title: Baseline characteristics of the patient population in the Saxagliptin Assessment of Vascular Outcomes Recorded in patients with diabetes mellitus (SAVOR)-TIMI 53 trial.
abstract: OBJECTIVE
  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.
  
  
  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.
  
  
  CONCLUSIONS
  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.affiliation: Diabetes Unit, Department of Medicine, Hadassah University Hospital, Jerusalem, Israel.
authors.forename: O
authors.initials: O
authors.lastname: Mosenzon
authors.forename: I
authors.initials: I
authors.lastname: Raz
authors.forename: B M
authors.initials: BM
authors.lastname: Scirica
authors.forename: B
authors.initials: B
authors.lastname: Hirshberg
authors.forename: C I
authors.initials: CI
authors.lastname: Stahre
authors.forename: P G
authors.initials: PG
authors.lastname: Steg
authors.forename: J
authors.initials: J
authors.lastname: Davidson
authors.forename: P
authors.initials: P
authors.lastname: Ohman
authors.forename: D L
authors.initials: DL
authors.lastname: Price
authors.forename: B
authors.initials: B
authors.lastname: Frederich
authors.forename: J A
authors.initials: JA
authors.lastname: Udell
authors.forename: E
authors.initials: E
authors.lastname: Braunwald
authors.forename: D L
authors.initials: DL
authors.lastname: Bhatt
mesh_terms: D000218:Adamantane / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000368:Aged; D015415:Biomarkers / Q000097:blood; D015992:Body Mass Index; D002318:Cardiovascular Diseases / Q000139:chemically induced / Q000150:complications / Q000453:epidemiology / Q000517:prevention & control*; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000150:complications / Q000188:drug therapy* / Q000276:immunology; D003925:Diabetic Angiopathies / Q000453:epidemiology / Q000503:physiopathology / Q000517:prevention & control; D003928:Diabetic Nephropathies / Q000453:epidemiology / Q000517:prevention & control; D004151:Dipeptides / Q000009:adverse effects / Q000627:therapeutic use*; D054873:Dipeptidyl-Peptidase IV Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D004359:Drug Therapy, Combination / Q000009:adverse effects; D005260:Female; D006801:Humans; D006943:Hyperglycemia / Q000453:epidemiology / Q000517:prevention & control; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000627:therapeutic use; D007333:Insulin Resistance; D008297:Male; D008875:Middle Aged; D050177:Overweight / Q000150:complications; D015995:Prevalence; D012307:Risk Factors; D012720:Severity of Illness Index
chemical_list: D015415:Biomarkers; D004151:Dipeptides; D054873:Dipeptidyl-Peptidase IV Inhibitors; D007004:Hypoglycemic Agents; C502994:saxagliptin; D000218:Adamantane
keywords: baseline characteristics; diabetes mellitus; trial patient