tiholov, Iliyana Valkanova, Oleg Yakov, Rosa Feijoo, Juana Pavie, Patricia Schönffeldt, Absalon Silva, Victor Martinez, David Espinosa, Alejandro Londono, Dora Molina, Gonzalo Prada, Andrés Rico, Gregorio Sanchez Vallejo, Alvaro Urbina, Ana Vanegas, Maria Villegas, Josip Aralica, Gordana Stjepanovic, Vibeke Backer, Uffe Bødtger, Christian Meyer, Læge Sven Nielsen, Anders Loekke Ottesen, Ingrid Titlestad, Nathalie Bautin, Arnaud Bourdin, Pascal Chanez, Francis Couturaud, Antoine Cuvelier, Gilles Devouassoux, Pierre-Olivier Girodet, Jean-François Muir, Jean-Louis Pépin, Alain Proust, Azzedine Yaici, Yochai Adir, Gershon Fink, Zvi Fridlender, Gabriel Izbicki, Mordechai Kramer, Yehuda Schwartz, Juan Moreno Hoyos Abril, Ricardo Campos Cerda, Efraín Montaño Gonzalez, Ricardo Ramirez Terrones, Rodolfo Posadas Valay, Alejandra Ramirez-Venegas, Paul Dawkins, Syed Hussain, Benedict Brockway, John Richmond, Colin Helm, Catherina Chang, Jørn Ahlqvist, Terje Tollåli, Tadeusz Tomala, Socorro Castro, William Chavez, Octavio Cubas, Rolando Estrella, Efrain Felix, Ronal Gamarra, Alfredo Guerreros, Alberto Matsuno, Danilo Salazar, Miguel Tsukayama, Albert Albay Jr, Teresita Aquino, Tito Atienza, Joven Roque Gonong, Ronnie Samoro, Joel Santiaguel, Beata Asankowicz-Bargiel, Ewa Pisarczyk-Bogacka, Renata Bijata-Bronisz, Marta Chełmińska, Małgorzata Dobryniewska, Anna Olech-Cudzik, Tomasz Fijołek, Krzysztof Filipek, Agata Kot, Bożena Kucińska, Krzysztof Lis, Elżbieta Rybicka-Liszewska, Marzenna Tarnowska-Matusiak, Robert Mróz, Piotr Napora, Wojciech Naumnik, Artur Niemiec, Władysław Pierzchała, Grzegorz Przybylski, Katarzyna Styka, Danuta Wrońska, Branislava Milenkovic, Dobrivoje Novkovic, Matijaz Flezar, Niksa Segota, Snezana Ulcar Kostic, Albert Klobucar, Leif Bjermer, Dan Curiac, Christer Janson, Pekka Koskinen, Bo Lundback, Åke Olsson, Shih-Lung Cheng, Ming-Lin Ho, Jeng-Yuan Hsu, Wu-Huei Hsu, Ping-Hung Kuo, Chin-Chou Wang, Yu-Feng Wei, Kuang-Yao Yang, Watchara Boonsawat, Somchai Chantarothorn, Warangkana Keeratichananont, Kittipong Maneechotesuwan, Kanok Pipatvech, Piamlarp Sangsayunh, Sibel Arinc, Sermin Borekci, Arzu Kaner Erturk, Filiz Kosar, Hakan Gunen, Ismail Hanta, Pinar Akin Kabalak, Tunc Alp Demir, Sibel Nayci, Serir Aktogu Ozkan, Abdullah Sayiner, Esra Uzaslan, Viktor Blazhko, Volodymyr Gavrysyuk, Olena Golub, Liudmyla Iashyna, Tetiana Ilashchuk, Volodymyr Koshlia, Olena Krakhmalova, Vitali Kryvenko, Lesia Kuryk, Olena Levchenko, Yuriy Mostovoy, Mykola Ostrovskyy, Tetyana Pertseva, Olena Piura, Nadiya Rudnytska, Ganna Stupnytska, Nataliia Velychko, Oleh Yakovenko, Lilia Rodriguez Ables, Roger Abrahams, Bassil Aish, Jose Alvarez, Fernando Arencibia, Chander Arora, Samir Arora, Francis Averill, Kwabena Ayesu, Stephen Basheda, Steven Bauer, Jose Bautista, Matthew Beacom, Richard Beasley, Hernando Bernal, Subodh Bhuchar, J'Cinda Bitters, John Burk, Elizabeth Burkett, James Cain, Robert Call, Christopher Chappel, Bartolome Celli, Tom Christensen, Jeremy Cole, Jerome Daniel, Nguyen Dang, Enrique Davis, Samuel Deleon, Robert DeLuca, Ernesto Diaz, Anthony DiMarco, Calvin Dixon, Ankur Doshi, Hugh Durrence, Alain Eid, John Elsen, Herbon Fleming, May Flores, Charles Fogarty, Scott Franczek, Stephen Fritz, Gregory Funk, Stuart Garay, Bernard Garcia, Luis Ramos Gonez, Gregory Gottschlich, Joseph Graif, Carl Griffin, Yamirka Duardo Guerra, David Headley, Mitzie Hewitt, Susan Hole, Robert Holladay, Ira Horowitz, Yu-Luen Hsu, Jonathan Ilowite, Stephen Jones, Ravindra Kashyap, Edward Kerwin, Ahtaram Khan, Nicole Kimzey, James Krainson, Flory Kreutter, Kannappan Krishnaswamy, Shahrukh Kureishy, Albert Lai, Alex Lechin, Daria Lee, Marcus Lee, Williams Leeds, Joseph Lillo, Edward Lisberg, Lawrence Madoff, Narendra Maheskwari, Mujibur Majumder, Sashi Makam, Douglas Mapel, Matthew Mardiney, Jennifer Martin, David Maybee, Isaac Melamed, Elvin Mendez, Stuart Millstone, Joseph Montes, Lee Morrow, Frank Murphy, Dany Obeid, France Occy, Godson Oguchi, Juan Ortiz, Francisco Padron, Ward Paine, James Pearle, Enrique Pelayo, Vandely Perez, David Pham, Carlos Piniella, Kevin Pritchett, Padmashri Rastogi, Stephen Ryan, Syed Rehman, Jackson Rhudy, Eustace Riley, James Riser, Clifford Risk, Emory Robinette, Christopher Roney, Gary Ruoff, David Russian, Mercedes Samson, Jay Sandberg, Jose Santiago, William Sargeant, Alan Schecter, Frank Sciurba, Jeffrey Scott, Ilia Segal, Sudhir Sehgal, Frederic Seifer, Sudhir Sekhsaria, Richard Sellman, Paul Shapero, Jeffrey Shea, Lawrence Sher, John Sibille, Jawed Siddiqui, William Sims, Toniya Singh, Deren Sinkowitz, Denise Smyth, Daniel Soteres, Daniel Sousa, Ralph Steele, Thomas Stern, Jose Suarez, Sever Surdulescu, Ricardo Tan, Tonny Tanus, Raymond Tidman, Aurelio Torres-Consuegra, Barry Troyan, John Updegrove, Sanjay Vadgama, Armando Pineda-Velez, Eduardo Viera, Andrew Wachtel, Ralph Wade, Jimin Wang, Dave Webster, Paul Weinberg, Terry Wells, Jeffrey White, Bram Wieskopf, Hugh Windom, Patrick Wright, David Wyatt, Bassam Yousef, Zahid Zafar, Chau Ngo, Huong Le, Lan Nguyen, Thanh Nguyen, Nhung Nguyen

