Fenofibrate clinical studies
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]
Clinical Studies
Primary Hypercholesterolemia (Heterozygous Familial and Non familial) and Mixed Dyslipidemia
The effects of fenofibrate at a dose equivalent to 90 mg Antara 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 4).
 |
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).
Severe Hypertriglyceridemia
The effects of fenofibrate on serum triglycerides were studied in two randomized, double-blind, placebo-controlled clinical trials of 147 hypertriglyceridemic patients. Patients were treated for eight weeks under protocols that differed only in that one entered patients with baseline TG levels of 500 to 1500 mg/dL, and the other TG levels of 350 to 499 mg/dL. In patients with hypertriglyceridemia and normal cholesterolemia with or without hyperchylomicronemia , treatment with fenofibrate at dosages equivalent to 90 mg Antara per day decreased primarily very low density lipoprotein (VLDL) triglycerides and VLDL cholesterol Treatment of patients with elevated triglycerides often results in an increase of LDL-C (See Table 5).
| File:Fenofibrate09.jpg|thumb|800px]] |
The effect of Antara on serum triglycerides was studied in a double-blind, randomized, 3 arm parallel-group trial of 146. The study population was comprised of 61 % male and 39% female patients. Approximately 70% of patients had hypertension and 32% had diabetes. Patients were treated for eight weeks with either Antara equivalent to 90 mg taken once daily with meals, Antara equivalent to 90 mg taken once daily between meals, or placebo. Antara equivalent to 90 mg, whether taken with meals or between meals, had comparable effects on TG and all lipid parameters (See Table 6).
 |
The effect of ANTARA on cardiovascular morbidity and mortality has not been determined..[1]
References
- ↑ "ANTARA (FENOFIBRATE) CAPSULE [LUPIN PHARMA]". Retrieved 12 February 2014.