Liraglutide and cardiovascular outcomes in type 2 diabetes

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, Lucilla Monti, Piermarco Piatti

Research output: Contribution to journalArticle

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
Original languageEnglish
Pages (from-to)311 - 322
Number of pages12
JournalNew England Journal of Medicine
Volume375
Issue number4
DOIs
Publication statusPublished - Jul 28 2016

ASJC Scopus subject areas

  • Medicine(all)

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    Marso, S. P., Daniels, G. H., Frandsen, K. B., Kristensen, P., Mann, J. F. E., Nauck, M. A., Nissen, S. E., Pocock, S., Poulter, N. R., Ravn, L. S., Steinberg, W. M., Stockner, M., Zinman, B., Bergenstal, R. M., Buse, J. B., Monti, L., & Piatti, P. (2016). Liraglutide and cardiovascular outcomes in type 2 diabetes. New England Journal of Medicine, 375(4), 311 - 322. https://doi.org/10.1056/NEJMoa1603827