Cardiovascular safety of exenatide BID: an integrated analysis from controlled clinical trials in participants with type 2 diabetesReport as inadecuate




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Cardiovascular Diabetology

, 10:22

First Online: 16 March 2011Received: 05 November 2010Accepted: 16 March 2011

Abstract

It is important for patients that treatments for diabetes not increase cardiovascular CV risk. The objective of this analysis was to examine retrospectively the CV safety of exenatide BID, a GLP-1 receptor agonist approved for treating hyperglycemia in patients with type 2 diabetes not adequately controlled with diet and exercise. Individual participant data was pooled to assess the relative risk RR of CV events with exenatide BID versus a pooled comparator PC group treated with either placebo or insulin from 12 controlled, randomized, clinical trials ranging from 12-52 weeks. Mean baseline values for HbA1c 8.33-8.38%, BMI 31.3-31.5 kg-m, and duration of diabetes 8 y were similar between groups. Trials included patients with histories of microvascular and-or macrovascular disease. Customized primary major adverse CV events MACE included stroke, myocardial infarction, cardiac mortality, acute coronary syndrome, and revascularization procedures. The Primary MACE RR 0.7; 95% CI 0.38, 1.31, calculated by the Mantel-Haenszel method stratified by study, suggested that exenatide use vs. PC did not increase CV risk; this result was consistent across multiple analytic methods. Because the trials were not designed to assess CV outcomes, events were identified retrospectively from a list of preferred terms by physicians blinded to treatment. Other limitations included the low number of CV events, the short duration of trials ≤1 y, and a single active comparator insulin. The results of these analyses are consistent with those of a recent retrospective analysis of a large insurance database that found that patients treated with exenatide twice daily were less likely to have a CV event than were patients treated with other glucose-lowering therapies.

Keywords : GLP-1 receptor agonist, diabetes, cardiovascular safety

KeywordsGLP-1 receptor agonist diabetes cardiovascular safety Electronic supplementary materialThe online version of this article doi:10.1186-1475-2840-10-22 contains supplementary material, which is available to authorized users.

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Author: Robert Ratner - Jenny Han - Dawn Nicewarner - Irina Yushmanova - Byron J Hoogwerf - Larry Shen

Source: https://link.springer.com/article/10.1186/1475-2840-10-22







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