TY  - JOUR
ID  - enlighten120829
UR  - https://eprints.gla.ac.uk/120829/
IS  - 41
A1  - Kristensen, S�ren Lund
A1  - Martinez, Felipe
A1  - Jhund, Pardeep S.
A1  - Arango, Juan Luis
A1  - B?lohl�vek, Jan
A1  - Boytsov, Sergey
A1  - Cabrera, Walter
A1  - Gomez, Efrain
A1  - Hag�ge, Albert A.
A1  - Huang, Jun
A1  - Kiatchoosakun, Songsak
A1  - Kim, Kee-Sik
A1  - Mendoza, Iv�n
A1  - Senni, Michele
A1  - Squire, Iain B.
A1  - Vinereanu, Dragos
A1  - Wong, Raymond Ching-Chiew
A1  - Gong, Jianjian
A1  - Lefkowitz, Martin P.
A1  - Rizkala, Adel R.
A1  - Rouleau, Jean L.
A1  - Shi, Victor C.
A1  - Solomon, Scott D.
A1  - Swedberg, Karl
A1  - Zile, Michael R.
A1  - Packer, Milton
A1  - McMurray, John J.V.
Y1  - 2016///
N2  - 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.
PB  - Oxford University Press
JF  - European Heart Journal
VL  - 37
SN  - 0195-668X
TI  - Geographic variations in the PARADIGM-HF heart failure trial
SP  - 3167
AV  - public
EP  - 3174
ER  -