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

doi:10.1056/NEJMoa1603827

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

IRCCS Ospedale San Raffaele

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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 language	English
Pages (from-to)	311 - 322
Number of pages	12
Journal	New England Journal of Medicine
Volume	375
Issue number	4
DOIs	https://doi.org/10.1056/NEJMoa1603827
Publication status	Published - Jul 28 2016

ASJC Scopus subject areas

Medicine(all)

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10.1056/NEJMoa1603827

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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

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

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title = "Liraglutide and cardiovascular outcomes in type 2 diabetes",

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",

author = "Marso, {Steven P.} and Daniels, {Gilbert H.} and Frandsen, {Kirstine Brown} and Peter Kristensen and Mann, {Johannes F.E.} and Nauck, {Michael A.} and Nissen, {Steven E.} and Stuart Pocock and Poulter, {Neil R.} and Ravn, {Lasse S.} and Steinberg, {William M.} and Mette Stockner and Bernard Zinman and Bergenstal, {Richard M.} and Buse, {John B.} and Lucilla Monti and Piermarco Piatti",

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T1 - Liraglutide and cardiovascular outcomes in type 2 diabetes

AU - Marso, Steven P.

AU - Daniels, Gilbert H.

AU - Frandsen, Kirstine Brown

AU - Kristensen, Peter

AU - Mann, Johannes F.E.

AU - Nauck, Michael A.

AU - Nissen, Steven E.

AU - Pocock, Stuart

AU - Poulter, Neil R.

AU - Ravn, Lasse S.

AU - Steinberg, William M.

AU - Stockner, Mette

AU - Zinman, Bernard

AU - Bergenstal, Richard M.

AU - Buse, John B.

AU - Monti, Lucilla

AU - Piatti, Piermarco

PY - 2016/7/28

Y1 - 2016/7/28

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

AB - 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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Liraglutide and cardiovascular outcomes in type 2 diabetes

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