AstraZeneca's Bydureon falls short in heart study
- AstraZeneca plc on Thursday announced the results from the 14,000-patient EXSCEL cardiovascular outcomes study at the European Association for the Study of Diabetes (EASD) annual meeting.
- Results showed the once-weekly glucagon-like peptide-1 (GLP-1) agonist Bydureon did not increase the risk of a major adverse cardiovascular event (MACE), such as heart attack, stroke or death.
- While there were numerically fewer cardiovascular events in the Bydureon arm of the type 2 diabetes trial, the drug did not show statistical superiority in reducing the likelihood of MACE when compared with a placebo.
Bydureon (exenatide extended-release) is a relatively older drug in a crowded marketplace that now has several other approved GLP-1s. Bydureon and its predecessor Byetta were some of the first drugs in the class more than a decade ago.
Had the study shown an ability to help prevent cardiovascular events, AstraZeneca may have seen a resurgence in sales of the once-weekly treatment.
Cardiovascular outcomes trials take a long time to conduct due to the large number of patients required to participate and their event-driven nature. Recently, though, a number of these big trials have read out, with implications for the market's competitive landscape.
Currently, none of the three dipeptidyl peptidase 4 (DPP-4) inhibitors have shown a cardio-protective benefit in outcomes trials, including Merck & Co.’s blockbuster Januvia (sitagliptin).
Meanwhile, two of the sodium glucose transporter-2 (SGLT-2s) inhibitors — Eli Lilly & Co.’s Jardiance (empagliflozin) and Johnson & Johnson’s Invokana (canagliflozin) — have shown the ability to lower the risk of cardiovascular death. This resulted in an updated label for Jardiance that has Lilly seeking increased market share for the drug.
A lack of cardio-protective benefits and injectable administration could mean GLP-1s become less frequently used than oral SGLT2s or pushed further back in the continuum of treatment.
- The New England Journal of Medicine Effects of once-weekly exenatide on cardiovascular outcomes in type 2 diabetes
- AstraZeneca Press release
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