Fenofibrate (Page 3 of 8)
Hypertriglyceridemia (Fredrickson Type IV and V)
The effects of fenofibrate on serum triglycerides were studied in two randomized, double-blind, placebo-controlled clinical trials1 of 147 hypertriglyceridemia patients (Fredrickson Types IV and V). Patients were treated for eight weeks under protocols that differed only in that one entered patients with baseline triglyceride (TG) levels of 500 to 1500 mg/dL, and the other TG levels of 350 to 500 mg/dL. In patients with hypertriglyceridemia and normal cholesterolemia with or without hyperchylomicronemia (Type IV/V hyperlipidemia), treatment with fenofibrate at dosages equivalent to 200 mg fenofibrate per day decreased primarily very low density lipoprotein (VLDL) triglycerides and VLDL cholesterol. Treatment of patients with Type IV hyperlipoproteinemia and elevated triglycerides often results in an increase of low density lipoprotein (LDL) cholesterol (see Table 2).
| a p<0.05 vs. Placebo | ||||||||
| Study 1 | Placebo | Fenofibrate Capsules | ||||||
| Baseline TG levels 350 to 499 mg/dL | N | Baseline (Mean) | Endpoint (Mean) | % Change (Mean) | N | Baseline (Mean) | Endpoint (Mean) | % Change (Mean) |
| Triglycerides | 28 | 449 | 450 | -0.5 | 27 | 432 | 223 | -46.2a |
| VLDL Triglycerides | 19 | 367 | 350 | 2.7 | 19 | 350 | 178 | -44.1a |
| Total Cholesterol | 28 | 255 | 261 | 2.8 | 27 | 252 | 227 | -9.1a |
| HDL Cholesterol | 28 | 35 | 36 | 4 | 27 | 34 | 40 | 19.6a |
| LDL Cholesterol | 28 | 120 | 129 | 12 | 27 | 128 | 137 | 14.5 |
| VLDL Cholesterol | 27 | 99 | 99 | 5.8 | 27 | 92 | 46 | -44.7a |
| Study 2 | Placebo | Fenofibrate Capsules | ||||||
| Baseline TG levels 500 to 1500 mg/dL | N | Baseline (Mean) | Endpoint (Mean) | % Change (Mean) | N | Baseline (Mean) | Endpoint (Mean) | % Change (Mean) |
| Triglycerides | 44 | 710 | 750 | 7.2 | 48 | 726 | 308 | -54.5a |
| VLDL Triglycerides | 29 | 537 | 571 | 18.7 | 33 | 543 | 205 | -50.6a |
| Total Cholesterol | 44 | 272 | 271 | 0.4 | 48 | 261 | 223 | -13.8a |
| HDL Cholesterol | 44 | 27 | 28 | 5 | 48 | 30 | 36 | 22.9a |
| LDL Cholesterol | 42 | 100 | 90 | -4.2 | 45 | 103 | 131 | 45a |
| VLDL Cholesterol | 42 | 137 | 142 | 11 | 45 | 126 | 54 | -49.4a |
The effect of fenofibrate on cardiovascular morbidity and mortality has not been determined.
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