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Geographic variations in the PARADIGM-HF heart failure trial
SL. Kristensen, F. Martinez, PS. Jhund, JL. Arango, J. Bĕlohlávek, S. Boytsov, W. Cabrera, E. Gomez, AA. Hagège, J. Huang, S. Kiatchoosakun, KS. Kim, I. Mendoza, M. Senni, IB. Squire, D. Vinereanu, RC. Wong, J. Gong, MP. Lefkowitz, AR. Rizkala,...
Language English Country England, Great Britain
Document type Journal Article
NLK
Free Medical Journals
from 1996 to 1 year ago
Open Access Digital Library
from 1996-01-01
- MeSH
- Hospitalization MeSH
- Middle Aged MeSH
- Humans MeSH
- Aged MeSH
- Heart Failure * MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Aged MeSH
- Publication type
- Journal Article MeSH
- Geographicals
- Asia MeSH
- Europe MeSH
AIMS: The globalization of clinical trials has highlighted geographic variations in patient characteristics, event rates, and treatment effects. We investigated these further in PARADIGM-HF, the largest and most globally representative trial in heart failure (HF) to date. METHODS AND RESULTS: We looked at five regions: North America (NA) 602 (8%), Western Europe (WE) 1680 (20%), Central/Eastern Europe/Russia (CEER) 2762 (33%), Latin America (LA) 1433 (17%), and Asia-Pacific (AP) 1487 (18%). Notable differences included: WE patients (mean age 68 years) and NA (65 years) were older than AP (58 years) and LA (63 years) and had more coronary disease; NA and CEER patients had the worst signs, symptoms, and functional status. North American patients were the most likely to have a defibrillating-device (54 vs. 2% AP) and least likely prescribed a mineralocorticoid receptor antagonist (36 vs. 65% LA). Other evidence-based therapies were used most frequently in NA and WE. Rates of the primary composite outcome of cardiovascular (CV) death or HF hospitalization (per 100 patient-years) varied among regions: NA 13.6 (95% CI 11.7-15.7) WE 9.6 (8.6-10.6), CEER 12.3 (11.4-13.2), LA 11.2 (10.0-12.5), and AP 12.5 (11.3-13.8). After adjustment for prognostic variables, relative to NA, the risk of CV death was higher in LA and AP and the risk of HF hospitalization lower in WE. The benefit of sacubitril/valsartan was consistent across regions. CONCLUSION: There were many regional differences in PARADIGM-HF, including in age, symptoms, comorbidity, background therapy, and event-rates, although these did not modify the benefit of sacubitril/valsartan. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT01035255.
1st Affiliated Hospital with Nanjing Medical University Nanjing China
Assistance Publique Hôpitaux de Paris Hôpital Européen Georges Pompidou Département de Cardiologie
Azienda Ospedaliera Papa Giovanni XXIII Cardiologia 1 Scompenso e Trapianti di Cuore Bergamo Italy
Baylor Heart and Vascular Institute Baylor University Medical Center Dallas TX USA
Brigham and Women's Hospital Boston MA USA
Cardiology Medicine Khon Kaen University Khon Kaen Thailand
Daegu Catholic University Hospital Daegu Korea
Department of Cardiology National University Heart Centre Singapore
Emeritus Professor of Medicine Universidad Nacional of Cordoba Cordoba Argentina
Guatemalan Heart Institute Guatemala
INSERM U970 Paris Cardiovascular Research Center Paris France
Institut de Cardiologie de Montréal Université de Montréal Montreal Canada
National Research Center for Preventive Medicine Moscow Russia
Novartis Pharmaceuticals East Hanover New Jersey USA
Paris Descartes University Sorbonne Paris Cité
University of Medicine and Pharmacy Carol Davila University and Emergency Hospital Bucharest Romania
Venezuela Instituto Tropical Medicine Universidad Central Venezuela Caracas Venezuela
References provided by Crossref.org
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- $a Kristensen, Søren Lund $u BHF Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow G12 8TA, UK john.mcmurray@glasgow.ac.uk. Department of Cardiology, Rigshospitalet, Copenhagen, Denmark.
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