Summary of clinical trials of fibrates
| Study | Intervention | Patients | Follow-up/ treatment duration | Lipid outcome | Cardiovascular outcome |
|---|---|---|---|---|---|
| Bezafibrate | |||||
| BECAIT: de Faire et al. (6) | Bezafibrate 200 mg three times a day vs. placebo | 81 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. placebo | 3,090 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/dl | 6.2 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. placebo | 4,081 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. placebo | 2,531 men, CHD, veterans >74 years old, HDL cholesterol ≤40 mg/dl, LDL cholesterol ≤140 mg/dl, triglycerides ≤300 mg/dl | 5.1 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. placebo | Type 2 diabetes (mean A1C 7.5%), 418 patients, ≥1 coronary lesion | ≥3 years of treatment | Significant changes in total cholesterol, triglyceride, LDL cholesterol, HDL cholesterol | Less ↑ 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. placebo | Type 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.