SAVOR-TIMI 53 Finds No Increase or Decrease in Ischemic Events with Saxagliptin in Diabetes Patients

"Unfortunately there's still no evidence that more rigid control of diabetes will reduce CV events," said Tony DeMaria, MD, MACC.

In patients with type 2 diabetes who have either had a history or are at risk of cardiovascular events, a dipeptidyl peptidase 4 (DDP-4) inhibitor saxagliptin neither increased nor decreased the rate of ischemic events, according to findings presented Sept. 2 at the ESC Congress 2013 in Amsterdam and simultaneously published in the New England Journal of Medicine.

The SAVOR-TIMI 53 trial was randomized and placebo-controlled, and looked at 16,492 patients for a median of 2.1 years. Results showed that a primary end point event — a composite of cardiovascular death, myocardial infarction, or ischemic stroke — occurred in 613 patients in the saxagliptin group and in 609 patients in the placebo group (7.3 percent and 7.2 percent respectively, according to two-year Kaplan-Meier estimates; hazard ratio with saxagliptin, 1.00; 95 percent confidence interval [CI], 0.89 to 1.12; P=0.99 for superiority; P<0.001 for noninferiority). Glycated hemoglobin levels were significantly lower in the saxagliptin group than in the placebo group at one year (7.6 percent vs. 7.9 percent), and at two years (7.5 percent vs. 7.8 percent) (P<0.001).

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"Saxagliptin was associated with significantly improved glycemic control and reduced the development and progress of microalbuminuria; however, it increased the risk of hospitalization for heart failure and the risk of hypoglycemic events," the investigators note. Moving forward, "other approaches are necessary to reduce cardiovascular risk in patients with diabetes," they conclude.

In an editorial comment, William R. Hiatt, MD, Sanjay Kaul, MD, FACC, and Robert J. Smith, MD, note that "new therapies targeting glycemic control may have cardiovascular benefit, but this has yet to be shown. The optimal approach to the reduction of cardiovascular risk in diabetes should focus on aggressive management of the standard cardiovascular risk factors rather than on intensive glycemic control," they add.

Keywords: Myocardial Infarction, Stroke, Kaplan-Meier Estimate, Dipeptidyl Peptidase 4, Diabetes Mellitus, Type 2, Risk Factors, Glycated Hemoglobin A, Dipeptides, Heart Failure, Cardiovascular Diseases, Hypoglycemic Agents, Confidence Intervals, Hospitalization

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