Mosenzon, O., Raz, I., Scirica, B. M., Hirshberg, B., Stahre, C. I., Steg, P. G., Davidson, J., Ohman, P., Price, D. L., Frederich, B., Udell, J. A., Braunwald, E., Bhatt, D. L. Baseline characteristics of patient population in the Saxagliptin Assessment of Vascular Outcomes Recorded in patients with diabetes mellitus (SAVOR) - TIMI 53 Trial Diabetes Metab Res Rev. 2013;NA(NA):NA.

BACKGROUND AND AIMS: SAVOR-TIMI-53 was designed to study the effects of the DPP4 inhibitor saxagliptin on cardiovascular (CV) outcomes in high risk type 2 diabetes patients with diverse levels of diabetes control and background anti-diabetic drugs (ADD). The goal of this paper is to describe the baseline characteristics of this hypothesis driven study. MATERIALS AND METHODS: A total of 16,500 diabetic patients from North America (31.9%), Western Europe (26.0%), Eastern Europe (17.3%), Latin America (16.4%) and Asia (8.3%), with either established cardiovascular disease (CVD) (78.3%) or with ≥ 2 additional CV risk factors (21.7%) were randomized to saxagliptin or placebo. Biomarkers of inflammation and insulin resistance (IR) were taken at baseline and 2 years later, in order to correlate saxagliptin effect on CV outcome to its effect on inflammation and IR.

RESULTS: Mean (+/-SD) age was 65.0 (+/-8.6) years, 66.9% were males, BMI was 31.2 kg/m2 (+/-5.6), mean diabetes duration was 12.0 years (+/-8.6) and the mean HbA1c 8.0% (+/-1.4%). HbA1c<7% was most prevalent among North Americans (30.8%) and least among Asians (15.1%), while HbA1c>9% was 30.7% in Latin America 27.0% in Asia, and 15.1% in North America. Diabetic retinopathy was reported in 12.3% of patients, nephropathy in 17.7% and amputation in 2.5%. Diabetic treatments categories were: No medication (5.4%), 1 Oral Antidiabetic Drug (OAD) (25.0%), ≥ 2 OAD (27.7%), and/or insulin (40.9%). The prevalence of micro-albuminuria was twice as high among insulin users compared to users of ≥2 OAD. Baseline statin use (73.8% overall) varied by region.

CONCLUSION: The SAVOR-TIMI 53 patient population, with differing background diabetes control and antidiabetic treatment provides global representation of diabetic patients with established CVD or at high risk for CVD and is well positioned to determine the effect of saxagliptin on CV events. This article is protected by copyright. All rights reserved.

Trial: SAVOR-TIMI 53