June 19th, 2013

Top-Line Results: No Cardiovascular Benefits Found For Saxagliptin

Top-line results of a large phase 4 study with saxagliptin (Onglyza, Bristol-Myers Squibb and AstraZeneca) demonstrate that the drug is safe but has no cardiovascular benefits. AstraZeneca and Bristol-Myers Squibb today announced the top-line results for the SAVOR-TIMI-53 Cardiovascular Outcomes Trial of Onglyza®. The full results are scheduled to presented at the annual meeting of the European Society of Cardiology in Amsterdam on September 2 by Deepak Bhatt.

SAVOR-TIMI-53 randomized 16,500 patients with type 2 diabetes with cardiovascular disease or multiple risk factors to saxagliptin or placebo. The companies said that the trial met the primary safety objective, in that it was noninferior to placebo, but that it did not meet the primary efficacy objective, in that it failed to show superiority to placebo in reducing the composite endpoint of cardiovascular death, nonfatal myocardial infarction, or nonfatal ischemic stroke. Saxagliptin, a DPP-4 inhibitor, is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Sanford Bernstein analyst Timothy Anderson wrote that saxagliptin will now “join the long list of other oral antidiabetics (OADs) that have similarly failed to show a definitive CV benefit over placebo.” He noted that the press release did not provide any information from the trial about the drug’s effect on the pancreas. The FDA is currently investigating the effects of saxagliptin and other DPP-4 inhibitors due to concerns over pancreatitis and pancreatic cancer.

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