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Initiation of sacubitril/valsartan in haemodynamically stabilised heart failure patients in hospital or early after discharge: primary results of the randomised TRANSITION study
R. Wachter, M. Senni, J. Belohlavek, E. Straburzynska-Migaj, KK. Witte, Z. Kobalava, C. Fonseca, E. Goncalvesova, Y. Cavusoglu, A. Fernandez, S. Chaaban, E. Bøhmer, AC. Pouleur, C. Mueller, C. Tribouilloy, E. Lonn, J. A L Buraiki, J. Gniot, M....
Jazyk angličtina Země Velká Británie
Typ dokumentu časopisecké články, multicentrická studie, randomizované kontrolované studie, práce podpořená grantem
Grantová podpora
NIHR-CS-012-032
Department of Health - United Kingdom
Novartis - International
NLK
Medline Complete (EBSCOhost)
od 2000-03-01 do Před 1 rokem
Wiley Free Content
od 1999 do Před 1 rokem
PubMed
31134724
DOI
10.1002/ejhf.1498
Knihovny.cz E-zdroje
- MeSH
- aminobutyráty aplikace a dávkování MeSH
- antagonisté receptorů pro angiotenzin aplikace a dávkování MeSH
- fixní kombinace léků MeSH
- hemodynamika účinky léků fyziologie MeSH
- lidé MeSH
- následné studie MeSH
- neprilysin MeSH
- propuštění pacienta trendy MeSH
- senioři MeSH
- srdeční selhání farmakoterapie patofyziologie MeSH
- tetrazoly aplikace a dávkování MeSH
- výsledek terapie MeSH
- vztah mezi dávkou a účinkem léčiva MeSH
- Check Tag
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
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.
1st Department of Cardiology University of Medical Sciences Poznan Poland
Cardiology Division Cardiovascular Department Papa Giovanni XXIII Hospital Bergamo Italy
Cardiology Division Cliniques Universitaires Saint Luc Brussels Belgium
Department of Cardiology Amiens University Hospital Amiens France
Department of Noninvasive Cardiology Medical University of Lodz Lodz Poland
Eskişehir Osmangazi University Medical Faculty Eskişehir Turkey
General Teaching Hospital Charles University Prague Prague Czech Republic
Hammoud Hospital University Medical Center Saida Lebanon
Innlandet Hospital Trust Lillehammer Norway
King Faisal Specialist Hospital Riyadh Saudi Arabia
Leeds Institute of Cardiovascular and Metabolic Medicine University of Leeds Leeds UK
McMaster University and Hamilton Health Sciences Hamilton Canada
Novartis Pharma AG Basel Switzerland
Novartis Pharmaceuticals East Hanover NJ USA
Odd Srdcovehozlyhavania a Transplantacie Bratislava Slovakia
Peoples' Friendship University of Russia Moscow Russia
Sanatorio Modelo Quilmes Buenos Aires Argentina
SP ZOZ Szpital Specjalistyczny Pulawy Poland
University Hospital Basel University of Basel Basel Switzerland
Yaroslavl Regional Hospital of Veterans of Wars Yaroslavl Russia
Citace poskytuje Crossref.org
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- $a Wachter, Rolf $u Clinic and Policlinic for Cardiology, University Hospital Leipzig, and Clinic for Cardiology, University Medicine Göttingen and German Cardiovascular Research Center, Partner Site, Göttingen, Germany.
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- $a Initiation of sacubitril/valsartan in haemodynamically stabilised heart failure patients in hospital or early after discharge: primary results of the randomised TRANSITION study / $c R. Wachter, M. Senni, J. Belohlavek, E. Straburzynska-Migaj, KK. Witte, Z. Kobalava, C. Fonseca, E. Goncalvesova, Y. Cavusoglu, A. Fernandez, S. Chaaban, E. Bøhmer, AC. Pouleur, C. Mueller, C. Tribouilloy, E. Lonn, J. A L Buraiki, J. Gniot, M. Mozheiko, M. Lelonek, A. Noè, H. Schwende, W. Bao, D. Butylin, D. Pascual-Figal, TRANSITION Investigators,
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- $a 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.
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