Table 1. Major clinical trials and epidemiological studies of fibrates.
| Study type | Population | No. | Study drug | Comparator | Primary outcome | Results | Additional findings | |
|---|---|---|---|---|---|---|---|---|
| HHS (1987) | RCT | Dyslipidemia | 4,081 | Gemfibrozil 1,200 mg/day | Placebo | Fatal and non-fatal MI or cardiac death | 34%a reduction | |
| VA-HIT (1999) | RCT | CHD | 2,531 | Gemfibrozil 1,200 mg/day | Placebo | Non-fatal MI or coronary death | 22%a reduction | |
| BIP (2000) | RCT | CHD | 3,090 | Bezafibrate 400 mg/day | Placebo | Fatal or nonfatal MI or sudden death | 9.4% reduction (NS) | 41.8% reduction in subgroup (HDL-C <35 mg/dL, TG ≥200 mg/dL) |
| LEADER (2002) | RCT | Lower PAD | 1,568 | Bezafibrate 400 mg/day | Placebo | CHD or stroke | 4% reduction (NS) | 40% reduction of non-fatal CHD |
| FIELD (2005) | RCT | T2DM | 9,795 | Fenofibrate 200 mg/day | Placebo | CHD death or non-fatal MI | 11% reduction (NS) | 24% reduction of non-fatal MI |
| ACCORD-Lipid (2010) | RCT | T2DM | 5,518 | Simvastatin plus fenofibrate 160 mg/day | Simvastatin | Non-fatal MI, non-fatal stroke, cardiovascular death | 8% reduction (NS) | 28.6% reduction in subgroup (HDL-C ≤34 mg/dL, TG ≥204 mg/dL) |
| ACCORDION (2017) | Post-trial f/u | T2DM | 4,644 | Simvastatin plus fenofibrate 160 mg/day | Simvastatin | Non-fatal MI, non-fatal stroke, cardiovascular death | 7% reduction (NS) | 27% reduction in subgroup (HDL-C ≤34 mg/dL, TG ≥204 mg/dL) |
| Three City Study (2015) | Cohort | Elderly without CVD | 7,484 | Statins or fibrates | No lipid lowering drugs | CHD or stroke | Fibrates: 34%a reduction of stroke, 12% increase in CHD (NS) | |
| ECLIPSE-REAL (2019) | Cohort | Metabolic syndrome | 10,705 | Statin plus fenofibrate 160 mg/day | Statin monotherapy | CHD, stroke, cardiovascular death | 26%a reduction | 36% reduction in subgroup (HDL-C <34 mg/dL, TG ≥204 mg/dL) |
HHS, Helsinki Heart Study; RCT, randomized controlled trial; MI, myocardial infarction; VA-HIT, Veterans Affairs HDL Intervention Trial; CHD, coronary heart disease; BIP, Bezafibrate Infarction Prevention; NS, non-significant; HDL-C, high-density lipoprotein cholesterol; TG, triglyceride; LEADER, Lower Extremity Arterial Disease Event Reduction; PAD, peripheral artery disease; FIELD, Fenofibrate Intervention and Event Lowering in Diabetes; T2DM, type 2 diabetes mellitus; ACCORD, Action to Control Cardiovascular Risk in Diabetes; ACCORDION, ACCORD Follow-On; f/u, follow-up; CVD, cardiovascular disease; ECLIPSE-REAL, Effectiveness of Fenofibrate Therapy in Residual Cardiovascular Risk Reduction in the Real World Setting.
aStatistically significant.