Fenofibrate (Page 2 of 7)

Clinical Trials

Hypercholesterolemia (Heterozygous Familial and Nonfamilial) and Mixed Dyslipidemia (Fredrickson Types IIa and IIb)

The effects of fenofibrate at a dose equivalent to 200 mg fenofibrate per day were assessed from four randomized, placebo-controlled, double-blind, parallel-group studies including patients with the following mean baseline lipid values: total-C 306.9 mg/dL; LDL-C 213.8 mg/dL; HDL-C 52.3 mg/dL; and triglycerides 191.0 mg/dL. Fenofibrate therapy lowered LDL-C, total-C, and the LDL-C/HDL-C ratio. Fenofibrate therapy also lowered triglycerides and raised HDL-C (see Table 1).

Table 1: Mean Percent Change in Lipid Parameters at End of Treatment *
Treatment Group Total-C LDL-C HDL-C TG
*
Duration of study treatment was 3 to 6 months
p = <0.05 vs. Placebo
Pooled Cohort
Mean baseline lipid values (n=646) 306.9 mg/dL 213.8 mg/dL 52.3 mg/dL 191.0 mg/dL
All FEN (n=361) -18.7% -20.6% +11.0% -28.9%
Placebo (n=285) -0.4% -2.2% +0.7% +7.7%
Baseline LDL-C > 160 mg/dL and TG < 150 mg/dL (Type IIa)
Mean baseline lipid values (n=334) 307.7 mg/dL 227.7 mg/dL 58.1 mg/dL 101.7 mg/dL
All FEN (n=193) -22.4% -31.4% +9.8% -23.5%
Placebo (n=141) +0.2% -2.2% +2.6% +11.7%
Baseline LDL-C > 160 mg/dL and TG ≥ 150 mg/dL (Type IIb)
Mean baseline lipid values (n=242) 312.8 mg/dL 219.8 mg/dL 46.7 mg/dL 231.9 mg/dL
All FEN (n=126) -16.8% -20.1% +14.6% -35.9%
Placebo (n=116) -3.0% -6.6% +2.3% +0.9%

In a subset of the subjects, measurements of apo B were conducted. Fenofibrate treatment significantly reduced apo B from baseline to endpoint as compared with placebo (-25.1% vs. 2.4%, p<0.0001, n=213 and 143, respectively).

Hypertriglyceridemia (Fredrickson Type IV and V)

The effects of fenofibrate on serum triglycerides were studied in two randomized, double-blind, placebo-controlled clinical trials 1 of 147 hypertriglyceridemia patients (Fredrickson Type 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).

Table 2: Effects of Fenofibrate Capsules (micronized) in Patients with Fredrickson Type IV/V Hyperlipidemia
*
= p<0.05 vs. Placebo
Study 1 Placebo Fenofibrate Capsules (micronized)
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 -46.2 *
VLDL Triglycerides 19 367 350 2.7 19 350 178 -44.1 *
Total Cholesterol 28 255 261 2.8 27 252 227 -9.1 *
HDL Cholesterol 28 35 36 4 27 34 40 19.6 *
LDL Cholesterol 28 120 129 12 27 128 137 14.5
VLDL Cholesterol 27 99 99 5.8 27 92 46 -44.7 *
Study 2 Placebo Fenofibrate Capsules (micronized)
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 -54.5 *
VLDL Triglycerides 29 537 571 18.7 33 543 205 -50.6 *
Total Cholesterol 44 272 271 0.4 48 261 223 -13.8 *
HDL Cholesterol 44 27 28 5.0 48 30 36 22.9 *
LDL Cholesterol 42 100 90 -4.2 45 103 131 45.0 *
VLDL Cholesterol 42 137 142 11.0 45 126 54 -49.4 *

The effect of fenofibrate on cardiovascular morbidity and mortality has not been determined.

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