Compared to placebo, once-weekly Bydureon (exenatide extended-release; AstraZeneca) was not associated with an increased risk of major adverse cardiovascular events (MACE) when used as an add-on therapy to usual type 2 diabetes (T2D) care.
The ‘EXSCEL’ Phase IIIb/IV trial included over 14,000 T2D patients who were randomized to receive exenatide 2mg once-weekly or a placebo, by subcutaneous injection. The trial was conducted in order to show that Bydureon does not increase the risk of cardiovascular events, something that the Food and Drug Administration requires for T2D treatments.
Outcomes showed fewer CV events in the Bydureon group than in the placebo group, although this lower number of events did not reach statistical significance.
“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,” said Elisabeth Björk, Vice President, Head of Cardiovascular and Metabolic Diseases, AstraZeneca.
The complete results from the EXSCEL study will be presented at the European Association for the Study of Diabetes annual meeting on September 14, in Lisbon, Portugal.
Bydureon is approved for use in T2D patients as an adjunct to diet and exercise in order to improve glycemic control; it is not approved for first-line of therapy.
For more information visit Astrazeneca-us.com.