Fenofibric Acid (Page 6 of 8)
14.2 Primary Hypercholesterolemia (Heterozygous Familial and Nonfamilial) and Mixed Dyslipidemia
The effects of fenofibrate at a dose equivalent to fenofibric acid delayed-release capsules 135 mg once daily 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 (Table 5).
Treatment Group | Total – C ( mg / dL ) | LDL – C ( mg / dL ) | HDL – C ( mg / dL ) | TG ( mg / dL ) |
1 Duration of study treatment was 3 to 6 months | ||||
| ||||
Pooled Cohort | ||||
Mean baseline lipid values (n = 646) | 306.9 | 213.8 | 52.3 | 191.0 |
All Fenofibrate (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 | ||||
Mean baseline lipid values (n = 334) | 307.7 | 227.7 | 58.1 | 101.7 |
All Fenofibrate (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 | ||||
Mean baseline lipid values (n = 242) | 312.8 | 219.8 | 46.7 | 231.9 |
All Fenofibrate (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).
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