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

Abstract

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 16 496 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 2 years 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 31.2 kg/m² (+/-5.6), mean diabetes duration was 11.9 years (+/-8.9) and the mean HbA1c 8.0% (+/-1.4%). HbA1c  < 7% was most prevalent among North Americans (30.8%) and least among Asians (15.1%), whereas 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 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.

• Authors: O Mosenzon, I Raz, B M Scirica, B Hirshberg, C I Stahre, P G Steg, J Davidson, P Ohman, D L Price, B Frederich, J A Udell, E Braunwald, D L Bhatt
• Journal: Diabetes/metabolism research and reviews (Diabetes Metab Res Rev) Vol. 29 Issue 5 Pg. 417-26 (Jul 2013) ISSN: 1520-7560 [Electronic] England
• PMID: 23564755 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2013 John Wiley & Sons, Ltd.

Chemical References

• Biomarkers
• Dipeptides
• Dipeptidyl-Peptidase IV Inhibitors
• Hypoglycemic Agents
• saxagliptin
• Adamantane

Topics

• Adamantane (adverse effects, analogs & derivatives, therapeutic use)
• Aged
• Biomarkers (blood)
• Body Mass Index
• Cardiovascular Diseases (chemically induced, complications, epidemiology, prevention & control)
• Diabetes Mellitus, Type 2 (blood, complications, drug therapy, immunology)
• Diabetic Angiopathies (epidemiology, physiopathology, prevention & control)
• Diabetic Nephropathies (epidemiology, prevention & control)
• Dipeptides (adverse effects, therapeutic use)
• Dipeptidyl-Peptidase IV Inhibitors (adverse effects, therapeutic use)
• Drug Therapy, Combination (adverse effects)
• Female
• Humans
• Hyperglycemia (epidemiology, prevention & control)
• Hypoglycemic Agents (adverse effects, therapeutic use)
• Insulin Resistance
• Male
• Middle Aged
• Overweight (complications)
• Prevalence
• Risk Factors
• Severity of Illness Index