Saxagliptin Falls Short in CVD Outcomes Study, SAVOR-TIMI 53

Shelley Wood

June 19, 2013

PRINCETON, NJ and WILMINGTON, DE — The SAVOR-TIMI 53 trial has failed to demonstrate the superiority of saxagliptin (Onglyza, Bristol-Myers Squibb/AstraZeneca) over placebo in reducing a composite end point of cardiovascular death, nonfatal MI, or nonfatal ischemic stroke when added to usual care in patients with type 2 diabetes with either a history of established CVD or multiple CVD risk factors [1].

The trial sponsors, Bristol-Myers Squibb and AstraZeneca, announced the top-line results from the trial early this morning. The full findings will be presented September 2, 2013 at the European Society of Cardiology (ESC) 2013 Congress. The trial did meet its "primary safety objective of noninferiority" vs placebo, a joint statement from the companies reads. SAVOR-TIMI-53 is part of an ESC hot-line session dedicated to risk factors and diabetes. The full schedule of ESC 2013 hot lines was published on the ESC website earlier this week.

Saxagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor approved in the US, Canada, Europe, and elsewhere as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Other, nonrandomized analyses had raised hopes that this class of drugs might have a protective effect on the vasculature of diabetes patients.

Saxagliptin was the first new diabetes drug to receive FDA approval after the issuance of new agency guidelines in July 2009, requiring companies to perform CV-outcomes studies with new diabetes drugs. The drug's clinical development program had been completed before the guidance, but because of the new rule, the company launched SAVOR-TIMI 53. The four-year-long trial had a target enrollment of 16 500 patients, and principal investigators for the trial are Dr Itamar Raz (Hadassah Medical Organization, Jerusalem, Israel) and Dr Deepak Bhatt (Brigham and Women's Hospital, Boston, MA).

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