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1. Initiation of sacubitril/valsartan in haemodynamically stabilised heart failure patients in hospital or early after discharge: primary results of the randomised TRANSITION study

Author

Wachter, R, Senni, M, Belohlavek, J, Straburzynska-Migaj, E, Witte, K, Kobalava, Z, Fonseca, C, Goncalvesova, E, Cavusoglu, Y, Fernandez, A, Chaaban, S, Bøhmer, E, Pouleur, A, Mueller, C, Tribouilloy, C, Lonn, E, A L Buraiki, J, Gniot, J, Mozheiko, M, Lelonek, M, Noè, A, Schwende, H, Bao, W, Butylin, D, Pascual-Figal, D, Transition, I, Wachter R, Senni M, Belohlavek J, Straburzynska-Migaj E, Witte KK, Kobalava Z, Fonseca C, Goncalvesova E, Cavusoglu Y, Fernandez A, Chaaban S, Bøhmer E, Pouleur AC, Mueller C, Tribouilloy C, Lonn E, A L Buraiki J, Gniot J, Mozheiko M, Lelonek M, Noè A, Schwende H, Bao W, Butylin D, Pascual-Figal D, TRANSITION Investigators, Wachter, R, Senni, M, Belohlavek, J, Straburzynska-Migaj, E, Witte, K, Kobalava, Z, Fonseca, C, Goncalvesova, E, Cavusoglu, Y, Fernandez, A, Chaaban, S, Bøhmer, E, Pouleur, A, Mueller, C, Tribouilloy, C, Lonn, E, A L Buraiki, J, Gniot, J, Mozheiko, M, Lelonek, M, Noè, A, Schwende, H, Bao, W, Butylin, D, Pascual-Figal, D, Transition, I, Wachter R, Senni M, Belohlavek J, Straburzynska-Migaj E, Witte KK, Kobalava Z, Fonseca C, Goncalvesova E, Cavusoglu Y, Fernandez A, Chaaban S, Bøhmer E, Pouleur AC, Mueller C, Tribouilloy C, Lonn E, A L Buraiki J, Gniot J, Mozheiko M, Lelonek M, Noè A, Schwende H, Bao W, Butylin D, Pascual-Figal D, and TRANSITION Investigators

Abstract

Aims: To assess tolerability and optimal time point for initiation of sacubitril/valsartan in patients stabilised after acute heart failure (AHF). Methods and results: TRANSITION was a randomised, multicentre, open-label study comparing two treatment initiation modalities of sacubitril/valsartan. Patients aged ≥ 18 years, hospitalised for AHF were stratified according to pre-admission use of renin–angiotensin–aldosterone system inhibitors and randomised (n = 1002) after stabilisation to initiate sacubitril/valsartan either ≥ 12-h pre-discharge or between Days 1–14 post-discharge. Starting dose (as per label) was 24/26 mg or 49/51 mg bid with up- or down-titration based on tolerability. The primary endpoint was the proportion of patients attaining 97/103 mg bid target dose after 10 weeks. Median time of first dose of sacubitril/valsartan from. the day of discharge was Day –1 and Day +1 in the pre-discharge group and the post-discharge group, respectively. Comparable proportions of patients in the pre- and post-discharge initiation groups met the primary endpoint [45.4% vs. 50.7%; risk ratio (RR) 0.90; 95% confidence interval (CI) 0.79–1.02]. The proportion of patients who achieved and maintained for ≥ 2 weeks leading to Week 10, either 49/51 or 97/103 mg bid was 62.1% vs. 68.5% (RR 0.91; 95% CI 0.83–0.99); or any dose was 86.0% vs. 89.6% (RR 0.96; 95% CI 0.92–1.01). Discontinuation due to adverse events occurred in 7.3% vs. 4.9% of patients (RR 1.49; 95% CI 0.90–2.46). Conclusions: Initiation of sacubitril/valsartan in a wide range of heart failure with reduced ejection fraction patients stabilised after an AHF event, either in hospital or shortly after discharge, is feasible with about half of the patients achieving target dose within 10 weeks. Clinical Trial Registration: ClinicalTrials.gov ID: NCT02661217.

