The cardiovascular safety and efficacy of some hypoglycemic including saxagliptin (Onglyza), an inhibitor of dipeptidyl peptidase 4 (DPP-4), is not well established.
16492 patients were randomized diagnosed with type 2 diabetes with a history of cardiovascular events or high risk to receive saxagliptin or placebo. Other medications for diabetes, including hypoglycemic, were permitted. The combined primary endpoint was cardiovascular death, myocardial infarction or ischemic stroke. The primary end point was observed in 613 patients in the saxagliptin group versus 609 in the placebo group (7.3% versus 7.2%, respectively, P = .99). The secondary end point of death, MI, stroke, hospitalization for unstable angina, coronary revascularization, or heart failure occurred in 1059 patients in the saxagliptin group versus placebo (12.8% versus 12.4%, P = 0.66). More saxagliptin patients were hospitalized for heart failure (3.5% versus 2.8%, P = 0.007). The incidence of acute and chronic pancreatitis was similar.
Conclusion:
Inhibition of DPP-4 saxagliptin does not increase or decrease the incidence of ischemic events despite the increase in the incidence of hospitalizations for heart failure. Although saxagliptin improve glycemic control, other measures are needed to reduce cardiovascular risk in patients with diabetes.
Deepak Bhatt
2013-09-02
Original title: SAVOR-TIMI 53: Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus Study
