Large outcomes trial confirms CV safety of GLP-1 analogue in T2DM at wide range of CV risk

EASD 2017 -Lisbon, Portugal

News - Sep. 18, 2017

Presented at the European Association for the Study of Diabetes (EASD) Annual Meeting in Lisbon, Portugal (11-15 September)

Results from the EXSCEL (EXenatide Study of Cardiovascular Event Lowering) trial showed CV safety with exenatide extended-release in patients with type 2 diabetes (T2DM) at a wide range of CV risk.

Exenatide once-weekly did not increase the incidence of major adverse cardiovascular events (MACE), a composite endpoint of CV death, non-fatal heart attack (myocardial infarction) or non-fatal stroke, compared to placebo (HR: 0.91; 95%CI: 0.83-1.00; p<0.001 for non-inferiority).

There were also fewer CV events observed in the exenatide arm of the trial (839 [11.4%] vs. 905 [12.2%]), although the primary efficacy objective of a superior reduction in MACE narrowly missed statistical significance (p=0.061). The direction of the CV outcomes results in EXSCEL was consistent with those seen in recently completed outcomes trials within the GLP-1 receptor agonist class. Additionally, in a prespecified secondary analysis, patients on exenatide had a 14% lower incidence of death from all causes (HR: 0.86; 95% CI: 0.77-0.97).

Multiple sensitivity analyses for MACE, recalculating the outcome under alternative assumptions to determine the potential impact of different variables, were consistent with primary analyses. No safety issues were identified during the EXSCEL trial and data were consistent with the known safety profile of exenatide. Specifically, there was no imbalance in retinopathy.

The EXSCEL trial enrolled the largest and most inclusive patient population of any CV outcomes trial of the glucagon-like peptide-1 (GLP-1) receptor agonist class conducted to date, having included more than 14,500 patients at 687 trial sites across 35 countries, incorporating usual care and wide-ranging eligibility criteria.

Exenatide is indicated as an adjunct to diet and exercise to improve glycemic control in adults with T2DM. Exenatide is not indicated to reduce the risk of MACE or all-cause mortality, and there are no clinical trials establishing conclusive evidence of macrovascular risk reduction with exenatide.

Source: Press release 14 September 2017Results of the EXSCEL trial were simultaneously published at N Eng J Med

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