Top line results from the phase 4 SAVOR-TIMI 53 clinical trial showed that saxagliptin did not meet the primary efficacy objective of superiority for the composite endpoint of CV death, nonfatal MI or nonfatal ischemic stroke compared with placebo, according to an announcement from Bristol-Myers Squibb and AstraZeneca.
However, early results suggest that saxagliptin (Onglyza) did meet the primary safety objective of noninferiority.
The preliminary SAVOR-TIMI 53 data are being analyzed and study results will be submitted to the European Society of Cardiology for potential presentation at the ESC Congress in September, according to the press release.
The randomized, double blind, placebo-controlled trial was designed to evaluate the safety and efficacy of saxagliptin, a dipeptidyl peptidase 4 inhibitor, added to current standard care vs. placebo for the long-term treatment of about 16,500 patients with type 2 diabetes and a history of CVD or multiple risk factors. The drug is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes in multiple clinical settings.
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Scirica BM. Am Heart J. 2011;162:818-825.