Angiotensin-Neprilysin Inhibition in Heart Failure with Preserved Ejection Fraction.

Aged Aminobutyrates / administration & dosage Angioedema / chemically induced Angiotensin Receptor Antagonists / administration & dosage Biphenyl Compounds Cardiovascular Diseases / mortality Double-Blind Method Drug Combinations Female Follow-Up Studies Heart Failure / drug therapy Hospitalization / statistics & numerical data Humans Hypotension / chemically induced Male Middle Aged Neprilysin / antagonists & inhibitors Quality of Life Sex Factors Single-Blind Method Stroke Volume Tetrazoles / administration & dosage Valsartan / administration & dosage

Journal

The New England journal of medicine

ISSN: 1533-4406

Titre abrégé: N Engl J Med

Pays: United States

ID NLM: 0255562

Informations de publication

Date de publication:
24 10 2019

Historique:

pubmed: 3 9 2019

medline: 7 11 2019

entrez: 3 9 2019

Statut: ppublish

Résumé

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. 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. 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. 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.).

Sections du résumé

BACKGROUND

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.).

Identifiants

DOI: 10.1056/NEJMoa1908655 PMID: 31475794

pubmed: 31475794

doi: 10.1056/NEJMoa1908655

doi:

Substances chimiques

Aminobutyrates 0

Angiotensin Receptor Antagonists 0

Biphenyl Compounds 0

Drug Combinations 0

Tetrazoles 0

Valsartan 80M03YXJ7I

Neprilysin EC 3.4.24.11

sacubitril and valsartan sodium hydrate drug combination WB8FT61183

Banques de données

ClinicalTrials.gov

['NCT01920711']

Types de publication

Comparative Study Journal Article Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

Pagination

1609-1620

Investigateurs

S Perrone (S)

J Albisu (J)

H Avaca (H)

C Chacon (C)

G Cursack (G)

M Diez (M)

A Duarte (A)

A Fernandez (A)

A Gabito (A)

P Gitelman (P)

M Hominal (M)

R Leon de la Fuente (R)

J Llanos (J)

C Majul (C)

G Mercau (G)

G Moises Azize (G)

O Montana (O)

F Perez Manghi (F)

C Poy (C)

A Prado (A)

H Ramos (H)

J Resk (J)

G Scaro (G)

L Schiavi (L)

J Soler (J)

O Vogelmann (O)

L Wenetz (L)

C Zaidman (C)

N Anavekar (N)

J Amerena (J)

D Cross (D)

C De Pasquale (C)

D Eccleston (D)

L Howes (L)

M William (M)

R Zweiker (R)

C Adlbrecht (C)

J Altenberger (J)

J Auer (J)

D Bonderman (D)

P Siostrzonek (P)

W Weihs (W)

M Zaruba (M)

S Janssens (S)

D Derthoo (D)

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