AstraZeneca has announced new clinical data that offers evidence of the strong cardiovascular safety profile of its type 2 diabetes therapy Bydureon.
The phase IIIb/IV EXSCEL trial was conducted to compare the effect of once-weekly Bydureon versus placebo, when added to usual type 2 diabetes care, on the risk of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke.
“AstraZeneca has reported clinical trial data that demonstrates the cardiovascular safety profile of Bydureon.“
Bydureon met its primary safety objective of noninferiority. Indeed, fewer cardiovascular events were observed in the Bydureon arm of the trial, although this trend did not reach statistical significance.
The EXSCEL trial is the largest and most inclusive patient population of any cardiovascular outcomes trial of the glucagon-like peptide-1 receptor agonist therapy class, with more than 14,000 patients from 35 countries included.
Elisabeth Bjork, vice-president and head of cardiovascular and metabolic disease within AstraZeneca's global medicines development business, said: "These top-line results from the EXSCEL trial provide robust evidence of the cardiovascular safety profile of Bydureon across a wide range of patients with type 2 diabetes."
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