title: Rosiglitazone treatment and cardiovascular disease in the Veterans Affairs Diabetes Trial.
abstract: OBJECTIVE
  To evaluate the relationship between patterns of rosiglitazone use and cardiovascular (CV) outcomes in the Veterans Affairs Diabetes Trial (VADT).
  
  
  METHODS
  Time-dependent survival analyses, case-control and 1 : 1 propensity matching approaches were used to examine the relationship between patterns of rosiglitazone use and CV outcomes in the VADT, a randomized controlled study that assessed the effect of intensive glycaemic control on CV outcomes in 1791 patients with type 2 diabetes (T2D) whose mean age was 60.4 ± 9 years. Participants were recruited between 1 December 2000 and 31 May 2003, and were followed for 5-7.5 years (median 5.6) with a final visit by 31 May 2008. Rosiglitazone (4 mg and 8 mg daily) was initiated per protocol in both the intensive-therapy and standard-therapy groups. Main outcomes included a composite CV outcome, CV death and myocardial infarction (MI).
  
  
  RESULTS
  Both daily doses of rosiglitazone were associated with lower risk for the primary composite CV outcome [4 mg: hazard ratio (HR) 0.63, 95% confidence interval (CI) 0.49-0.81 and 8 mg: HR 0.60, 95% CI 0.49-0.75] after adjusting for demographic and clinical covariates. A reduction in CV death was also observed (HR 0.25, p < 0.001, for both 4 and 8 mg/day rosiglitazone); however, the effect on MI was less evident for 8 mg/day and not significant for 4 mg/day.
  
  
  CONCLUSIONS
  In older patients with T2D the use of rosiglitazone was associated with decreased risk of the primary CV composite outcome and CV death. Rosiglitazone use did not lead to a higher risk of MI.
authors.affiliation: Miami VA Healthcare System, GRECC, University of Miami, Miami, FL, USA.
authors.forename: H
authors.initials: H
authors.lastname: Florez
authors.affiliation: Phoenix VA Health Care Center, Department of Medicine, Phoenix, AZ, USA.
authors.forename: P D
authors.initials: PD
authors.lastname: Reaven
authors.affiliation: Hines VA Cooperative Studies Program, Coordinating Center, Hines VA Hospital, Hines, IL, USA.
authors.forename: G
authors.initials: G
authors.lastname: Bahn
authors.affiliation: Hines VA Cooperative Studies Program, Coordinating Center, Hines VA Hospital, Hines, IL, USA.
authors.forename: T
authors.initials: T
authors.lastname: Moritz
authors.affiliation: VA Cooperative Studies Program, Clinical Research Pharmacy Coordinating Center, University of New Mexico, Albuquerque, NM, USA.
authors.forename: S
authors.initials: S
authors.lastname: Warren
authors.affiliation: Miami VA Healthcare System, GRECC, University of Miami, Miami, FL, USA.
authors.forename: J
authors.initials: J
authors.lastname: Marks
authors.affiliation: Hines VA Cooperative Studies Program, Coordinating Center, Hines VA Hospital, Hines, IL, USA.
authors.forename: D
authors.initials: D
authors.lastname: Reda
authors.affiliation: Phoenix VA Health Care Center, Department of Medicine, Phoenix, AZ, USA.
authors.forename: W
authors.initials: W
authors.lastname: Duckworth
authors.affiliation: Miami VA Healthcare System, GRECC, University of Miami, Miami, FL, USA.
authors.forename: C
authors.initials: C
authors.lastname: Abraira
authors.affiliation: VA Center for Practice Management & Outcomes Research, VA Ann Arbor Healthcare System, Ann Arbor, MI, USA.
authors.forename: R
authors.initials: R
authors.lastname: Hayward
authors.affiliation: Hines VA Cooperative Studies Program, Coordinating Center, Hines VA Hospital, Hines, IL, USA.
authors.forename: N
authors.initials: N
authors.lastname: Emanuele
mesh_terms: D000368:Aged; D001786:Blood Glucose / Q000032:analysis; D002318:Cardiovascular Diseases / Q000209:etiology / Q000401:mortality*; D003924:Diabetes Mellitus, Type 2 / Q000150:complications / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology / Q000401:mortality*; D057216:Propensity Score; D016016:Proportional Hazards Models; D012307:Risk Factors; D000077154:Rosiglitazone; D045162:Thiazolidinediones / Q000008:administration & dosage*; D013997:Time Factors; D014481:United States; D014493:United States Department of Veterans Affairs
chemical_list: D001786:Blood Glucose; D007004:Hypoglycemic Agents; D045162:Thiazolidinediones; D000077154:Rosiglitazone
keywords: cardiovascular disease; older adults; rosiglitazone; type 2 diabetes