Abstract 17503: Outcomes of Patients With Type 2 Diabetes and Known Congestive Heart Failure Treated With Saxagliptin: Analyses of the SAVOR-TIMI 53 Study
Background: No anti-diabetic agent has been proven to reduce cardiovascular disease (CVD) in patients with Type 2 Diabetes (T2DM). Prior studies suggest certain oral hypoglycemic agents increase the risk of heart failure (CHF) and there are few therapies for patients with T2DM and CHF. The safety and efficacy of saxagliptin, a DPP-4 inhibitor, was tested in the phase 4, randomized, double-blind, placebo-controlled, SAVOR-TIMI 53 trial.
Methods: Patients with T2DM and established CVD or multiple CVD risk factors were eligible for SAVOR-TIMI 53. Patients were randomized 1:1 to saxagliptin 5mg qd (2.5mg in subjects with moderate/severe renal disease) or placebo. The primary end point was the composite of CV death, non-fatal MI, or non-fatal ischemic stroke. The major secondary efficacy end points were the primary endpoint + hospitalization for CHF, unstable angina or coronary revascularization) and hospitalization for CHF. A blinded events committee prospectively adjudicated all endpoints. Trial registration - NCT01107886 (www.clinicaltrials.gov).
Results: 16,492 subjects with T2DM and established CVD (78% of the population) or multiple cardiovascular risks factors alone (22%) were randomized at 779 sites in 26 countries between May, 2010 - December, 2011. The mean age was 65 years, 67% of patients were male, and the median duration of T2DM at randomization was 11.9 years. CHF was present in 13% (n=2105). Events were higher in patients with diabetes and CHF (Figure). We plan to present the effects of saxagliptin on the primary/secondary efficacy analyses at 2 years for the subgroup of patients with a history of CHF at randomization. Database lock occurred in June 2013, allowing presentation of this major subgroup at AHA.
Conclusions: Patients with T2DM and CHF have event rates higher than patients with T2DM alone. Understanding the outcomes in the subgroup of patients with known CHF treated with saxagliptin is critical in order to best utilize this drug in clinical practice.
- © 2013 by American Heart Association, Inc.