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- PMID: 25176015
- UKPMCID: 25176015
- DOI: 10.1056/NEJMoa1409077
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Angiotensin-neprilysin inhibition versus enalapril in heart failure.
McMurray, John J V; Packer, Milton; Desai, Akshay S; Gong, Jianjian; Lefkowitz, Martin P; Rizkala, Adel R; Rouleau, Jean L; Shi, Victor C; Solomon, Scott D; Swedberg, Karl; Zile, Michael R;
The New England journal of medicine. 2014;371(11):993-1004.
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Full-text held externally
- PMID: 25176015
- UKPMCID: 25176015
- DOI: 10.1056/NEJMoa1409077
Abstract
BACKGROUND: We compared the angiotensin receptor-neprilysin inhibitor LCZ696 with enalapril in patients who had heart failure with a reduced ejection fraction. 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. 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], 0.73 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.).
Bibliographic metadata
- McMurray, John
- Packer, Milton
- Rouleau, Jean
- Solomon, Scott
- Swedberg, Karl
- Zile, Michael
- Lefkowitz, Martin
- Martinez, Felipe
- Vanhaecke, Johan
- Ramires, Felix
- Katova, Tzvetana
- Arnold, Malcolm
- Huang, Jun
- Gomez, Efrain
- Belohlavek, Jan
- Refsgaard, Jens
- Lederballe, Ole
- Gonzalez, Angel
- Duarte, Yan Carlo
- Rosenthal, Arvo
- Peuhkurinen, Keijo
- Hagege, Alber-Alain
- Böhm, Michael
- Arango, Juan Luis
- Merkely, Bela
- Andersen, Karl
- Senni, Michele
- Erglis, Andrejs
- Petrulioniene, Zaneta
- Llamas, Edmundo Bayram
- Mosterd, Arend
- Cabrera, Walter
- Sibulo, Antonio S
- Negrusz-Kawecka, Marta
- Silva-Cardoso, José
- Vinereanu, Dragos
- Boytsov, Sergey
- Wong, Raymond
- Dukat, Andrej
- Burgess, Lesley
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- Squire, Iain
- Starling, Randall
- Teerlink, John
- Dargie, Henry
- Foley, Robert
- Francis, Gary S
- Komajda, Michel
- Pocock, Stuart
- Solomon, Scott
- Desai, Akshay S
- Barkoudah, Ebrahim
- Bello, Natalie
- Brahimi, Abdel
- Charytan, David
- Duong, Chau
- Finn, Peter
- Hartley, Howard
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