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

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Type 2 Diabetes Mellitus
Placebos
Confidence Intervals
Glucagon-Like Peptide 1
Random Allocation
Cause of Death
Patient Care
Stroke
Myocardial Infarction
Liraglutide

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Marso, S. P., Daniels, G. H., Frandsen, K. B., Kristensen, P., Mann, J. F. E., Nauck, M. A., ... 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

Liraglutide and cardiovascular outcomes in type 2 diabetes. / Marso, Steven P.; Daniels, Gilbert H.; Frandsen, Kirstine Brown; Kristensen, Peter; Mann, Johannes F.E.; Nauck, Michael A.; Nissen, Steven E.; Pocock, Stuart; Poulter, Neil R.; Ravn, Lasse S.; Steinberg, William M.; Stockner, Mette; Zinman, Bernard; Bergenstal, Richard M.; Buse, John B.; Monti, Lucilla; Piatti, Piermarco.

In: New England Journal of Medicine, Vol. 375, No. 4, 28.07.2016, p. 311 - 322.

Research output: Contribution to journalArticle

Marso, SP, Daniels, GH, Frandsen, KB, Kristensen, P, Mann, JFE, Nauck, MA, Nissen, SE, Pocock, S, Poulter, NR, Ravn, LS, Steinberg, WM, Stockner, M, Zinman, B, Bergenstal, RM, Buse, JB, Monti, L & Piatti, P 2016, 'Liraglutide and cardiovascular outcomes in type 2 diabetes', New England Journal of Medicine, vol. 375, no. 4, pp. 311 - 322. https://doi.org/10.1056/NEJMoa1603827
Marso SP, Daniels GH, Frandsen KB, Kristensen P, Mann JFE, Nauck MA et al. Liraglutide and cardiovascular outcomes in type 2 diabetes. New England Journal of Medicine. 2016 Jul 28;375(4):311 - 322. https://doi.org/10.1056/NEJMoa1603827
Marso, Steven P. ; Daniels, Gilbert H. ; Frandsen, Kirstine Brown ; Kristensen, Peter ; Mann, Johannes F.E. ; Nauck, Michael A. ; Nissen, Steven E. ; Pocock, Stuart ; Poulter, Neil R. ; Ravn, Lasse S. ; Steinberg, William M. ; Stockner, Mette ; Zinman, Bernard ; Bergenstal, Richard M. ; Buse, John B. ; Monti, Lucilla ; Piatti, Piermarco. / Liraglutide and cardiovascular outcomes in type 2 diabetes. In: New England Journal of Medicine. 2016 ; Vol. 375, No. 4. pp. 311 - 322.
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N2 - 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

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