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Angiotensin-Neprilysin Inhibition in Heart Failure with Preserved Ejection Fraction.
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; Comin-Colet, Josep; Cleland, John; Düngen, Hans-Dirk; Goncalvesova, Eva; Katova, Tzvetana; Kerr Saraiva, Jose F; Lelonek, Malgorzata; Merkely, Bela; Senni, Michele; Shah, Sanjiv J; Zhou, Jingmin; Rizkala, Adel R; Gong, Jianjian; Shi, Victor C; Lefkowitz, Martin P.
Affiliation
  • Solomon SD; From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (S.D.S., M.A.P., A.S.D., B.C.); the British Heart Foundation Cardiovascular Research Centre (J.J.V.M., P.S.J.) and the Robertson Centre for Biostatistics and Clinical Trials, Institute of Health and Well-b
  • McMurray JJV; From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (S.D.S., M.A.P., A.S.D., B.C.); the British Heart Foundation Cardiovascular Research Centre (J.J.V.M., P.S.J.) and the Robertson Centre for Biostatistics and Clinical Trials, Institute of Health and Well-b
  • Anand IS; From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (S.D.S., M.A.P., A.S.D., B.C.); the British Heart Foundation Cardiovascular Research Centre (J.J.V.M., P.S.J.) and the Robertson Centre for Biostatistics and Clinical Trials, Institute of Health and Well-b
  • Ge J; From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (S.D.S., M.A.P., A.S.D., B.C.); the British Heart Foundation Cardiovascular Research Centre (J.J.V.M., P.S.J.) and the Robertson Centre for Biostatistics and Clinical Trials, Institute of Health and Well-b
  • Lam CSP; From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (S.D.S., M.A.P., A.S.D., B.C.); the British Heart Foundation Cardiovascular Research Centre (J.J.V.M., P.S.J.) and the Robertson Centre for Biostatistics and Clinical Trials, Institute of Health and Well-b
  • Maggioni AP; From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (S.D.S., M.A.P., A.S.D., B.C.); the British Heart Foundation Cardiovascular Research Centre (J.J.V.M., P.S.J.) and the Robertson Centre for Biostatistics and Clinical Trials, Institute of Health and Well-b
  • Martinez F; From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (S.D.S., M.A.P., A.S.D., B.C.); the British Heart Foundation Cardiovascular Research Centre (J.J.V.M., P.S.J.) and the Robertson Centre for Biostatistics and Clinical Trials, Institute of Health and Well-b
  • Packer M; From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (S.D.S., M.A.P., A.S.D., B.C.); the British Heart Foundation Cardiovascular Research Centre (J.J.V.M., P.S.J.) and the Robertson Centre for Biostatistics and Clinical Trials, Institute of Health and Well-b
  • Pfeffer MA; From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (S.D.S., M.A.P., A.S.D., B.C.); the British Heart Foundation Cardiovascular Research Centre (J.J.V.M., P.S.J.) and the Robertson Centre for Biostatistics and Clinical Trials, Institute of Health and Well-b
  • Pieske B; From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (S.D.S., M.A.P., A.S.D., B.C.); the British Heart Foundation Cardiovascular Research Centre (J.J.V.M., P.S.J.) and the Robertson Centre for Biostatistics and Clinical Trials, Institute of Health and Well-b
  • Redfield MM; From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (S.D.S., M.A.P., A.S.D., B.C.); the British Heart Foundation Cardiovascular Research Centre (J.J.V.M., P.S.J.) and the Robertson Centre for Biostatistics and Clinical Trials, Institute of Health and Well-b
  • Rouleau JL; From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (S.D.S., M.A.P., A.S.D., B.C.); the British Heart Foundation Cardiovascular Research Centre (J.J.V.M., P.S.J.) and the Robertson Centre for Biostatistics and Clinical Trials, Institute of Health and Well-b
  • van Veldhuisen DJ; From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (S.D.S., M.A.P., A.S.D., B.C.); the British Heart Foundation Cardiovascular Research Centre (J.J.V.M., P.S.J.) and the Robertson Centre for Biostatistics and Clinical Trials, Institute of Health and Well-b
  • Zannad F; From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (S.D.S., M.A.P., A.S.D., B.C.); the British Heart Foundation Cardiovascular Research Centre (J.J.V.M., P.S.J.) and the Robertson Centre for Biostatistics and Clinical Trials, Institute of Health and Well-b
  • Zile MR; From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (S.D.S., M.A.P., A.S.D., B.C.); the British Heart Foundation Cardiovascular Research Centre (J.J.V.M., P.S.J.) and the Robertson Centre for Biostatistics and Clinical Trials, Institute of Health and Well-b
  • Desai AS; From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (S.D.S., M.A.P., A.S.D., B.C.); the British Heart Foundation Cardiovascular Research Centre (J.J.V.M., P.S.J.) and the Robertson Centre for Biostatistics and Clinical Trials, Institute of Health and Well-b
  • Claggett B; From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (S.D.S., M.A.P., A.S.D., B.C.); the British Heart Foundation Cardiovascular Research Centre (J.J.V.M., P.S.J.) and the Robertson Centre for Biostatistics and Clinical Trials, Institute of Health and Well-b
  • Jhund PS; From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (S.D.S., M.A.P., A.S.D., B.C.); the British Heart Foundation Cardiovascular Research Centre (J.J.V.M., P.S.J.) and the Robertson Centre for Biostatistics and Clinical Trials, Institute of Health and Well-b
