On September 2, Bristol-Myers Squibb released research data on the relationship between the Type 2 diabetes drug Onglyza (saxagliptin) and heart failure-related hospitalizations.
Results from the SAVOR (Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus) study showed that Onglyza was not related to increased risk for cardiovascular death, nonfatal heart attack, or nonfatal stroke, though the medication’s users demonstrated higher rates of hospitalization due to heart failure, where the heart does not pump blood adequately, Drug Safety Monitor reports. People with diabetes are at greater risk for cardiovascular problems, including heart failure.
“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 Dr. Deepak L. Bhatt, 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.”
The SAVOR study included 16,492 patients categorized at high risk for cardiovascular events also diagnosed with Type 2 diabetes. Patients were assigned to treatment with either Onglyza or a placebo. The researchers found no significant difference between groups in terms of cardiovascular death, nonfatal heart attack, or nonfatal stroke. Onglyza did not increase heart attack risk, though the drug was linked to a slight increase in heart failure-related hospitalizations.
Bristol-Myers Squibb said that while Onglyza met the primary safety objective of demonstrating no increased risk for cardiovascular death, nonfatal heart attack or nonfatal stroke, it did not prove superior to placebo for the same composite endpoint. Drug makers hope to develop a Type 2 diabetes drug that is not only safe but also beneficial to the heart.