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Title: Geographic variations in the PARADIGM-HF heart failure trial
Authors: Kristensen, Søren Lund
Martinez, Felipe
Jhund, Pardeep S.
Arango, Juan Luis
Bĕlohlávek, Jan
Boytsov, Sergey
Cabrera, Walter
Gomez, Efrain
Hagège, Albert A.
Huang, Jun
Kiatchoosakun, Songsak
Kim, Kee-Sik
Mendoza, Iván
Senni, Michele
Squire, Iain B.
Vinereanu, Dragos
Wong, Raymond Ching-Chiew
Gong, Jianjian
Lefkowitz, Martin P.
Rizkala, Adel R.
Rouleau, Jean L.
Shi, Victor C.
Solomon, Scott D.
Swedberg, Karl
Zile, Michael R.
Packer, Milton
McMurray, John J.V.
First Published: 28-Jun-2016
Publisher: Oxford University Press (OUP)
Citation: European Heart Journal, 2016, 37 (41), pp. 3167-3174
Abstract: 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) 622 (8%), Western Europe (WE) 1680 (20%), Central/Eastern Europe/Russia (CEER) 2762 (33%), Latin America (LA) 1413 (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 (53 vs. 2% AP) and least likely prescribed a mineralocorticoid receptor antagonist (36 vs. 61% 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 13.5 (95% CI 11.7-15.6), 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: Unique identifier: NCT01035255.
DOI Link: 10.1093/eurheartj/ehw226
ISSN: 0195-668X
eISSN: 1522-9645
Version: Publisher Version
Status: Peer-reviewed
Type: Journal Article
Rights: Copyright © the authors, 2016. This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-commercial License (, which permits unrestricted use, distribution, and reproduction in any medium non-commercially, provided the original author and source are credited.
Appears in Collections:Published Articles, Dept. of Cardiovascular Sciences

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