Subjects
Male, [SDV]Life Sciences [q-bio], 030204 cardiovascular system & hematology, Anti-asthmatic Agent, law.invention, Pulmonary Disease, Chronic Obstructive, Leukocyte Count, chemistry.chemical_compound, 0302 clinical medicine, Randomized controlled trial, law, Monoclonal, Receptors, Medicine, Anti-Asthmatic Agents, 030212 general & internal medicine, Humanized, COPD Exacerbations, benralizumab, clinical trials, COPD, Subcutaneous, General Medicine, Middle Aged, anti–IL-5Rα, Benralizumab, Pulmonary Disease, Chronic Obstructive/drug therapy, [SDV] Life Sciences [q-bio], Female, Antibodies, Monoclonal, Humanized/administration & dosage, Chronic Obstructive, Benralizumab COPD exacerbations, Injections, Subcutaneous, Socio-culturale, Aged, Antibodies, Monoclonal, Humanized, Double-Blind Method, Eosinophils, Humans, Patient Acuity, Receptors, Interleukin-5, Antibodies, chronic obstructive pulmonary disease, Injections, Pulmonary Disease, 03 medical and health sciences, Phase III, Anti-Asthmatic Agents/administration & dosage, In patient, business.industry, Eosinophils/metabolism, medicine.disease, Clinical trial, Receptors, Interleukin-5/antagonists & inhibitors, chemistry, Multicenter study, randomized controlled trial, Immunology, Interleukin-5, business
Abstract

