Semaglutide and Cardiovascular Outcomes in Obesity without Diabetes.

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 Dec 2023

Historique:

pubmed: 12 11 2023

medline: 12 11 2023

entrez: 12 11 2023

Statut: ppublish

Résumé

Semaglutide, a glucagon-like peptide-1 receptor agonist, has been shown to reduce the risk of adverse cardiovascular events in patients with diabetes. Whether semaglutide can reduce cardiovascular risk associated with overweight and obesity in the absence of diabetes is unknown. In a multicenter, double-blind, randomized, placebo-controlled, event-driven superiority trial, we enrolled patients 45 years of age or older who had preexisting cardiovascular disease and a body-mass index (the weight in kilograms divided by the square of the height in meters) of 27 or greater but no history of diabetes. Patients were randomly assigned in a 1:1 ratio to receive once-weekly subcutaneous semaglutide at a dose of 2.4 mg or placebo. The primary cardiovascular end point was a composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke in a time-to-first-event analysis. Safety was also assessed. A total of 17,604 patients were enrolled; 8803 were assigned to receive semaglutide and 8801 to receive placebo. The mean (±SD) duration of exposure to semaglutide or placebo was 34.2±13.7 months, and the mean duration of follow-up was 39.8±9.4 months. A primary cardiovascular end-point event occurred in 569 of the 8803 patients (6.5%) in the semaglutide group and in 701 of the 8801 patients (8.0%) in the placebo group (hazard ratio, 0.80; 95% confidence interval, 0.72 to 0.90; P<0.001). Adverse events leading to permanent discontinuation of the trial product occurred in 1461 patients (16.6%) in the semaglutide group and 718 patients (8.2%) in the placebo group (P<0.001). In patients with preexisting cardiovascular disease and overweight or obesity but without diabetes, weekly subcutaneous semaglutide at a dose of 2.4 mg was superior to placebo in reducing the incidence of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke at a mean follow-up of 39.8 months. (Funded by Novo Nordisk; SELECT ClinicalTrials.gov number, NCT03574597.).

Sections du résumé

BACKGROUND BACKGROUND

METHODS METHODS

In a multicenter, double-blind, randomized, placebo-controlled, event-driven superiority trial, we enrolled patients 45 years of age or older who had preexisting cardiovascular disease and a body-mass index (the weight in kilograms divided by the square of the height in meters) of 27 or greater but no history of diabetes. Patients were randomly assigned in a 1:1 ratio to receive once-weekly subcutaneous semaglutide at a dose of 2.4 mg or placebo. The primary cardiovascular end point was a composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke in a time-to-first-event analysis. Safety was also assessed.

RESULTS RESULTS

A total of 17,604 patients were enrolled; 8803 were assigned to receive semaglutide and 8801 to receive placebo. The mean (±SD) duration of exposure to semaglutide or placebo was 34.2±13.7 months, and the mean duration of follow-up was 39.8±9.4 months. A primary cardiovascular end-point event occurred in 569 of the 8803 patients (6.5%) in the semaglutide group and in 701 of the 8801 patients (8.0%) in the placebo group (hazard ratio, 0.80; 95% confidence interval, 0.72 to 0.90; P<0.001). Adverse events leading to permanent discontinuation of the trial product occurred in 1461 patients (16.6%) in the semaglutide group and 718 patients (8.2%) in the placebo group (P<0.001).

CONCLUSIONS CONCLUSIONS

In patients with preexisting cardiovascular disease and overweight or obesity but without diabetes, weekly subcutaneous semaglutide at a dose of 2.4 mg was superior to placebo in reducing the incidence of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke at a mean follow-up of 39.8 months. (Funded by Novo Nordisk; SELECT ClinicalTrials.gov number, NCT03574597.).

Identifiants

DOI: 10.1056/NEJMoa2307563 PMID: 37952131

pubmed: 37952131

doi: 10.1056/NEJMoa2307563

doi:

Banques de données

ClinicalTrials.gov

['NCT03574597']

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

Pagination

2221-2232

Investigateurs

A Porto (A)

A Villarino (A)

C Chacon (C)

C J Zaidman (CJ)

E Farias (E)

E Duronto (E)

J M Farias (JM)

M Casas (M)

A Oviedo (A)

H D Sanabria (HD)

P Perez Terns (P)

J Amerena (J)

M Leung (M)

D M Colquhoun (DM)

P Purnell (P)

M William (M)

W P Abhayaratna (WP)

C Morbey (C)

S Nicholls (S)

D Cross (D)

M Arstall (M)

K Kostner (K)

M Shirazi (M)

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H Toplak (H)

U Hanusch (U)

E Aigner (E)

B Ludvik (B)

A Kautzky-Willer (A)

R Prager (R)

S Kaser (S)

P Vanduynhoven (P)

J Verwerft (J)

M Vrolix (M)

M De Pauw (M)

C Vercammen (C)

P Van De Borne (P)

Z R Prakova-Teneva (ZR)

N Runev (N)

I Petrov (I)

M Milanova (M)

A Postadzhiyan (A)

V Gelev (V)

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B Georgiev (B)

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