@article{15be9efec308490f982b2855853aead0,
title = "Liraglutide and cardiovascular outcomes in adults with overweight or obesity: A post hoc analysis from SCALE randomized controlled trials",
abstract = "The cardiovascular safety of liraglutide, a glucagon-like peptide-1 receptor agonist approved for weight management at a dose of 3.0 mg, was evaluated post hoc using data from 5908 participants in 5 randomized, double-blind, placebo-controlled clinical trials. Participants were randomized to liraglutide or a comparator group (placebo or orlistat). The objective was to evaluate whether cardiovascular risk was increased with liraglutide treatment. The primary composite outcome of this time-to-event analysis was the first occurrence of cardiovascular death, nonfatal myocardial infarction or nonfatal stroke. These cardiovascular events were adjudicated prospectively for three of the trials and retrospectively for two trials by an event adjudication committee. The primary outcome was analyzed using a Cox proportional hazards model, stratified by trial. With liraglutide 3.0 mg, 8 participants had positively adjudicated cardiovascular events (1.54 events/1000 person-years) compared to 10 participants in the comparators group (3.65 events/1000 person-years). The hazard ratio for liraglutide 3.0 mg compared to comparators was 0.42 (95% confidence interval, 0.17-1.08). In this analysis, liraglutide 3.0 mg treatment was not associated with excess cardiovascular risk. However, the wide confidence intervals and retrospective adjudication of events in two of the trials are limitations of the analysis.",
keywords = "GLP-1, GLP-1 analogue, antiobesity drug, cardiovascular disease, clinical trial, liraglutide",
author = "Davies, {M. J.} and Aronne, {L. J.} and Caterson, {I. D.} and Thomsen, {A. B.} and Jacobsen, {P. B.} and Marso, {S. P.}",
note = "Funding Information: We gratefully acknowledge the contribution of all trial participants and the clinical trial site personnel who assisted with the trials. We also thank Angela Stocks, PhD (Larix A/S, Copenhagen, Denmark) for editorial and medical writing services funded by Novo Nordisk. M. D. has acted as consultant, advisory board member and speaker for Novo Nordisk, Sanofi-Aventis, Lilly, Merck Sharp & Dohme, Boehringer Ingelheim, AstraZeneca and Janssen, as an advisory board member for Servier, and as a speaker for Mitsubishi Tanabe Pharma Corporation and Takeda Pharmaceuticals International Inc. and has received grants in support of investigator and investigator-initiated trials from Novo Nordisk, Sanofi-Aventis, Lilly, Boehringer Ingelheim and Janssen. L. A. is an advisor or consultant for Novo Nordisk, Eisai, GI Dynamics, Pfizer, Zafgen, ERx and Gelesis; he is an investigator for Aspire and AstraZeneca and he is a shareholder in BMIQ, Myos Corp, Jamieson Labs, Zafgen, Gelesis and ERx. I. C. has performed and still performs clinical trials of obesity treatment and prevention, some of which have been funded by government, but others by the pharmaceutical industry (current trials are funded by the NHMRC [3 trials], Novo Nordisk, Pfizer, BMS and SFI); he has given talks for Novo Nordisk, Servier Laboratories, Ache and Pfizer in the last 3 years and he is president of the World Obesity Federation. A. T. and P. J. are employees of Novo Nordisk and own stock in the company. S. M. reports receiving personal fees from Abbott Vascular and Boston Scientific related to physician education and fees from Novo Nordisk, Sanofi Aventis and Abiomed related to consulting or research activities. Novo Nordisk was responsible for the overall trial designs, and provided a formal review of the manuscript, but the authors had final authority, including choice of journal and the decision to submit the work for publication. All authors had full access to the data included in this analysis, analysed and interpreted the data, critically reviewed the manuscript and approved the final version for submission. All authors also agreed to be accountable for all aspects of the work. All authors had full access to the data included in this analysis, analysed and interpreted the data, critically reviewed the manuscript and approved the final version for submission. All authors also agreed to be accountable for all aspects of the work. Novo Nordisk was responsible for the overall trial designs, and provided a formal review of the manuscript, but the authors had final authority, including choice of journal and the decision to submit the work for publication. Funding Information: We gratefully acknowledge the contribution of all trial participants and the clinical trial site personnel who assisted with the trials. We also thank Angela Stocks, PhD (Larix A/S, Copenhagen, Denmark) for editorial and medical writing services funded by Novo Nordisk. Publisher Copyright: {\textcopyright} 2017 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.",
year = "2018",
month = mar,
doi = "10.1111/dom.13125",
language = "English (US)",
volume = "20",
pages = "734--739",
journal = "Diabetes, Obesity and Metabolism",
issn = "1462-8902",
publisher = "Wiley-Blackwell",
number = "3",
}