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Diabetes Metab Res Rev ; 29(5): 417-26, 2013 Jul.
Article in English | MEDLINE | ID: mdl-23564755

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.


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