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).
|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% †|
|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% †|
|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% †|
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).
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).
|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)|
|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 *|
|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)|
|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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