Saxagliptin (Onglyza) was no better than placebo at reducing major cardiovascular events in a large trial of high-risk patients with type 2 diabetes, according to the companies selling the drug in the U.S.
Results from the SAVOR-TIMI-53 trial (Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus) indicated saxagliptin failed to demonstrate superiority to placebo on a composite endpoint of cardiovascular death, nonfatal myocardial infarction, and nonfatal ischemic stroke, according to a statement from Bristol-Myers Squibb and AstraZeneca, which co-market saxagliptin.
Saxagliptin did meet the study's primary safety endpoint, the companies said, which was noninferiority relative to placebo for the same cardiovascular events used in the efficacy outcome.
Numerical results were not disclosed in the statement. "These preliminary SAVOR-TIMI-53 data are being analyzed and the study results will be submitted to the European Society of Cardiology (ESC) for potential presentation at the ESC Congress in September," the companies said.
The multinational SAVOR trial enrolled about 16,500 patients 40 and older with type 2 diabetes who had either a history of cardiovascular disease or multiple risk factors. They were randomized to receive saxagliptin or placebo in addition to their other medications, which could include other diabetes drugs such as metformin.
Secondary endpoints in the trial included all-cause mortality as well as a broader composite that included hospitalizations for heart failure, unstable angina, and coronary revascularization in addition to death, MI, and stroke.
John Gever
Senior Editor
John Gever, Senior Editor, has covered biomedicine and medical technology for 30 years. He holds a B.S. from the University of Michigan and an M.S. from Boston University. Now based in Pittsburgh, he is the daily assignment editor for MedPage Today as well as general factotum on the reporting side. Go Pirates/Penguins/Steelers!
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