Saxagliptin misses efficacy mark in trial

Saxagliptin failed to meet its primary efficacy endpoint in a clinical trial designed to assess whether the drug reduced the risk of cardiovascular events when used alone or added to other diabetes medications.

Results of Phase IV SAVOR-TIMI-53 (Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus) were announced by its sponsors, Bristol-Myers Squibb and AstraZeneca. The companies reported that they are analyzing the data and plan to present results Sept. 2 at the European Society of Cardiology Congress in Amsterdam.

SAVOR-TIMI-53 is a multicenter, randomized, double-blind, placebo-controlled trial that aimed to enroll 16,500 patients with type 2 diabetes who were at high risk of a cardiovascular event due to a history of established cardiovascular disease or multiple risk factors. The study’s primary efficacy and safety outcomes were the composite endpoint of cardiovascular death, nonfatal MI or nonfatal ischemic stroke.

Secondary outcome measures included the composite endpoint of cardiovascular death, nonfatal MI, nonfatal ischemic stroke, hospitalization for heart failure, unstable angina pectoris or coronary revascularization; or any documented death.

Saxagliptin (Onglyza) met the primary safety measure of noninferiority compared with placebo but it did not meet the primary efficacy measure of superiority.

Saxagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, was approved by the FDA in 2009. It is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.