Published
2019

2. Initiation of sacubitril/valsartan in haemodynamically stabilised heart failure patients in hospital or early after discharge: primary results of the randomised TRANSITION study

Author

Wachter, Rolf, Senni, Michele, Belohlavek, Jan, Straburzynska‐Migaj, Ewa, Witte, Klaus K., Kobalava, Zhanna, Fonseca, Candida, Goncalvesova, Eva, Cavusoglu, Yuksel, Fernandez, Alberto, Chaaban, Said, Bøhmer, Ellen, Pouleur, Anne‐Catherine, Mueller, Christian, Tribouilloy, Christophe, Lonn, Eva, A.L. Buraiki, Jehad, Gniot, Jacek, Mozheiko, Maria, Lelonek, Malgorzata, Noè, Adele, Schwende, Heike, Bao, Weibin, Butylin, Dmytro, Pascual‐Figal, Domingo, Dominguez, Antonio Reyes, Horacek, Thomas, del Rio, Enrique Garcia, Mueller, Christian Eugen, Straburzynska-Migaj, Ewa, Slanina, Miroslav, vom Dahl, Juergen, Ryding, Alisdair, Moriarty, Andrew, Robles, Manuel Beltran, Villota, Julio Nunez, Quintana, Antonio Garcia, Nitschke, Thorsten, Manuel Garcia Pinilla, Jose, Bonet, Luis Almenar, Filali zaatari, MD, Samia, Spinar, Jindrich, Musial, Wlodzimierz, Abdelbaki, Khaled, Fehske, Wolfgang, Bott, Michael Carlos, Hoegalmen, Geir, Leiro, Marisa Crespo, Ozcan, Ismail Turkay, Mullens, Wilfried, Kryza, Radim, Al-Ani, Riadh, Loboz-Grudzien, Krystyna, Ermoshkina, Lyudmila, Hojerova, Silvia, Fernandez, Alberto Alfredo, Spinarova, Lenka, Lapp, Harald, Bulut, Efraim, Almeida, Filipa, Vishnevsky, Alexander, Belicova, Margita, Pascual, Domingo, Witte, Klaus, Wong, Kenneth, Droogne, Walter, Delforge, Marc, Peterka, Martin, Olbrich, Hans‐Georg, Carugo, Stefano, Nessler, Jadwiga, McGill, Thao Huynh, Huegl, Burkhard, Akin, Ibrahim, Moreira, Ilidio, Baglikov, Andrey, Thambyrajah, Jeetendra, Hayes, Chris, Barrionuevo, Marcelo Raul, Yigit, Zerrin, Kaya, Hakki, Klimsa, Zdenek, Radvan, Martin, Kadel, Christoph, Landmesser, Ulf, Di Tano, Giuseppe, Lisik, Malgorzata Buksinska, Oliveira, Luis, Marques, Irene, Santos, Luis Miguel, Lenner, Egon, Letavay, Peter, Bueno, Manuel Gomez, Mota, Paula, Wong, Aaron, Bailey, Kristian, Foley, Paul, Hasbani, Eduardo, Virani, Sean, Massih, Tony Abdel, Al‐Saif, Shukri, Taborsky, Milos, Kaislerova, Marta, Motovska, Zuzana, Praha, Cohen, Aron Ariel, Logeart, Damien, Endemann, Dierk, Ferreira, Daniel, Brito, Dulce, Kycina, Peter, Bollano, Entela, Basilio, Enrique Galve, Rubio, Lorenzo Facila, Aguado, Marcos Garcia, Schiavi, Lilia Beatriz, Zivano, Daniel Francisco, Sayed, Ali El, Heyse, Alex, Schee, Alexandr, Polasek, Rostislav, Houra, Marek, Seronde, Marie France, Galinier, Michel, Noutsias, Michel, Schwimmbeck, Peter, Voigt, Ingo, Westermann, Dirk, Pulignano, Giovanni, Vegsundvaag, Johnny, Alexandre Da Silva Antunes, Jose, Monteiro, Pedro, Stevlik, Jan, Hulkoova, Beata, Juan Castro Fernandez, Antonio, Davies, Ceri, Squire, Iain, Meyer, Philippe, Sheppard, Richard, Sahin, Tayfun, Sochor, Karel, De Geeter, Guillaume, Schmeisser, Alexander, Weil, Joachim, Soares, Ana Oliveira, Vasilevna, Olga Bulashova, Oshurkov, Andrey, Sunderland, Shahid Junejo, Glover, Jason, Exequiel, Tomas, Decoulx, Eric, Meyer, Sven, Muenzel, Thomas, Frioes, Fernando, Arbolishvili, Georgy, Tokarcikova, Anna, Karlstrom, Patric, Carles Trullas Vila, Joan, Perez, Gonzalo Pena, Sankaranarayanan, Rajiv, Nageh, Thuraia, Alasia, Diego Cristian, Refaat, Marwan, Demirkan, Burcu, Al-Buraiki, Jehad, Karabsheh, Shadi, UCL - SSS/IREC/CARD - Pôle de recherche cardiovasculaire, UCL - (SLuc) Service de pathologie cardiovasculaire, Wachter, R, Senni, M, Belohlavek, J, Straburzynska-Migaj, E, Witte, K, Kobalava, Z, Fonseca, C, Goncalvesova, E, Cavusoglu, Y, Fernandez, A, Chaaban, S, Bøhmer, E, Pouleur, A, Mueller, C, Tribouilloy, C, Lonn, E, A L Buraiki, J, Gniot, J, Mozheiko, M, Lelonek, M, Noè, A, Schwende, H, Bao, W, Butylin, D, Pascual-Figal, D, and Transition, I

