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Full results of AstraZeneca's EXSCEL trial announced

Amy Schofield 05 October 2017

AstraZeneca has announced full results from the EXSCEL (EXenatide Study of Cardiovascular Event Lowering) trial, which showed cardiovascular (CV) safety with Bydureon (exenatide extended-release) in patients with type 2 diabetes (T2D) at a wide range of CV risk.

Exenatide extended-release 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.

There were also fewer CV events observed in the exenatide arm of the trial, although the primary efficacy objective of a superior reduction in MACE narrowly missed statistical significance.

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% reduction in risk of death from all causes.

The full results of EXSCEL, including important secondary endpoints, sensitivity analyses and regional data, were presented at the 53rd annual meeting of EASD and also published online in the New England Journal of Medicine.

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 extended-release.

Specifically, there was no imbalance in retinopathy, a microvascular complication that commonly occurs from T2D and can lead to serious visual disability and blindness.

Investigator Rury Holman, Professor of Diabetic Medicine and Diabetes Trials Unit Director, University of Oxford, said: “The EXSCEL study results demonstrated that exenatide could have an acceptable CV safety profile in patients with type 2 diabetes with a wide range of cardiovascular risk and suggested a potential benefit with respect to all-cause mortality.”

Lisa Anson, Country President, AstraZeneca UK, said: “EXSCEL is the largest and most inclusive GLP-1 CV outcomes trial conducted to-date, and provides robust evidence of the CV safety profile of exenatide extended-release across a wide range of patients.”

In the UK, there are around 4.5 million people living with diabetes, with a further 1.1 million estimated to be living with the condition undiagnosed.

 

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