BACKGROUND: The efficacy and safety of benralizumab, an interleukin-5 receptor alpha-directed cytolytic monoclonal antibody, for the prevention of exacerbations in patients with moderate to very severe chronic obstructive pulmonary disease (COPD) are not known.METHODS: In the GALATHEA and TERRANOVA trials, we enrolled patients with COPD (at a ratio of approximately 2:1 on the basis of eosinophil count [≥220 per cubic millimeter vs. RESULTS: In GALATHEA, the estimates of the annualized exacerbation rate were 1.19 per year (95% confidence interval [CI], 1.04 to 1.36) in the 30-mg benralizumab group, 1.03 per year (95% CI, 0.90 to 1.19) in the 100-mg benralizumab group, and 1.24 per year (95% CI, 1.08 to 1.42) in the placebo group; the rate ratio as compared with placebo was 0.96 for 30 mg of benralizumab (P = 0.65) and 0.83 for 100 mg of benralizumab (P = 0.05). In TERRANOVA, the estimates of the annualized exacerbation rate for 10 mg, 30 mg, and 100 mg of benralizumab and for placebo were 0.99 per year (95% CI, 0.87 to 1.13), 1.21 per year (95% CI, 1.08 to 1.37), 1.09 per year (95% CI, 0.96 to 1.23), and 1.17 per year (95% CI, 1.04 to 1.32), respectively; the corresponding rate ratios were 0.85 (P = 0.06), 1.04 (P = 0.66), and 0.93 (P = 0.40). At 56 weeks, none of the annualized COPD exacerbation rate ratios for any dose of benralizumab as compared with placebo reached significance in either trial. Types and frequencies of adverse events were similar with benralizumab and placebo.CONCLUSIONS: Add-on benralizumab was not associated with a lower annualized rate of COPD exacerbations than placebo among patients with moderate to very severe COPD, a history of frequent moderate or severe exacerbations, and blood eosinophil counts of 220 per cubic millimeter or greater (Funded by AstraZeneca [GALATHEA and TERRANOVA] and Kyowa Hakko Kirin [GALATHEA]; GALATHEA and TERRANOVA ClinicalTrials.gov numbers, NCT02138916 and NCT02155660.).

Published
2019
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46. Cause-Specific Mortality in HIV-Positive Patients Who Survived Ten Years after Starting Antiretroviral Therapy

Author

Jonathan A C Sterne, Matthias Cavassini, Timothy R. Sterling, Amy C. Justice, Christoph Boesecke, Suzanne M Ingle, Fiona C Lampe, Robert Zangerle, Margaret T May, Victoria Hernando, Heidi M. Crane, Jorg-Janne Vehreschild, Antonella d'Arminio Monforte, Charles Cazanave, Adam Trickey, Colette Smit, José M. Miró, Michael S. Saag, Hasina Samji, Marta Montero, Leah Shepherd, Niels Obel, Sophie Grabar, Michael Gill, Antiretroviral Therapy Cohort Collaboration (ART-CC), University of Bristol [Bristol], Koln University, Köln University, German Centre for Infection Research (DZIF), Partner Site Hamburg, Department of Infectious Diseases [Rigshospitalet], Rigshospitalet [Copenhagen], University of Calgary, University of Washington [Seattle], Rheinische Friedrich-Wilhelms-Universität Bonn, British Columbia Centre for Excellence in HIV/AIDS, St. Paul's Hospital, Institut Pierre Louis d'Epidémiologie et de Santé Publique (iPLESP), Université Pierre et Marie Curie - Paris 6 (UPMC)-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Cochin [AP-HP], Université Paris Descartes - Paris 5 (UPD5), Groupe hospitalier Pellegrin, Université de Lausanne (UNIL), UCL Medical School, Università degli studi di Milano [Milano], Stichting HIV Monitoring [Amsterdam], Universiteit van Amsterdam (UvA), University of Alabama [Tuscaloosa] (UA), Instituto Salud Carlos III, Hospital La Fe, Innsbruck Medical University [Austria] (IMU), Yale University School of Medicine, Vanderbilt University [Nashville], Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), German Centre for Infection Research - partner site Hamburg-Lübeck-Borstel-Riems (DZIF), Copenhagen University Hospital-Copenhagen University Hospital, Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Università degli Studi di Milano [Milano] (UNIMI), Medical Research Council (Reino Unido), Department for International Development (Reino Unido), Unión Europea, Université de Lausanne = University of Lausanne (UNIL), Università degli Studi di Milano = University of Milan (UNIMI), Innsbruck Medical University = Medizinische Universität Innsbruck (IMU), Yale School of Medicine [New Haven, Connecticut] (YSM), German Centre for Infection Research ( DZIF ), Department of Infectious Diseases [Copenhagen], Rigshospitalet [Copenhagen]-University of Copenhagen ( KU ), Bonn Universität [Bonn], Institut Pierre Louis d'Epidémiologie et de Santé Publique ( iPLESP ), Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Université Pierre et Marie Curie - Paris 6 ( UPMC ), Université Paris Descartes - Paris 5 ( UPD5 ), Université de Lausanne ( UNIL ), Universiteit van Amsterdam ( UvA ), University of Alabama [Tuscaloosa] ( UA ), Innsbruck Medical University [Austria] ( IMU ), and Yale School of Medicine

