Cardiovascular and Renal Outcomes with Empagliflozin in Heart Failure.

Aged Benzhydryl Compounds / adverse effects Cardiovascular Diseases / mortality Diabetes Mellitus, Type 2 / complications Disease Progression Double-Blind Method Female Glomerular Filtration Rate / drug effects Glucosides / adverse effects Heart Failure / complications Hospitalization / statistics & numerical data Humans Male Middle Aged Proportional Hazards Models Renal Insufficiency, Chronic / complications Sodium-Glucose Transporter 2 Inhibitors / adverse effects 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:
08 10 2020

Historique:

pubmed: 1 9 2020

medline: 22 10 2020

entrez: 1 9 2020

Statut: ppublish

Résumé

Sodium-glucose cotransporter 2 (SGLT2) inhibitors reduce the risk of hospitalization for heart failure in patients regardless of the presence or absence of diabetes. More evidence is needed regarding the effects of these drugs in patients across the broad spectrum of heart failure, including those with a markedly reduced ejection fraction. In this double-blind trial, we randomly assigned 3730 patients with class II, III, or IV heart failure and an ejection fraction of 40% or less to receive empagliflozin (10 mg once daily) or placebo, in addition to recommended therapy. The primary outcome was a composite of cardiovascular death or hospitalization for worsening heart failure. During a median of 16 months, a primary outcome event occurred in 361 of 1863 patients (19.4%) in the empagliflozin group and in 462 of 1867 patients (24.7%) in the placebo group (hazard ratio for cardiovascular death or hospitalization for heart failure, 0.75; 95% confidence interval [CI], 0.65 to 0.86; P<0.001). The effect of empagliflozin on the primary outcome was consistent in patients regardless of the presence or absence of diabetes. The total number of hospitalizations for heart failure was lower in the empagliflozin group than in the placebo group (hazard ratio, 0.70; 95% CI, 0.58 to 0.85; P<0.001). The annual rate of decline in the estimated glomerular filtration rate was slower in the empagliflozin group than in the placebo group (-0.55 vs. -2.28 ml per minute per 1.73 m Among patients receiving recommended therapy for heart failure, those in the empagliflozin group had a lower risk of cardiovascular death or hospitalization for heart failure than those in the placebo group, regardless of the presence or absence of diabetes. (Funded by Boehringer Ingelheim and Eli Lilly; EMPEROR-Reduced ClinicalTrials.gov number, NCT03057977.).

Sections du résumé

BACKGROUND

METHODS

In this double-blind trial, we randomly assigned 3730 patients with class II, III, or IV heart failure and an ejection fraction of 40% or less to receive empagliflozin (10 mg once daily) or placebo, in addition to recommended therapy. The primary outcome was a composite of cardiovascular death or hospitalization for worsening heart failure.

RESULTS

During a median of 16 months, a primary outcome event occurred in 361 of 1863 patients (19.4%) in the empagliflozin group and in 462 of 1867 patients (24.7%) in the placebo group (hazard ratio for cardiovascular death or hospitalization for heart failure, 0.75; 95% confidence interval [CI], 0.65 to 0.86; P<0.001). The effect of empagliflozin on the primary outcome was consistent in patients regardless of the presence or absence of diabetes. The total number of hospitalizations for heart failure was lower in the empagliflozin group than in the placebo group (hazard ratio, 0.70; 95% CI, 0.58 to 0.85; P<0.001). The annual rate of decline in the estimated glomerular filtration rate was slower in the empagliflozin group than in the placebo group (-0.55 vs. -2.28 ml per minute per 1.73 m

CONCLUSIONS

Among patients receiving recommended therapy for heart failure, those in the empagliflozin group had a lower risk of cardiovascular death or hospitalization for heart failure than those in the placebo group, regardless of the presence or absence of diabetes. (Funded by Boehringer Ingelheim and Eli Lilly; EMPEROR-Reduced ClinicalTrials.gov number, NCT03057977.).

Identifiants

DOI: 10.1056/NEJMoa2022190 PMID: 32865377

pubmed: 32865377

doi: 10.1056/NEJMoa2022190

doi:

Substances chimiques

Benzhydryl Compounds 0

Glucosides 0

Sodium-Glucose Transporter 2 Inhibitors 0

empagliflozin HDC1R2M35U

Banques de données

ClinicalTrials.gov

['NCT03057977']

Types de publication

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

Langues

eng

Sous-ensembles de citation

Pagination

1413-1424

Investigateurs

D Aizenberg (D)

L Cartasegna (L)

H Colombo (H)

M Fernandez Moutin (M)

J Glenny (J)

C Alvarez Lorio (C)

D Anauch (D)

R Campos (R)

A Facta (A)

A Fernandez (A)

R Ahuad Guerrero (R)

L Lobo Márquez (L)

R A Leon de la Fuente (RA)

M Mansilla (M)

M Hominal (M)

E Hasbani (E)

M Najenson (M)

H Luquez (H)

L Guzman (L)

H Sessa (H)

M Amuchástegui (M)

O Salomone (O)

E Perna (E)

D Piskorz (D)

M Sicer (M)

D Perez de Arenaza (D)

C Zaidman (C)

S Nani (S)

C Poy (C)

J Resk (J)

R Villarreal (R)

C Majul (C)

F Colombo Berra (F)

T Smith Casabella (T)

G Carnero (G)

A Caccavo (A)

M Berli (M)

N Budassi (N)

J Bono (J)

A Alvarisqueta (A)

J Amerena (J)

K Kostner (K)

A Hamilton (A)

A Begg (A)

D Colquhoun (D)

A Sverdlov (A)

G Vaddadi (G)

J Wong (J)

J Coller (J)

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