  • Boytsov SA; From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (S.D.S., M.A.P., A.S.D., B.C.); the British Heart Foundation Cardiovascular Research Centre (J.J.V.M., P.S.J.) and the Robertson Centre for Biostatistics and Clinical Trials, Institute of Health and Well-b
  • Comin-Colet J; From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (S.D.S., M.A.P., A.S.D., B.C.); the British Heart Foundation Cardiovascular Research Centre (J.J.V.M., P.S.J.) and the Robertson Centre for Biostatistics and Clinical Trials, Institute of Health and Well-b
  • Cleland J; From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (S.D.S., M.A.P., A.S.D., B.C.); the British Heart Foundation Cardiovascular Research Centre (J.J.V.M., P.S.J.) and the Robertson Centre for Biostatistics and Clinical Trials, Institute of Health and Well-b
  • Düngen HD; From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (S.D.S., M.A.P., A.S.D., B.C.); the British Heart Foundation Cardiovascular Research Centre (J.J.V.M., P.S.J.) and the Robertson Centre for Biostatistics and Clinical Trials, Institute of Health and Well-b
  • Goncalvesova E; From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (S.D.S., M.A.P., A.S.D., B.C.); the British Heart Foundation Cardiovascular Research Centre (J.J.V.M., P.S.J.) and the Robertson Centre for Biostatistics and Clinical Trials, Institute of Health and Well-b
  • Katova T; From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (S.D.S., M.A.P., A.S.D., B.C.); the British Heart Foundation Cardiovascular Research Centre (J.J.V.M., P.S.J.) and the Robertson Centre for Biostatistics and Clinical Trials, Institute of Health and Well-b
  • Kerr Saraiva JF; From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (S.D.S., M.A.P., A.S.D., B.C.); the British Heart Foundation Cardiovascular Research Centre (J.J.V.M., P.S.J.) and the Robertson Centre for Biostatistics and Clinical Trials, Institute of Health and Well-b
  • Lelonek M; From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (S.D.S., M.A.P., A.S.D., B.C.); the British Heart Foundation Cardiovascular Research Centre (J.J.V.M., P.S.J.) and the Robertson Centre for Biostatistics and Clinical Trials, Institute of Health and Well-b
  • Merkely B; From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (S.D.S., M.A.P., A.S.D., B.C.); the British Heart Foundation Cardiovascular Research Centre (J.J.V.M., P.S.J.) and the Robertson Centre for Biostatistics and Clinical Trials, Institute of Health and Well-b
  • Senni M; From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (S.D.S., M.A.P., A.S.D., B.C.); the British Heart Foundation Cardiovascular Research Centre (J.J.V.M., P.S.J.) and the Robertson Centre for Biostatistics and Clinical Trials, Institute of Health and Well-b
  • Shah SJ; From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (S.D.S., M.A.P., A.S.D., B.C.); the British Heart Foundation Cardiovascular Research Centre (J.J.V.M., P.S.J.) and the Robertson Centre for Biostatistics and Clinical Trials, Institute of Health and Well-b
  • Zhou J; From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (S.D.S., M.A.P., A.S.D., B.C.); the British Heart Foundation Cardiovascular Research Centre (J.J.V.M., P.S.J.) and the Robertson Centre for Biostatistics and Clinical Trials, Institute of Health and Well-b
  • Rizkala AR; From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (S.D.S., M.A.P., A.S.D., B.C.); the British Heart Foundation Cardiovascular Research Centre (J.J.V.M., P.S.J.) and the Robertson Centre for Biostatistics and Clinical Trials, Institute of Health and Well-b
  • Gong J; From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (S.D.S., M.A.P., A.S.D., B.C.); the British Heart Foundation Cardiovascular Research Centre (J.J.V.M., P.S.J.) and the Robertson Centre for Biostatistics and Clinical Trials, Institute of Health and Well-b
  • Shi VC; From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (S.D.S., M.A.P., A.S.D., B.C.); the British Heart Foundation Cardiovascular Research Centre (J.J.V.M., P.S.J.) and the Robertson Centre for Biostatistics and Clinical Trials, Institute of Health and Well-b
  • Lefkowitz MP; From the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston (S.D.S., M.A.P., A.S.D., B.C.); the British Heart Foundation Cardiovascular Research Centre (J.J.V.M., P.S.J.) and the Robertson Centre for Biostatistics and Clinical Trials, Institute of Health and Well-b
N Engl J Med ; 381(17): 1609-1620, 2019 10 24.
Article in En | MEDLINE | ID: mdl-31475794
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.).
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Tetrazoles / Cardiovascular Diseases / Neprilysin / Angiotensin Receptor Antagonists / Valsartan / Aminobutyrates / Heart Failure / Hospitalization Type of study: Clinical_trials / Observational_studies / Prognostic_studies / Risk_factors_studies Limits: Aged / Female / Humans / Male / Middle aged Language: En Journal: N Engl J Med Year: 2019 Type: Article
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Tetrazoles / Cardiovascular Diseases / Neprilysin / Angiotensin Receptor Antagonists / Valsartan / Aminobutyrates / Heart Failure / Hospitalization Type of study: Clinical_trials / Observational_studies / Prognostic_studies / Risk_factors_studies Limits: Aged / Female / Humans / Male / Middle aged Language: En Journal: N Engl J Med Year: 2019 Type: Article