Subjects
0301 basic medicine, RNA viruses, Male, Pediatrics, Viral Diseases, Cancer Treatment, lcsh:Medicine, HIV Infections, Pathology and Laboratory Medicine, 0302 clinical medicine, Immunodeficiency Viruses, Risk Factors, Medicine and Health Sciences, Medicine, Public and Occupational Health, 030212 general & internal medicine, Young adult, lcsh:Science, [SDV.EE]Life Sciences [q-bio]/Ecology, environment, Multidisciplinary, Transmission (medicine), Mortality rate, Viral Load, Middle Aged, Prognosis, Vaccination and Immunization, 3. Good health, AIDS, Infectious Diseases, Oncology, Medical Microbiology, Viral Pathogens, Cohort, Viruses, Female, Pathogens, Viral load, Cohort study, Research Article, Adult, medicine.medical_specialty, Adolescent, Death Rates, Anti-HIV Agents, Immunology, Antiretroviral Therapy, Microbiology, [ SDV.EE ] Life Sciences [q-bio]/Ecology, environment, 03 medical and health sciences, Young Adult, Acquired immunodeficiency syndrome (AIDS), Antiviral Therapy, Population Metrics, Diagnostic Medicine, Virology, Retroviruses, Humans, Aged, Anti-HIV Agents/pharmacology, Anti-HIV Agents/therapeutic use, Demography, HIV Infections/drug therapy, HIV Infections/mortality, HIV-1/drug effects, HIV-1/physiology, Survival Analysis, Microbial Pathogens, Survival analysis, Population Biology, business.industry, lcsh:R, Lentivirus, Organisms, Biology and Life Sciences, HIV, medicine.disease, 030112 virology, Surgery, People and Places, HIV-1, lcsh:Q, Preventive Medicine, business, Viral Transmission and Infection
Abstract

OBJECTIVES: To estimate mortality rates and prognostic factors in HIV-positive patients who started combination antiretroviral therapy between 1996-1999 and survived for more than ten years. METHODS: We used data from 18 European and North American HIV cohort studies contributing to the Antiretroviral Therapy Cohort Collaboration. We followed up patients from ten years after start of combination antiretroviral therapy. We estimated overall and cause-specific mortality rate ratios for age, sex, transmission through injection drug use, AIDS, CD4 count and HIV-1 RNA. RESULTS: During 50,593 person years 656/13,011 (5%) patients died. Older age, male sex, injecting drug use transmission, AIDS, and low CD4 count and detectable viral replication ten years after starting combination antiretroviral therapy were associated with higher subsequent mortality. CD4 count at ART start did not predict mortality in models adjusted for patient characteristics ten years after start of antiretroviral therapy. The most frequent causes of death (among 340 classified) were non-AIDS cancer, AIDS, cardiovascular, and liver-related disease. Older age was strongly associated with cardiovascular mortality, injecting drug use transmission with non-AIDS infection and liver-related mortality, and low CD4 and detectable viral replication ten years after starting antiretroviral therapy with AIDS mortality. Five-year mortality risk was

Published
2016
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47. Mortality according to CD4 count at start of combination antiretroviral therapy among HIV positive patients followed for up to 15 years after start of treatment: collaborative cohort study

