Table 4.
Subgroup analyses of cardiovascular outcome studies with fibrates
| Trial | Treatment (mg/day) | Patient characteristics | All patients |
Elevated triglycerides and low HDL-C subgroup | |||
|---|---|---|---|---|---|---|---|
| Primary endpoint | Relative risk reduction | Primary endpoint | Lipid criteria mmol/L | Relative risk reduction | |||
| Fibrate monotherapy vs. placebo | |||||||
| WHO trial202 (n= 5331) | Clofibrate 1600 | Upper-third of cholesterol values, without CHD | Non-fatal MI + CHD death | 20% (P < 0.05) | – | – | – |
| CDP203 (n= 3892) | Clofibrate 1800 (n= 1103) | CHD | Nonfatal MI + CHD death | 9% (P= 0.12) | – | – | – |
| HHS204,209 (n= 4081) | Gemfibrozil 1200 | Non-HDL-C ≥200 mg/dL without CHD | Fatal + non-fatal MI + cardiac death | 34% (P< 0.02) | As for all patients | TG >2.3 + HDL-C <1.08 | 65% (P= 0.01) |
| VA-HIT205,210 (n= 2531) | Gemfibrozil 1200 | CHD + low HDL-C (<40 mg/dL) | Non-fatal MI + CHD death | 22% (P= 0.006) | As for all patients | TG >2.03 + HDL-C ≤1.03 | 28% (P < 0.05) |
| BIP206 (n= 3090) | Bezafibrate 400 | Previous MI or angina | Fatal + non-fatal MI + sudden death | 9.4% (P= 0.26) | As for all patients | TG ≥2.26 + HDL-C <0.91 | 42% (P = 0.02) |
| FIELD106,207 (n= 9795) | Fenofibrate 200 | Type 2 diabetes (22% with CVD) | Non-fatal MI + CHD death | 11% (P= 0.16) | Total CV events | TG ≥2.30 + low HDL-Ca | 27% (P = 0.005) |
| Statin-fibrate vs. statin monotherapy | |||||||
| ACCORD Lipid107 (n= 5518) | Fenofibrate 160 + simvastatin | Type 2 diabetes (37% with CVD) | CVD death, nonfatal MI + non-fatal stroke | 8% (P= 0.32) | As for all patients | TG ≥2.30 + HDL-C ≤0.88 | 31%; P-value not reported |
aIn FIELD, low HDL-C was defined as <1.03 mmol/L in men and <1.29 mmol/L in women.
CHD, coronary heart disease; CV, cardiovascular; MI, myocardial infarction; WHO, World Health Organization.
ACCORD, Action to Control Cardiovascular Risk in Diabetes; BIP, Bezafibrate Infarction Prevention study; CDP, Coronary Drug Project; FIELD, Fenofibrate Intervention and Event Lowering in Diabetes study; HHS, Helsinki Heart Study; VA-HIT, Veterans Affairs HDL Intervention Trial.