Subjects
Male, medicine.medical_specialty, Acute decompensated heart failure, Tetrazoles, Heart failure, 030204 cardiovascular system & hematology, Sacubitril, 03 medical and health sciences, Angiotensin Receptor Antagonists, 0302 clinical medicine, Internal medicine, medicine, Clinical endpoint, Hospitalisation, Humans, Sacubitril/valsartan, Aged, Angiotensin receptor–neprilysin inhibitor, Heart Failure, Ejection fraction, Dose-Response Relationship, Drug, business.industry, Aminobutyrates, Biphenyl Compounds, Hemodynamics, medicine.disease, Angiotensin receptor-neprilysin inhibitor, Patient Discharge, 3. Good health, Discontinuation, Drug Combinations, Treatment Outcome, Valsartan, Tolerability, Female, Neprilysin, business, Cardiology and Cardiovascular Medicine, Sacubitril, Valsartan, medicine.drug, Follow-Up Studies
Abstract

AIMS: To assess tolerability and optimal time point for initiation of sacubitril/valsartan in patients stabilised after acute heart failure (AHF). METHODS AND RESULTS: TRANSITION was a randomised, multicentre, open-label study comparing two treatment initiation modalities of sacubitril/valsartan. Patients aged ≥ 18 years, hospitalised for AHF were stratified according to pre-admission use of renin-angiotensin-aldosterone system inhibitors and randomised (n = 1002) after stabilisation to initiate sacubitril/valsartan either ≥ 12-h pre-discharge or between Days 1-14 post-discharge. Starting dose (as per label) was 24/26 mg or 49/51 mg bid with up- or down-titration based on tolerability. The primary endpoint was the proportion of patients attaining 97/103 mg bid target dose after 10 weeks. Median time of first dose of sacubitril/valsartan from the day of discharge was Day -1 and Day +1 in the pre-discharge group and the post-discharge group, respectively. Comparable proportions of patients in the pre- and post-discharge initiation groups met the primary endpoint [45.4% vs. 50.7%; risk ratio (RR) 0.90; 95% confidence interval (CI) 0.79-1.02]. The proportion of patients who achieved and maintained for ≥ 2 weeks leading to Week 10, either 49/51 or 97/103 mg bid was 62.1% vs. 68.5% (RR 0.91; 95% CI 0.83-0.99); or any dose was 86.0% vs. 89.6% (RR 0.96; 95% CI 0.92-1.01). Discontinuation due to adverse events occurred in 7.3% vs. 4.9% of patients (RR 1.49; 95% CI 0.90-2.46). CONCLUSIONS: Initiation of sacubitril/valsartan in a wide range of heart failure with reduced ejection fraction patients stabilised after an AHF event, either in hospital or shortly after discharge, is feasible with about half of the patients achieving target dose within 10 weeks. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT02661217. © 2019 The Authors. European Journal of Heart Failure published by John Wiley & Sons peerReviewed