Author

May, Margaret T, Vehreschild, Jorg-Janne, Trickey, Adam, Obel, Niels, Reiss, Peter, Bonnet, Fabrice, Mary-Krause, Murielle, Samji, Hasina, Cavassini, Matthias, Gill, Michael John, Shepherd, Leah C, Crane, Heidi M, d'Arminio Monforte, Antonella, Burkholder, Greer A, Johnson, Margaret M, Sobrino-Vegas, Paz, Domingo, Pere, Zangerle, Robert, Justice, Amy C, Sterling, Timothy R, Miró, José M, Sterne, Jonathan A C, Antiretroviral Therapy Cohort Collaboration (ART-CC), University of Bristol [Bristol], Universität zu Köln = University of Cologne, University of Copenhagen = Københavns Universitet (UCPH), University of Amsterdam [Amsterdam] (UvA), Academic Medical Center - Academisch Medisch Centrum [Amsterdam] (AMC), Institut de Santé Publique, d'Epidémiologie et de Développement (ISPED), Université Bordeaux Segalen - Bordeaux 2, CHU Bordeaux [Bordeaux], Institut Pierre Louis d'Epidémiologie et de Santé Publique (iPLESP), Université Pierre et Marie Curie - Paris 6 (UPMC)-Institut National de la Santé et de la Recherche Médicale (INSERM), British Columbia Centre for Excellence in HIV/AIDS, St. Paul's Hospital, Université de Lausanne = University of Lausanne (UNIL), University of Calgary, UCL Medical School, University of Washington [Seattle], 'San Paolo' Hospital, University of Alabama [Tuscaloosa] (UA), Royal Free London NHS Foundation Trust, Instituto Salud Carlos III, Universitat Autònoma de Barcelona (UAB), Universität Innsbruck [Innsbruck], Yale University [New Haven], VA Connecticut Healthcare System, Vanderbilt University [Nashville], Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Universitat de Barcelona (UB), Medical Research Council (Reino Unido), Department for International Development (Reino Unido), National Institute for Health Research (Reino Unido), Agence Nationale de Recherches sur le sida et les hépatites virales (Francia), Institut National de la Santé et de la Recherche Médicale (Francia), Ministère de la Santé (Francia), Ministero della Salute (Italia), Ministerio de Sanidad (España), Swiss National Science Foundation, Ministerio de Ciencia e Innovación (España), Red de Investigación Cooperativa en Investigación en Sida (España), Stichting HIV Monitoring (Netherlands), Unión Europea, National Institutes of Health (Estados Unidos), NIH - National Institute on Alcohol Abuse and Alcoholism (NIAAA) (Estados Unidos), United States Department of Veterans Affairs, Michael Smith Foundation for Health Research, Canadian Institutes of Health Research, Veterans Health Administration, Unión Europea. Comisión Europea. 7 Programa Marco, Government of Alberta (Canadá), Government of Columnia (Estados Unidos), Government of the United Kingdom, Abbott, Gilead Sciences (Spain), Tibotec-Upjohn, ViiV Healthcare, GlaxoSmithKline, Pfizer, Bristol-Myers Squibb, Roche, Boehringer Ingelheim Fonds, Merck, Sharp & Dohme, HAL UPMC, Gestionnaire, Antiretroviral Therapy Cohort Collaboration (ART-CC), Boulle, A., Stephan, C., Miro, JM., Cavassini, M., Chêne, G., Costagliola, D., Dabis, F., Monforte£££Antonella D'Arminio£££ AD., Del Amo, J., Van Sighem, A., Fätkenheuer, G., Gill, J., Guest, J., Haerry, DH., Hogg, R., Justice, A., Shepherd, L., Obel, N., Crane, H., Smith, C., Reiss, P., Saag, M., Sterling, T., Teira, R., Williams, M., Zangerle, R., Sterne, J., May, M., Ingle, S., Trickey, A., Universität zu Köln, University of Copenhagen = Københavns Universitet (KU), Université de Lausanne (UNIL), AII - Amsterdam institute for Infection and Immunity, APH - Amsterdam Public Health, Global Health, and Universitat de Barcelona

Subjects
0301 basic medicine, Male, Integrase inhibitor, HIV Infections, Kaplan-Meier Estimate, Cohort Studies, 0302 clinical medicine, Cohort collaboration, 030212 general & internal medicine, Lymphocytes, [SDV.MP.VIR] Life Sciences [q-bio]/Microbiology and Parasitology/Virology, education.field_of_study, Reverse-transcriptase inhibitor, Relative survival, Mortality rate, Antiretrovirals, Middle Aged, 3. Good health, Antiretroviral therapy, Infectious Diseases, Anti-Retroviral Agents, Cohort, [SDV.MP.VIR]Life Sciences [q-bio]/Microbiology and Parasitology/Virology, HIV/AIDS, Female, medicine.drug, Cohort study, Microbiology (medical), Adult, medicine.medical_specialty, Adolescent, Population, antiretroviral therapy, CD4 count, Limfòcits, 03 medical and health sciences, Young Adult, Internal medicine, medicine, VIH (Virus), Humans, Mortality, education, Survival analysis, business.industry, HIV (Viruses), cohort collaboration, HIV, mortality, Antiretroviral agents, Surgery, CD4 Lymphocyte Count, 030104 developmental biology, Morbiditat, Morbidity, business
Abstract

The strong association of CD4 count at start of combination therapy with subsequent survival in HIV-infected patients diminished during the first 5 years of treatment. After 5 years, lower baseline CD4 counts were not associated with higher mortality., Background. CD4 count at start of combination antiretroviral therapy (ART) is strongly associated with short-term survival, but its association with longer-term survival is less well characterized. Methods. We estimated mortality rates (MRs) by time since start of ART (

Published
2016
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48. Boceprevir for chronic HCV genotype 1 infection in patients with prior treatment failure to peginterferon/ribavirin, including prior null response

