Choline Fenofibrate Delayed Release Capsules Versus Conventional Fenofibrate Tablets for Dyslipidemia: A Randomized, Non-Inferiority Trial.

Background: Fibrates are the most efficient drugs to decrease serum triglycerides (TG). Several formulations of fenofibrate have been developed to optimize its pharmacologic properties. Objective: To evaluate the safety and efficacy of choline fenofibrate 135 mg delayed release capsules versus conventional fenofibrate 160 mg tablets in patients with dyslipidemia. Methods: Adult men and women with TG ≥150 mg/dl were enrolled in this study. Patients were randomized to receive either choline fenofibrate 135 mg delayed release capsules (test group) or conventional fenofibrate 160 mg tablets (control group) once daily for 12 weeks. Primary efficacy assessment was the mean percentage change from baseline in TG at week 12. Secondary efficacy assessments were the mean percentage change from baseline in LDL cholesterol, HDL cholesterol, VLDL cholesterol and total cholesterol at week 12; and assessment of global efficacy. Safety assessments included any adverse events or laboratory parameter abnormality, and assessment of global tolerability. Results: Out of 222 enrolled patients, 200 patients completed the study as per protocol. The mean percentage reduction from baseline in serum TG with the test drug (37.9 ± 27.5%) was non-inferior to the control drug (31.9 ± 38.0%) (P=0.205). Mean percentage change from baseline in the other serum lipid parameters was also comparable between the study groups. As per the global efficacy evaluation, a comparable proportion of patients (62.2% in the test group and 58.8% in the control group) showed an excellent response to study treatment (P=0.759). No adverse events were reported during the study. Conclusion: Choline fenofibrate 135 mg delayed release capsules are non-inferior to the conventional fenofibrate 160 mg tablets in terms of reduction in serum TG. Both the drugs are also comparable for change in the other serum lipid parameters, and are well tolerated.