Abstract 17270: Outcomes of Patients With Type 2 Diabetes at High Risk of Cardiovascular Events Treated With Saxagliptin: Outcomes by Baseline HgbA1c
Background: No anti-diabetic agent has been proven to reduce cardiovascular disease (CVD) risk in patients with Type 2 Diabetes (T2DM). 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: In order to be eligible for the SAVOR-TIMI 53, patients had a HbA1c ≥6.5% and <12.0% within 6 months of randomization and either established CVD or multiple CVD risk factors. Patients were randomized 1:1 to saxagliptin 5mg qd (2.5mg in subjects with moderate/severe renal dysfunction) or matching placebo. The primary efficacy end point was the composite of CV death, non-fatal MI, or non-fatal ischemic stroke. The major secondary efficacy end point was the primary endpoint plus hospitalization for congestive heart failure, unstable angina or coronary revascularization. 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. The incidence of the primary endpoint increased as baseline glycemic control decreased (Figure). We plan to present a pre-specified analysis on the effects of saxagliptin on the primary and secondary efficacy endpoints at two years in patients based on baseline HgbA1c. Database lock occurred in June 2013, allowing presentation of these major subgroups at AHA.
Conclusions: Patients with good glycemic control have lower event rates than patients with poor glycemic control. Understanding the outcomes of patients treated with saxagliptin in groups with differing levels of baseline HgbA1c is critical in order to best utilize this drug in clinical practice.
- © 2013 by American Heart Association, Inc.