Author

M. Davis, Patrick Marcellin, Anita Y. M. Howe, Jean-Pierre Bronowicki, Jonathan McCone, W. Deng, Stuart C Gordon, Eric M. Yoshida, John M. Vierling, Andrew J. Muir, Lisa D. Pedicone, Frans A. Helmond, Fred Poordad, Lynn Y. Colvard, Joseph S. Galati, Ira M. Jacobson, Janice K. Albrecht, Eric Lawitz, Clifford A. Brass, Steven L. Flamm, Velimir A. Luketic, Janice Wahl, M. Treitel, Baylor College of Medicine (BCM), Baylor University, South Florida Center of Gastroenterology, Feinberg School of Medicine, Northwestern University [Evanston], Henry Ford Health System, Texas Liver Institute [San Antonio], University of Texas Health Science Center, The University of Texas Health Science Center at Houston (UTHealth)- The University of Texas Health Science Center at Houston (UTHealth), St. Paul’s Hospital - University of British Columbia [Vancouver, BC, Canada], Liver Specialists of Texas, Virginia Commonwealth University (VCU), Mount Vernon Cancer Centre, Weill Medical College of Cornell University [New York], Centre de recherche biomédicale Bichat-Beaujon (CRB3), Université Paris Diderot - Paris 7 (UPD7)-Institut National de la Santé et de la Recherche Médicale (INSERM), Division of Gastroenterology, Duke Clinical Research Institute-Duke University Medical Center, Merck Sharp & Dohme Corp. (MSD), Whitehouse Station, Nutrition-Génétique et Exposition aux Risques Environnementaux (NGERE), and Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lorraine (UL)

Subjects
Male, MedDRA, [SDV]Life Sciences [q-bio], Hepacivirus, medicine.disease_cause, Gastroenterology, Polyethylene Glycols, chemistry.chemical_compound, 0302 clinical medicine, Medicine, Treatment Failure, 030212 general & internal medicine, Relapse, Boceprevir, virus diseases, Middle Aged, Viral Load, Recombinant Proteins, 3. Good health, Sustained virological response, Treatment Outcome, Drug Therapy, Combination, Female, 030211 gastroenterology & hepatology, medicine.symptom, Viral load, Adult, medicine.medical_specialty, Genotype, Proline, Hepatitis C virus, Interferon alpha-2, Antiviral Agents, 03 medical and health sciences, Internal medicine, Drug Resistance, Viral, Ribavirin, Humans, Adverse effect, Aged, Partial response, Intention-to-treat analysis, Hepatology, business.industry, Null response, Interferon-alpha, Hepatitis C, Chronic, digestive system diseases, Surgery, Dysgeusia, chemistry, business
Abstract

International audience; BACKGROUND & AIMS:Boceprevir with peginterferon/ribavirin (BOC/PR) leads to significantly higher sustained virological response (SVR) rates in patients with chronic hepatitis C and partial response or relapse after prior treatment with peginterferon/ribavirin. We studied the efficacy of BOC/PR in patients with prior treatment failure, including those with a null response (2 weeks after end-of-treatment in the prior study received PR for 4 weeks before adding boceprevir.RESULTS:Of 168 patients enrolled, four discontinued from the PR lead-in and 164 received BOC/PR. Baseline viral load was >800,000 IU/ml in 77% of patients; 62% had HCV genotype 1a, and 10% were cirrhotic. In the ITT analysis (all 168 patients), SVR was achieved in 20 (38%) of 52 patients with prior null response, 57 (67%) of 85 with prior partial response, and 27 (93%) of 29 with prior relapse. In the mITT analysis (164 BOC/PR-treated patients), SVR rates were 41% (20/49), 67% (57/85), and 96% (27/28), respectively. SVR was achieved by 48% of patients with

Published
2014
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49. Transcatheter aortic valve replacement for degenerative bioprosthetic surgical valves: results from the global valve-in-valve registry

