Empagliflozin in Heart Failure with a Preserved Ejection Fraction.

Adult Benzhydryl Compounds / administration & dosage Cardiovascular Diseases / mortality Chronic Disease Double-Blind Method Female Glucosides / administration & dosage Heart Failure / drug therapy Hospitalization / statistics & numerical data Humans Male Sodium-Glucose Transporter 2 Inhibitors / administration & dosage Stroke Volume

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:
14 10 2021

Historique:

pubmed: 28 8 2021

medline: 29 10 2021

entrez: 27 8 2021

Statut: ppublish

Résumé

Sodium-glucose cotransporter 2 inhibitors reduce the risk of hospitalization for heart failure in patients with heart failure and a reduced ejection fraction, but their effects in patients with heart failure and a preserved ejection fraction are uncertain. In this double-blind trial, we randomly assigned 5988 patients with class II-IV heart failure and an ejection fraction of more than 40% to receive empagliflozin (10 mg once daily) or placebo, in addition to usual therapy. The primary outcome was a composite of cardiovascular death or hospitalization for heart failure. Over a median of 26.2 months, a primary outcome event occurred in 415 of 2997 patients (13.8%) in the empagliflozin group and in 511 of 2991 patients (17.1%) in the placebo group (hazard ratio, 0.79; 95% confidence interval [CI], 0.69 to 0.90; P<0.001). This effect was mainly related to a lower risk of hospitalization for heart failure in the empagliflozin group. The effects of empagliflozin appeared consistent in patients with or without diabetes. The total number of hospitalizations for heart failure was lower in the empagliflozin group than in the placebo group (407 with empagliflozin and 541 with placebo; hazard ratio, 0.73; 95% CI, 0.61 to 0.88; P<0.001). Uncomplicated genital and urinary tract infections and hypotension were reported more frequently with empagliflozin. Empagliflozin reduced the combined risk of cardiovascular death or hospitalization for heart failure in patients with heart failure and a preserved ejection fraction, regardless of the presence or absence of diabetes. (Funded by Boehringer Ingelheim and Eli Lilly; EMPEROR-Preserved ClinicalTrials.gov number, NCT03057951).

Sections du résumé

BACKGROUND

METHODS

In this double-blind trial, we randomly assigned 5988 patients with class II-IV heart failure and an ejection fraction of more than 40% to receive empagliflozin (10 mg once daily) or placebo, in addition to usual therapy. The primary outcome was a composite of cardiovascular death or hospitalization for heart failure.

RESULTS

Over a median of 26.2 months, a primary outcome event occurred in 415 of 2997 patients (13.8%) in the empagliflozin group and in 511 of 2991 patients (17.1%) in the placebo group (hazard ratio, 0.79; 95% confidence interval [CI], 0.69 to 0.90; P<0.001). This effect was mainly related to a lower risk of hospitalization for heart failure in the empagliflozin group. The effects of empagliflozin appeared consistent in patients with or without diabetes. The total number of hospitalizations for heart failure was lower in the empagliflozin group than in the placebo group (407 with empagliflozin and 541 with placebo; hazard ratio, 0.73; 95% CI, 0.61 to 0.88; P<0.001). Uncomplicated genital and urinary tract infections and hypotension were reported more frequently with empagliflozin.

CONCLUSIONS

Empagliflozin reduced the combined risk of cardiovascular death or hospitalization for heart failure in patients with heart failure and a preserved ejection fraction, regardless of the presence or absence of diabetes. (Funded by Boehringer Ingelheim and Eli Lilly; EMPEROR-Preserved ClinicalTrials.gov number, NCT03057951).

Identifiants

DOI: 10.1056/NEJMoa2107038 PMID: 34449189

pubmed: 34449189

doi: 10.1056/NEJMoa2107038

doi:

Substances chimiques

Benzhydryl Compounds 0

Glucosides 0

Sodium-Glucose Transporter 2 Inhibitors 0

empagliflozin HDC1R2M35U

Banques de données

ClinicalTrials.gov

['NCT03057951']

Types de publication

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

Langues

eng

Sous-ensembles de citation

Pagination

1451-1461

Investigateurs

D Aizenberg (D)

L Cartasegna (L)

H Colombo (H)

J Fernandez Mouti (J)

M Koretzky (M)

J Archibaldo Glenny (J)

C A Alvarez Iorio (CA)

D J Anauch (DJ)

R Henquin (R)

V E Cavenago (VE)

R C Campos (RC)

A Facta (A)

A Fernandez (A)

R A Ahuad Guerrero (RA)

L Lobo Márquez (L)

R A Leon de la Fuente (RA)

M V Mansilla (MV)

M A Hominal (MA)

E Hasbani (E)

M Najenson (M)

H A Luquez (HA)

L A Guzman (LA)

H A Sessa (HA)

O A Salomone (OA)

E Perna (E)

D Piskorz (D)

M Sicer (M)

D Perez de Arenaza (D)

C J Zaidman (CJ)

S Nani (S)

J Resk (J)

R A Villarreal (RA)

C R Majul (CR)

F Colombo Berra (F)

T Smith Casabella (T)

S A Sassone (SA)

G Carnero (G)

A Caccavo (A)

M A Berli (MA)

N Budassi (N)

J Bono (J)

A Alvarisqueta (A)

D Colquhoun (D)

J Amerena (J)

J Beltrame (J)

A Sverdlov (A)

G Vaddadi (G)

A Hamilton (A)

M Stokes (M)

S Nicholls (S)

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