Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes.
- From the University of Texas Southwestern Medical Center, Dallas (S.P.M.)
- Massachusetts General Hospital, Boston (G.H.D.)
- Novo Nordisk, Bagsvaerd, Denmark (K.B.-F., P.K., L.S.R., M.S.)
- Friedrich Alexander University of Erlangen, Erlangen (J.F.E.M.), and St. Josef Hospital, Ruhr University, Bochum (M.A.N.) - both in Germany
- Cleveland Clinic, Cleveland (S.E.N.)
- London School of Hygiene and Tropical Medicine Medical Statistics Unit (S.P.) and Imperial College London (N.R.P.), London
- George Washington University Medical Center, Washington, DC (W.M.S.)
- Lunenfeld-Tanenbaum Research Institute, Mt. Sinai Hospital, University of Toronto, Toronto (B.Z.)
- International Diabetes Center at Park Nicollet, Minneapolis (R.M.B.)
- and the University of North Carolina School of Medicine, Chapel Hill (J.B.B.).
The New England journal of medicine Vol. 375 · Issue 4 · pp. 311-22
PMID 27295427 DOI 10.1056/nejmoa1603827
Cite This Article
Steven P Marso, Gilbert H Daniels, Kirstine Brown-Frandsen, Peter Kristensen, Johannes F E Mann, Michael A Nauck, Steven E Nissen, Stuart Pocock, Neil R Poulter, Lasse S Ravn, William M Steinberg, Mette Stockner, Bernard Zinman, Richard M Bergenstal, John B Buse. Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes. The New England journal of medicine. 2016;375(4):311-22. doi:10.1056/nejmoa1603827
Abstract
BACKGROUND: The cardiovascular effect of liraglutide, a glucagon-like peptide 1 analogue, when added to standard care in patients with type 2 diabetes, remains unknown.
METHODS: In this double-blind trial, we randomly assigned patients with type 2 diabetes and high cardiovascular risk to receive liraglutide or placebo. The primary composite outcome in the time-to-event analysis was the first occurrence of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke. The primary hypothesis was that liraglutide would be noninferior to placebo with regard to the primary outcome, with a margin of 1.30 for the upper boundary of the 95% confidence interval of the hazard ratio. No adjustments for multiplicity were performed for the prespecified exploratory outcomes.
RESULTS: A total of 9340 patients underwent randomization. The median follow-up was 3.8 years. The primary outcome occurred in significantly fewer patients in the liraglutide group (608 of 4668 patients [13.0%]) than in the placebo group (694 of 4672 [14.9%]) (hazard ratio, 0.87; 95% confidence interval [CI], 0.78 to 0.97; P
CONCLUSIONS: In the time-to-event analysis, the rate of the first occurrence of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke among patients with type 2 diabetes mellitus was lower with liraglutide than with placebo. (Funded by Novo Nordisk and the National Institutes of Health; LEADER ClinicalTrials.gov number, NCT01179048.).
Keywords
- Aged
- Cardiovascular Diseases
- Diabetes Mellitus
- Type 2
- Double-Blind Method
- Female
- Gastrointestinal Diseases
- Humans
- Hypoglycemic Agents
- Liraglutide
- Male
- Middle Aged
- Myocardial Infarction
- Stroke
- Treatment Outcome