Author

José M. de la Torre Hernández, Nicolas Dumonteil, Jean Claude Laborde, Christian Hengstenberg, Danny Dvir, Henrik Nissen, Massimo Napodano, Andreas Baumbach, Thierry Lefèvre, Rui Campante Teles, Amit Segev, Raffi Bekeredjian, Victor Guetta, Didier Tchetche, David Roy, Neil Moat, Stephen Brecker, Federico De Marco, John G. Webb, Fleur Descoutures, Luca Testa, Antonio Colombo, Claudia Fiorina, David Hildick-Smith, Sabine Bleiziffer, Mohamed Abdel-Wahab, Ran Kornowski, Michael Gotzmann, [Dvir,D] Washington Hospital Center, Washington, USA. [Dvir,D, Kornowski,R] Rabin Medical Center and Tel-Aviv University, Tel-Aviv, Israel. [Webb,J] St. Paul's Hospital, Vancouver, British Columbia, Canada. [Brecker,S, Roy,D, Laborde,JC] St. George's Hospital, London, United Kingdom. [Bleiziffer,S] German Heart Center, Munich, Germany. [Hildick-Smith,D] Sussex Cardiac Centre, Brighton, UK. [Colombo,A] San Raffaele Scientific Institute, Milan, Italy. [Descoutures,F] Hospital Bichat, Paris, France. [Hengstenberg,C] Universitaetsklinikum Regensburg, Regensburg, Germany. [Moat,NE] Royal Brompton Hospital, London, United Kingdom. [Bekeredjian,R] University of Heidelberg, Heidelberg, Germany. [Napodano,M] Department of Cardiac, Thoracic, and Vascular Sciences, University of Padova, Padova, Italy. [Testa,L] Clinical Institute S. Ambrogio, Milan, Italy. [Lefevre,T] Hopital Jacques Cartier, Massy, France. [Guetta,V, and Sergev,A] Sheba Medical Center, Tel Hashomer, Israel. [Nissen,H] Odense University Hospital, Odense, Denmark. [Hernández,JM] Hospital Universitario Virgen de la Victoria, Málaga, Spain. [Teles,RC] Hospital de Santa Cruz, Lisboa, Portugal. [Dumonteil,N] Rangueil University Hospital, Toulouse, France. [Fiorina,C] Azienda Ospedaliere Spedali Civili di Brescia, Brescia, Italy. [Gotzmann,M] Bergmannsheil Ruhr University, Bochum, Germany. [Tchetche,D] Clinique Pasteur, Toulouse, France. [Abdel-Wahab,M] Segeberger Kliniken GmbH, Bad Segeberg, Germany. [De Marco,F] Ospedale Niguarda Ca' Granda, Milan, Italy. [Baumbach,A] Bristol Heart Institute, Bristol, United Kingdom.

Subjects
Male, Cardiac Catheterization, medicine.medical_treatment, Diseases::Cardiovascular Diseases::Heart Diseases::Heart Valve Diseases::Aortic Valve Stenosis [Medical Subject Headings], Analytical, Diagnostic and Therapeutic Techniques and Equipment::Equipment and Supplies::Prostheses and Implants::Heart Valve Prosthesis [Medical Subject Headings], Global Health, New york heart association, Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans [Medical Subject Headings], Prótesis Valvulares Cardíacas, Valve replacement, 80 and over, Medicine, Registries, Aged, 80 and over, Heart Valve Prosthesis Implantation, Incidence, Estenosis de la Válvula Aórtica, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Equipment and Supplies::Prostheses and Implants::Bioprosthesis [Medical Subject Headings], Treatment Outcome, Aortic Valve, Heart Valve Prosthesis, Diseases::Cardiovascular Diseases::Vascular Diseases::Arterial Occlusive Diseases::Arteriosclerosis::Coronary Artery Disease [Medical Subject Headings], Cardiology, Diseases::Cardiovascular Diseases::Heart Diseases::Heart Valve Diseases::Aortic Valve Insufficiency [Medical Subject Headings], Equipment Failure, Female, Insuficiencia de la Válvula Aórtica, Cardiology and Cardiovascular Medicine, Reoperation, valve-in-valve, medicine.medical_specialty, Transcatheter aortic, Resultado del Tratamiento, Aortic Valve Insufficiency, Regurgitation (circulation), Enfermedad de la Arteria Coronaria, Physiology (medical), Internal medicine, Humans, bioprosthesis, transcatheter aortic valve implantation, Aged, Aortic Valve Stenosis, Bioprosthesis, Follow-Up Studies, Retrospective Studies, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Surgical Procedures, Operative::Cardiovascular Surgical Procedures::Vascular Surgical Procedures::Endovascular Procedures::Catheterization, Central Venous [Medical Subject Headings], Analytical, Diagnostic and Therapeutic Techniques and Equipment::Diagnosis::Prognosis::Treatment Outcome [Medical Subject Headings], Transcatheter aortic valve implantation, business.industry, Cateterismo Venoso Central, Retrospective cohort study, Surgical valves, medicine.disease, Valve in valve, Surgery, Stenosis, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Surgical Procedures, Operative::Cardiovascular Surgical Procedures::Cardiac Surgical Procedures [Medical Subject Headings], Valve-in-valve, business, Implantación de Prótesis de Válvulas Cardíacas
Abstract