Published
2019

3. Initiation of sacubitril/valsartan in haemodynamically stabilised heart failure patients in hospital or early after discharge: primary results of the randomised TRANSITION study.

Author

Wachter R, Senni M, Belohlavek J, Straburzynska-Migaj E, Witte KK, Kobalava Z, Fonseca C, Goncalvesova E, Cavusoglu Y, Fernandez A, Chaaban S, Bøhmer E, Pouleur AC, Mueller C, Tribouilloy C, Lonn E, A L Buraiki J, Gniot J, Mozheiko M, Lelonek M, Noè A, Schwende H, Bao W, Butylin D, and Pascual-Figal D

Subjects
Aged, Angiotensin Receptor Antagonists administration & dosage, Biphenyl Compounds, Dose-Response Relationship, Drug, Drug Combinations, Female, Follow-Up Studies, Heart Failure physiopathology, Hemodynamics drug effects, Humans, Male, Neprilysin, Treatment Outcome, Valsartan, Aminobutyrates administration & dosage, Heart Failure drug therapy, Hemodynamics physiology, Patient Discharge trends, Tetrazoles administration & dosage
Abstract

Aims: To assess tolerability and optimal time point for initiation of sacubitril/valsartan in patients stabilised after acute heart failure (AHF)., Methods and Results: TRANSITION was a randomised, multicentre, open-label study comparing two treatment initiation modalities of sacubitril/valsartan. Patients aged ≥ 18 years, hospitalised for AHF were stratified according to pre-admission use of renin-angiotensin-aldosterone system inhibitors and randomised (n = 1002) after stabilisation to initiate sacubitril/valsartan either ≥ 12-h pre-discharge or between Days 1-14 post-discharge. Starting dose (as per label) was 24/26 mg or 49/51 mg bid with up- or down-titration based on tolerability. The primary endpoint was the proportion of patients attaining 97/103 mg bid target dose after 10 weeks. Median time of first dose of sacubitril/valsartan from the day of discharge was Day -1 and Day +1 in the pre-discharge group and the post-discharge group, respectively. Comparable proportions of patients in the pre- and post-discharge initiation groups met the primary endpoint [45.4% vs. 50.7%; risk ratio (RR) 0.90; 95% confidence interval (CI) 0.79-1.02]. The proportion of patients who achieved and maintained for ≥ 2 weeks leading to Week 10, either 49/51 or 97/103 mg bid was 62.1% vs. 68.5% (RR 0.91; 95% CI 0.83-0.99); or any dose was 86.0% vs. 89.6% (RR 0.96; 95% CI 0.92-1.01). Discontinuation due to adverse events occurred in 7.3% vs. 4.9% of patients (RR 1.49; 95% CI 0.90-2.46)., Conclusions: Initiation of sacubitril/valsartan in a wide range of heart failure with reduced ejection fraction patients stabilised after an AHF event, either in hospital or shortly after discharge, is feasible with about half of the patients achieving target dose within 10 weeks., Clinical Trial Registration: ClinicalTrials.gov ID: NCT02661217., (© 2019 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)

Published
2019
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