Efficacy and safety of sacubitril/valsartan compared with enalapril in patients with chronic heart failure and reduced ejection fraction: Results from PARADIGM-HF India sub-study
| Autor: | Gauri Billa, Anil Ranjeetmal Jain, Rakesh Aggarwal, Shankar Kumar, Nanyam Srinivas Rao |
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| Rok vydání: | 2020 |
| Předmět: |
Male
medicine.medical_specialty RD1-811 India Angiotensin-Converting Enzyme Inhibitors 030204 cardiovascular system & hematology Sacubitril Ventricular Function Left 03 medical and health sciences Angiotensin Receptor Antagonists 0302 clinical medicine Double-Blind Method Enalapril Internal medicine Clinical endpoint medicine Diseases of the circulatory (Cardiovascular) system Humans 030212 general & internal medicine Adverse effect Heart Failure Ejection fraction business.industry Aminobutyrates Incidence Biphenyl Compounds Indian Stroke Volume Middle Aged medicine.disease All-cause mortality HF hospitalization Survival Rate Drug Combinations Treatment Outcome Valsartan Heart failure RC666-701 Cardiology Cardiovascular death Surgery Female Original Article Cardiology and Cardiovascular Medicine business Sacubitril Valsartan medicine.drug |
| Zdroj: | Indian Heart Journal Indian Heart Journal, Vol 72, Iss 6, Pp 535-540 (2020) |
| ISSN: | 2213-3763 |
| Popis: | Objectives To determine efficacy and safety of sacubitril/valsartan compared with enalapril in Indian patients of PARADIGM-HF trial. Methods A randomized, double-blind, active-controlled, phase III sub-study (NCT01035255) was conducted between April 2010 and May 2014. Patients with chronic heart failure (HF), aged >18 years with left ventricular ejection fraction ≤40% were randomized (1:1) to receive either sacubitril/valsartan 200 mg twice-daily or enalapril 10 mg twice-daily. The primary endpoint was to compare efficacy of sacubitril/valsartan to enalapril in delaying time-to-first occurrence of the composite endpoint (cardiovascular [CV] death or HF hospitalization). Results The trial was stopped after a median follow-up of 27 months, because the boundary for benefit with sacubitril/valsartan had crossed. Among 637 Indian patients in PARADIGM-HF (sacubitril/valsartan, n = 322 and enalapril, n = 315), the primary outcome, CV death, and the first hospitalization for HF occurred in 21.81% and 24.76% (HR 0.89; 95% CI, 0.646–1.231), 17.45% and 20.63% (HR 0.87; 95% CI, 0.605–1.236), and 7.48% and 9.52% (HR 0.78; 95% CI, 0.461–1.350) patients in the sacubitril/valsartan and enalapril group, respectively. The all-cause mortality (19.0% vs. 21.9%) and adverse events (78.4% vs. 82.2%) were comparatively lower in the sacubitril/valsartan than enalapril group. No significant difference was seen between the benefits of treatment in Indian and the total PARADIGM-HF cohort (p value for interaction >0.05). Conclusion Results support the use of sacubitril/valsartan in Indian patients with chronic HF with reduced ejection fraction with treatment benefits similar to global PARADIGM-HF cohort. |
| Databáze: | OpenAIRE |
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