Loading...
Geographic variations in the PARADIGM-HF heart failure trial
Kristensen, Søren L. Martinez, Felipe Jhund, Pardeep S. Arango, Juan Luis Bĕlohlávek, Jan Boytsov, Sergey Cabrera, Walter Gomez, Efrain Hagege, Albert Alain Huang, Jun
Kristensen, Søren L.
Martinez, Felipe
Jhund, Pardeep S.
Arango, Juan Luis
Bĕlohlávek, Jan
Boytsov, Sergey
Cabrera, Walter
Gomez, Efrain
Hagege, Albert Alain
Huang, Jun
Author
Kristensen, Søren L.
Martinez, Felipe
Jhund, Pardeep S.
Arango, Juan Luis
Bĕlohlávek, Jan
Boytsov, Sergey
Cabrera, Walter
Gomez, Efrain
Hagege, Albert Alain
Huang, Jun
Kiatchoosakun, Songsak
Kim, Kee-Sik
Mendoza, Iván
Senni, Michele
Squire, Iain B.
Vinereanu, Dragos
Wong, Raymond Chiew-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.
Martinez, Felipe
Jhund, Pardeep S.
Arango, Juan Luis
Bĕlohlávek, Jan
Boytsov, Sergey
Cabrera, Walter
Gomez, Efrain
Hagege, Albert Alain
Huang, Jun
Kiatchoosakun, Songsak
Kim, Kee-Sik
Mendoza, Iván
Senni, Michele
Squire, Iain B.
Vinereanu, Dragos
Wong, Raymond Chiew-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.
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) 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.
Keywords
heart failure, treatment outcome, geographical variation, clinical trial, prognosis
Date
2016
Type
Journal article
Journal
European Heart Journal
Book
Volume
37
Issue
41
Page Range
3167-3174
Article Number
ACU Department
Collections
Relation URI
Source URL
Event URL
Open Access Status
Open access
License
File Access
Open
Notes
© The Author 2016. Published by Oxford University Press on behalf of the European Society of Cardiology. This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com