title: Effects of fenofibrate on cardiovascular events in patients with diabetes, with and without prior cardiovascular disease: The Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study.
abstract: BACKGROUND
  In the FIELD study, comparison of the effect of fenofibrate on cardiovascular disease (CVD) between those with prior CVD and without was a prespecified subgroup analysis.
  
  
  METHODS
  The effects of fenofibrate on total CVD events and its components in patients who did (n = 2,131) and did not (n = 7,664) have a history of CVD were computed by Cox proportional hazards modeling and compared by testing for treatment-by-subgroup interaction. The analyses were adjusted for commencement of statins, use of other CVD medications, and baseline covariates. Effects on other CVD end points were explored.
  
  
  RESULTS
  Patients with prior CVD were more likely than those without to be male, to be older (by 3.3 years), to have had a history of diabetes for 2 years longer at baseline, and to have diabetic complications, hypertension, and higher rates of use of insulin and CVD medications. Discontinuation of fenofibrate was similar between the subgroups, but more patients with prior CVD than without, and also more placebo than fenofibrate-assigned patients, commenced statin therapy. The borderline difference in the effects of fenofibrate between those who did (hazard ratio [HR] 1.02, 95% CI 0.86-1.20) and did not have prior CVD (HR 0.81, 95% CI 0.70-0.94; heterogeneity P = .045) became nonsignificant after adjustment for baseline covariates and other CVD medications (HR 0.96, 95% CI 0.81-1.14 vs HR 0.78, 95% CI 0.67-0.90) (heterogeneity P = .06).
  
  
  CONCLUSIONS
  Our findings do not support treating patients with fenofibrate differently based on any history of CVD, in line with evidence from other trials.
authors.affiliation: Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Vic, Australia. tony@ctc.usyd.edu.au
authors.forename: Andrew
authors.initials: A
authors.lastname: Tonkin
authors.forename: David
authors.initials: D
authors.lastname: Hunt
authors.forename: Merryn
authors.initials: M
authors.lastname: Voysey
authors.forename: Antero
authors.initials: A
authors.lastname: Kesäniemi
authors.forename: Andrew
authors.initials: A
authors.lastname: Hamer
authors.forename: Jonathon
authors.initials: J
authors.lastname: Waites
authors.forename: Leo
authors.initials: L
authors.lastname: Mahar
authors.forename: Stewart
authors.initials: S
authors.lastname: Mann
authors.forename: Paul
authors.initials: P
authors.lastname: Glasziou
authors.forename: Peta
authors.initials: P
authors.lastname: Forder
authors.forename: John
authors.initials: J
authors.lastname: Simes
authors.forename: Anthony C
authors.initials: AC
authors.lastname: Keech
mesh_terms: D000368:Aged; D002318:Cardiovascular Diseases / Q000150:complications / Q000188:drug therapy* / Q000453:epidemiology; D048909:Diabetes Complications / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D005260:Female; D011345:Fenofibrate / Q000008:administration & dosage*; D005500:Follow-Up Studies; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use; D000960:Hypolipidemic Agents / Q000008:administration & dosage*; D015994:Incidence; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D016896:Treatment Outcome
chemical_list: D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D000960:Hypolipidemic Agents; D011345:Fenofibrate