Baseline characteristics of the patient population in the Saxagliptin Assessment of Vascular Outcomes Recorded in patients with diabetes mellitus (SAVOR)-TIMI 53 trial

Background and aims SAVOR-TIMI 53 was designed to study the effects of the DPP-4 inhibitor saxagliptin on cardiovascular outcomes in high risk type 2 diabetes patients with diverse levels of diabetes control and background anti-diabetic drugs. The goal of this article is to describe the baseline characteristics of this hypothesis driven study. Materials and methods A total of 16496 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 (78.3%) or with two additional cardiovascular risk factors (21.7%) were randomised to saxagliptin or placebo. Biomarkers of inflammation and insulin resistance were taken at baseline and 2years later in order to correlate saxagliptin effect on cardiovascular outcome to its effect on inflammation and insulin resistance. Results Mean [+/-standard deviation (SD)] age was 65.0 (+/-8.6)years, 66.9% were male, body mass index was 31.2kg/m(2) (+/-5.6), mean diabetes duration was 11.9years (+/-8.9) and the mean HbA(1c) 8.0% (+/-1.4%). HbA(1c)<7% was most prevalent among North Americans (30.8%) and least among Asians (15.1%), whereas HbA(1c)>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 as follows: no medication (5.4%), 1 oral anti-diabetic 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 with users of 2 OAD. Baseline statin use (78.3% overall) varied by region. Conclusion The SAVOR-TIMI 53 patient population, with differing background diabetes control and anti-diabetic treatment, provides global representation of diabetic patients with established cardiovascular disease or at high risk for cardiovascular disease and is well-positioned to determine the effect of saxagliptin on cardiovascular events. Copyright (c) 2013 John Wiley & Sons, Ltd.