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Randomized Controlled Trial
. 2014 Sep 11;371(11):993-1004.
doi: 10.1056/NEJMoa1409077. Epub 2014 Aug 30.

Angiotensin-neprilysin inhibition versus enalapril in heart failure

John J V McMurray  1 , Milton Packer, Akshay S Desai, Jianjian Gong, Martin P Lefkowitz, Adel R Rizkala, Jean L Rouleau, Victor C Shi, Scott D Solomon, Karl Swedberg, Michael R Zile; PARADIGM-HF Investigators and Committees
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Randomized Controlled Trial

Angiotensin-neprilysin inhibition versus enalapril in heart failure (VSports手机版)

John J V McMurray et al. N Engl J Med. .
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"VSports" Abstract

Background: We compared the angiotensin receptor-neprilysin inhibitor LCZ696 with enalapril in patients who had heart failure with a reduced ejection fraction VSports手机版. In previous studies, enalapril improved survival in such patients. .

Methods: In this double-blind trial, we randomly assigned 8442 patients with class II, III, or IV heart failure and an ejection fraction of 40% or less to receive either LCZ696 (at a dose of 200 mg twice daily) or enalapril (at a dose of 10 mg twice daily), in addition to recommended therapy. The primary outcome was a composite of death from cardiovascular causes or hospitalization for heart failure, but the trial was designed to detect a difference in the rates of death from cardiovascular causes. V体育安卓版.

Results: The trial was stopped early, according to prespecified rules, after a median follow-up of 27 months, because the boundary for an overwhelming benefit with LCZ696 had been crossed. At the time of study closure, the primary outcome had occurred in 914 patients (21. 8%) in the LCZ696 group and 1117 patients (26. 5%) in the enalapril group (hazard ratio in the LCZ696 group, 0. 80; 95% confidence interval [CI], 0 V体育ios版. 73 to 0. 87; P<0. 001). A total of 711 patients (17. 0%) receiving LCZ696 and 835 patients (19. 8%) receiving enalapril died (hazard ratio for death from any cause, 0. 84; 95% CI, 0. 76 to 0. 93; P<0. 001); of these patients, 558 (13. 3%) and 693 (16. 5%), respectively, died from cardiovascular causes (hazard ratio, 0. 80; 95% CI, 0. 71 to 0. 89; P<0. 001). As compared with enalapril, LCZ696 also reduced the risk of hospitalization for heart failure by 21% (P<0. 001) and decreased the symptoms and physical limitations of heart failure (P=0. 001). The LCZ696 group had higher proportions of patients with hypotension and nonserious angioedema but lower proportions with renal impairment, hyperkalemia, and cough than the enalapril group. .

Conclusions: LCZ696 was superior to enalapril in reducing the risks of death and of hospitalization for heart failure. (Funded by Novartis; PARADIGM-HF ClinicalTrials. gov number, NCT01035255. ). VSports最新版本.

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