Anglo-Swedish drug major AstraZeneca (LSE: AZN) and US partner Bristol-Myers Squibb have announced mixed top-line results of the Phase IV SAVOR-TIMI-53 (Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus) clinical trial of diabetes drug Onglyza (saxagliptin).
In this study of adult patients with type 2 diabetes with either a history of established cardiovascular disease or multiple risk factors, Onglyza met the primary safety objective of non-inferiority, and did not meet the primary efficacy objective of superiority, for a composite endpoint of cardiovascular death, non-fatal myocardial infarction or non-fatal ischemic stroke, when added to a patient’s current standard of care (with or without other anti-diabetic therapies), as compared to placebo.
Doctors and investors had been awaiting results of the SAVOR trial with keen interest and a positive result could have encouraged increased use of the drug, noted a Reuters report. 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.
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