Background— Transcatheter aortic valve-in-valve implantation is an emerging therapeutic alternative for patients with a failed surgical bioprosthesis and may obviate the need for reoperation. We evaluated the clinical results of this technique using a large, worldwide registry. Methods and Results— The Global Valve-in-Valve Registry included 202 patients with degenerated bioprosthetic valves (aged 77.7±10.4 years; 52.5% men) from 38 cardiac centers. Bioprosthesis mode of failure was stenosis (n=85; 42%), regurgitation (n=68; 34%), or combined stenosis and regurgitation (n=49; 24%). Implanted devices included CoreValve (n=124) and Edwards SAPIEN (n=78). Procedural success was achieved in 93.1% of cases. Adverse procedural outcomes included initial device malposition in 15.3% of cases and ostial coronary obstruction in 3.5%. After the procedure, valve maximum/mean gradients were 28.4±14.1/15.9±8.6 mm Hg, and 95% of patients had ≤+1 degree of aortic regurgitation. At 30-day follow-up, all-cause mortality was 8.4%, and 84.1% of patients were at New York Heart Association functional class I/II. One-year follow-up was obtained in 87 patients, with 85.8% survival of treated patients. Conclusions— The valve-in-valve procedure is clinically effective in the vast majority of patients with degenerated bioprosthetic valves. Safety and efficacy concerns include device malposition, ostial coronary obstruction, and high gradients after the procedure.

Published
2012
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50. An Open-Label, Noncomparative, Multicenter Study to Evaluate Efficacy and Safety of NASHA/Dx Gel as a Bulking Agent for the Treatment of Fecal Incontinence

Author

Giuseppe Dodi, Donato F. Altomare, Johannes Jongen, Paul-Antoine Lehur, Fernando de la Portilla, Manoj J. Raval, and [Dodi,G] Universita degli Studi di Padova Hospital Clinica Chirurgica, Padova, Italy. [Jongen,J] Proktologische Praxis Kiel, Kiel, Germany. [de la Portilla,F] Coloproctology Section, Department of Surgery, Virgen del Rocio University Hospital,Seville, Spain. [Raval,M] St. Paul’s Hospital, Vancouver, Canada. [Altomare,DF] Coloproctological Unit of Bari Policinico di Bari Piazza, University of Bari, Bari, Italy. [Lehur,PA] Clinique Chirurgicale, chu-Hotel-Dieu, Institut des Maladies de l’Appareil Digestif, Nantes Cedex, France

Subjects
Disease specific, medicine.medical_specialty, Article Subject, Calidad de vida, Diseases::Digestive System Diseases::Gastrointestinal Diseases::Intestinal Diseases::Rectal Diseases::Fecal Incontinence [Medical Subject Headings], Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans [Medical Subject Headings], Incontinencia fecal, Quality of life, Dextranos, Anatomy::Digestive System::Gastrointestinal Tract::Intestines::Intestine, Large::Anal Canal [Medical Subject Headings], Disciplines and Occupations::Social Sciences::Quality of Life [Medical Subject Headings], medicine, Fecal incontinence, Treatment effect, lcsh:RC799-869, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Data Collection::Vital Statistics::Morbidity::Prevalence [Medical Subject Headings], Hepatology, Inyecciones, business.industry, Gastroenterology, Anal canal, Canal Anal, Surgery, Humanos, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Therapeutics::Drug Therapy::Drug Administration Routes::Injections [Medical Subject Headings], medicine.anatomical_structure, Multicenter study, lcsh:Diseases of the digestive system. Gastroenterology, medicine.symptom, Open label, business, Prevalencia, Chemicals and Drugs::Macromolecular Substances::Polymers::Biopolymers::Glucans::Dextrans [Medical Subject Headings], After treatment, Research Article
Abstract

Fecal incontinence (FI) is the involuntary loss of rectal contents through the anal canal. Reports of its prevalence vary from 1–21%. Studies, have demonstrated a positive effect on FI symptoms with injectable bulking agents. This study evaluated the safety and efficacy of NASHA/Dx gel in the treatment of FI. One hundred fifteen eligible patients suffering from FI received 4 injections of 1 mL NASHA/Dx gel. Primary efficacy was based on data from 86 patients that completed the study. This study demonstrated a ≥50% reduction from baseline in the number of FI episodes in 57.1% of patients at 6 months, and 64.0% at 12 months. Significant improvements (P<.001) were also noted in total number of both solid and loose FI episodes, FI free days, CCFIS, and FIQL scores in all 4 domains. The majority of the treatment related AEs (94.9%) were mild or moderate intensity, and (98.7%) of AEs resolved spontaneously, or following treatment, without sequelae. Results of this study indicate NASHA/Dx gel was efficacious in the treatment of FI. Treatment effect was significant both in reduction of number of FI episodes and disease specific quality of life at 6 months and lasted up to 12 months after treatment.

Published
2010
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