TABLE 1

Summary of clinical trials of fibrates

StudyInterventionPatientsFollow-up/ treatment durationLipid outcomeCardiovascular outcome
Bezafibrate
    BECAIT: de Faire et al. (6)Bezafibrate 200 mg three times a day vs. placebo81 men post-MI, <45 years old, dyslipidemia (predominantly hypertriglyceridemia)5 years of treatment↓Total cholesterol, ↓triglycerides, ↑HDL cholesterol, no change in LDL cholesterol↓Progression focal coronary atherosclerosis (P = 0.049), ↓incidence of coronary events (3 vs. 11, P = 0.02)
    BIP: BIP Study Group (7)Bezafibrate 400 mg/day vs. placebo3,090 patients, post-MI/stable angina, 45–74 years old, total cholesterol 180–250 mg/dl, HDL cholesterol ≤45 mg/dl, triglyceride ≤300 mg/dl, LDL cholesterol ≤180 mg/dl6.2 years (mean follow-up)↓Triglycerides (21%), ↑HDL cholesterol (18%)No difference in probability of coronary events (13.6 vs. 15.0%, P = 0.26), subgroup post hoc analysis in patients with triglyceride ≥200 mg/dl: ↓cumulative risk of coronary events (39.5%, P = 0.02)
Gemfibrozil
    HHS: Frick et al. (8)Gemfibrozil 600 mg twice daily vs. placebo4,081 men, asymptomatic, 40–55 years old, primary dyslipidemia (non-HDL cholesterol ≥200 mg/dl)5 years of treatment↓Total cholesterol, ↓triglycerides, ↓LDL cholesterol, ↓non-HDL cholesterol, ↑HDL cholesterol↓Incidence of CHD (34%, P < 0.02)
    VA-HIT: Rubins et al. (9)Gemfibrozil 1,200 mg/day vs. placebo2,531 men, CHD, veterans >74 years old, HDL cholesterol ≤40 mg/dl, LDL cholesterol ≤140 mg/dl, triglycerides ≤300 mg/dl5.1 years (median follow-up)↓Total cholesterol, ↓triglycerides, ↑HDL cholesterol, no change in LDL cholesterol↓Risk of coronary events (RR ↓ 22%, P = 0.006, absolute risk ↓ 4.4%), ↓risk of death from CHD, nonfatal MI, stroke (24%, P < 0.001)
Fibrates in patients with type 2 diabetes
    DAIS: DAIS Investigators (10)Fenofibrate 200 mg/day vs. placeboType 2 diabetes (mean A1C 7.5%), 418 patients, ≥1 coronary lesion≥3 years of treatmentSignificant changes in total cholesterol, triglyceride, LDL cholesterol, HDL cholesterolLess ↑ in stenosis diameter (2.11 vs. 3.65%, P = 0.02), smaller ↓ in lumen diameter (−0.06 vs. −0.10 mm, P = 0.029)
    SENDCAP: Elkeles et al. (11)Bezafibrate 400 mg/day vs. placeboType 2 diabetes, 164 patients, no CVD≥3 years of treatment↓Total cholesterol (−7 vs. −0.3%, P = 0.004), ↓triglycerides (−32 vs. 4%, P = 0.001), ↓total-to-HDL cholesterol ratio (−12 vs. −0.0%, P = 0.001), ↑HDL cholesterol (6 vs. −2%, P = 0.02)↓Combined incidence of probable ischemic change on resting electrocardiogram and MI (P = 0.01), no change in arterial disease
  • BECAIT, Bezafibrate Coronary Atherosclerosis Intervention Trial; BIP, Bezafibrate Infarction Prevention; DAIS, Diabetes Atherosclerosis Intervention Study; HHS, Helsinki Heart Study.