Please use this identifier to cite or link to this item: http://hdl.handle.net/2445/175935
Title: Angiotensin-Neprilysin inhibition in heart failure with preserved ejection fraction
Author: Solomon, Scott D.
McMurray, John J.V.
Anand, Inder S.
Ge, Junbo
Lam, Carolyn S.P.
Maggioni, Aldo P.
Martinez, Felipe
Packer, Milton
Pfeffer, Marc A.
Pieske, Burkert
Redfield, Margaret M.
Rouleau, Jean L.
van Veldhuisen, Dirk J.
Zannad, Faiez
Zile, Michael R.
Desai, Akshay S.
Claggett, Brian
Jhund, Pardeep S.
Boytsov, Sergey A.
Comín Colet, Josep
Cleland, John
Düngen, Hans-Dirk
Goncalvesova, Eva
Katova, Tzvetana
Kerr Saraiva, Jose F.
Lelonek, Mał
gorzata
Merkely, Bela
Senni, Michele
Shah, Sanjiv J.
Zhou, Jingmin
Rizkala, Adel R.
Gong, Jianjian
Shi, Victor C.
Lefkowitz, Martin P.
Keywords: Angiotensines
Mortalitat
Insuficiència cardíaca
Malalts hospitalitzats
Angiotensins
Mortality
Heart failure
Hospital patients
Issue Date: 24-Oct-2019
Publisher: Massachusetts Medical Society
Abstract: Background: the angiotensin receptor-neprilysin inhibitor sacubitril-valsartan led to a reduced risk of hospitalization for heart failure or death from cardiovascular causes among patients with heart failure and reduced ejection fraction. The effect of angiotensin receptor-neprilysin inhibition in patients with heart failure with preserved ejection fraction is unclear. Methods: we randomly assigned 4822 patients with New York Heart Association (NYHA) class II to IV heart failure, ejection fraction of 45% or higher, elevated level of natriuretic peptides, and structural heart disease to receive sacubitril-valsartan (target dose, 97 mg of sacubitril with 103 mg of valsartan twice daily) or valsartan (target dose, 160 mg twice daily). The primary outcome was a composite of total hospitalizations for heart failure and death from cardiovascular causes. Primary outcome components, secondary outcomes (including NYHA class change, worsening renal function, and change in Kansas City Cardiomyopathy Questionnaire [KCCQ] clinical summary score [scale, 0 to 100, with higher scores indicating fewer symptoms and physical limitations]), and safety were also assessed. Results: there were 894 primary events in 526 patients in the sacubitril-valsartan group and 1009 primary events in 557 patients in the valsartan group (rate ratio, 0.87; 95% confidence interval [CI], 0.75 to 1.01; P = 0.06). The incidence of death from cardiovascular causes was 8.5% in the sacubitril-valsartan group and 8.9% in the valsartan group (hazard ratio, 0.95; 95% CI, 0.79 to 1.16); there were 690 and 797 total hospitalizations for heart failure, respectively (rate ratio, 0.85; 95% CI, 0.72 to 1.00). NYHA class improved in 15.0% of the patients in the sacubitril-valsartan group and in 12.6% of those in the valsartan group (odds ratio, 1.45; 95% CI, 1.13 to 1.86); renal function worsened in 1.4% and 2.7%, respectively (hazard ratio, 0.50; 95% CI, 0.33 to 0.77). The mean change in the KCCQ clinical summary score at 8 months was 1.0 point (95% CI, 0.0 to 2.1) higher in the sacubitril-valsartan group. Patients in the sacubitril-valsartan group had a higher incidence of hypotension and angioedema and a lower incidence of hyperkalemia. Among 12 prespecified subgroups, there was suggestion of heterogeneity with possible benefit with sacubitril-valsartan in patients with lower ejection fraction and in women. Conclusions: sacubitril-valsartan did not result in a significantly lower rate of total hospitalizations for heart failure and death from cardiovascular causes among patients with heart failure and an ejection fraction of 45% or higher. (Funded by Novartis; PARAGON-HF ClinicalTrials.gov number, NCT01920711.).
Note: Reproducció del document publicat a: https://doi.org/10.1056/NEJMoa1908655
It is part of: New England Journal of Medicine, 2019, vol. 381, num. 17, p. 1609-1620
URI: http://hdl.handle.net/2445/175935
Related resource: https://doi.org/10.1056/NEJMoa1908655
ISSN: 0028-4793
Appears in Collections:Articles publicats en revistes (Ciències Clíniques)

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