AstraZeneca (NYSE: AZN) and Bristol-Myers Squibb Company (NYSE: BMY) today announced the full results of the SAVOR clinical trial in 16,492 adult patients with type 2 diabetes at high risk for cardiovascular events. In this study, Onglyza ® (saxagliptin) met the primary safety objective, demonstrating no increased risk for the primary composite endpoint of cardiovascular death, non-fatal myocardial infarction (MI) 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. Onglyza did not meet the primary efficacy endpoint of superiority to placebo for the same composite endpoint. Patients treated with Onglyza experienced improved glycemic control and reduced development and progression of microalbuminuria over two years as assessed in exploratory analyses.
The major secondary composite endpoint of cardiovascular death, non-fatal MI, non-fatal ischemic stroke or hospitalization for heart failure, unstable angina or coronary revascularization was balanced across the two arms. One component of the composite secondary endpoint, hospitalization for heart failure, occurred more in the Onglyza group compared to placebo. Rates of pancreatitis were low and balanced between Onglyza and placebo. Overall rates of malignancy were balanced, and the observed rates of pancreatic cancer were lower in the Onglyza group than in the placebo group. More patients in the Onglyza group reported at least one hypoglycemic event compared to placebo. Results were presented today during a Hot Line session at the ESC Congress 2013 in Amsterdam, Netherlands, and published in The New England Journal of Medicine.
In the past, questions have been raised about the safety of many diabetes treatments, in particular regarding their impact on the risk of cardiovascular death, heart attack or stroke. Led by the academic research organizations TIMI Study Group and Hadassah University Medical Center and conducted at more than 700 sites worldwide, SAVOR (Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus) was a randomized, double-blind, placebo-controlled trial of 16,492 patients designed to evaluate the cardiovascular safety and efficacy of Onglyza (saxagliptin) in adults with type 2 diabetes at risk for cardiovascular death, heart attack and stroke, compared to placebo.
“Given the correlation between diabetes and cardiovascular complications, there is a need for thorough assessments of the cardiovascular risks among therapies that improve glycemic control,” said Deepak L. Bhatt, MD, MPH, Senior Investigator of the TIMI Study Group, Brigham and Women’s Hospital, and a Principal Investigator for the trial. “The results from SAVOR add important evidence to the overall body of data to further define the clinical profile of saxagliptin for the treatment of type 2 diabetes.”