Why did AstraZeneca's Bydureon fail to cut CV risks? A broad patient group, perhaps

AstraZeneca's Bydureon outcomes trial involved more than 14,500 patients.

LISBON, PortugalAstraZeneca is out with the details on an outcomes trial in which once-weekly GLP-1 Bydureon failed to post a significant cardiovascular benefit. And while it may have been close, that won't earn it a new indicationand it won't help it vie with Novo Nordisk's heart-helping GLP-1s, either.

Despite recording a 14% reduction in the risk of death from any cause and tallying 839 deaths compared with placebo’s 905, Bydureon failed to significantly decrease Type 2 diabetes patients’ combined risk of heart attack, stroke and cardiovascular death, AstraZeneca said Thursday.

The result, presented at the European Society for the Study of Diabetes (EASD) annual meeting, dented the notion that Novo Nordisk’s recent trial wins would necessarily apply more broadly to GLP-1sand left AstraZeneca on the outside looking in.

That’s not to say it wasn’t close, though. The study’s p value of 0.061 only just missed statistical significance, and the fact that the trial enrolled a wide pool of participants, featuring more than 14,500 patients of all ages and blood sugar levels, may have factored in, according to Jim McDermott, AstraZeneca’s Medical Affairs lead for diabetes.

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The miss is “unfortunate, but that’s part of clinical trial design, especially when you try to be as broad we did,” he said, noting that “to me it’s not about missing. It’s about that we did demonstrate CV safety."

“One of the things that’s really important to remember when we’re looking across these different trials is that they are all asking and answering different questions,” Sarah Walters, AZ’s commercial business leader for diabetes, added in a separate interview. “It is the broadest, most inclusive study we have seen in the GLP-1 space,” and it’s “very robust data that is, I think, incredibly relevant” to physicians’ patient populations.

The drugmaker back in May announced top-line results showing that Bydureon could match placebo in terms of CV safety, and that announcement came not long after Novo’s outcomes triumphs. Last June, Victoza showed it could pare down patients’ cardiovascular risk by 13%, and semaglutide followed up that September by demonstrating that it could slash risks by 26%. Victoza won a new indication for CV risk reduction last month.

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And they’re not alone in the Type 2 diabetes world. A pair of SGLT2 medsEli Lilly and Boehringer Ingelheim’s Jardiance and Johnson & Johnson’s Invokanahave posted positive outcomes results, too.

The way McDermott sees it, though, Bydureon’s long tenure on the GLP-1 market will work in its favor. “What we see with the history of Bydureon, the fact that it is the one with seven years of safety data ... It’s going to be up to the physicians to determine what is appropriate care for their patients, but we think Bydureon is very good,” he said.