Comparison of efficacy and safety of choline fenofibrate (fenofibric acid) to micronized fenofibrate in patients of mixed dyslipidemia: A randomized, open-label, multicenter clinical trial in Indian population

Abstract

Introduction:Choline fenofibrate is a newly developed choline salt of fenofibric acid, which is more hydrophilic than fenofibrate. This study was initiated to evaluate the safety and efficacy of choline fenofibrate in comparison to micronized fenofibrate among Indian patients of mixed dyslipidemia.Methods:A multicenter, open-label, randomized, active controlled, comparative, parallel group study was conducted at around 10 centers spread all across the country. Mixed dyslipidemia patients (serum triglycerides [TG] levels between 150 and 500 mg/dl), aged 18–70 years and taking stable statin dose for 8 weeks were randomized to choline fenofibrate 135 mg delayed release tablets and micronized fenofibrate 160 mg tablets once daily for 12 weeks. The primary endpoint of the study was percentage change in serum TG level at the end of 12 weeks.Results:A total of 226 patients were enrolled in this study, of which 116 patients were administered choline fenofibrate and 110 patients were administered micronized fenofibrate. At the end of 12 weeks, there was a significant reduction in TG level (34.24% in choline fenofibrate group and 38.13% reduction in micronized fenofibrate group). However, the difference between group was not statistically different (P = 0.471). Similarly, there was a significant increase in high-density lipoprotein cholesterol at the end of 12 weeks (10% increase in choline fenofibrate group and 9% increase in micronized fenofibrate group); but the difference between the group was not statistically significant (P = 0.598). Both the treatment was safe and well tolerated.Conclusion:Choline fenofibrate delayed release 135 mg is as safe and effective as 160 mg of micronized fenofibrate in Indian patients with mixed dyslipidemia.

Effect of Fenofibrate Medication on Renal Function

“…Fenofibrate resulted in a 38% reduction in TG levels by treatment week 12. 35) When TG was 500 mg/dL, a reduction of 190 mg/dL was noted after treatment. Considering patient compliance, a fenofibrate treatment effect was defined as a serum TG reduction >90 mg/dL.…”

The role of peroxisome proliferator-activated receptor in the treatment of non-alcoholic fatty liver disease

“…), fatty acids (FAs) and very low-density lipoprotein (VLDL), secretions were decreased more than in the control group (40). In a clinical trial, Piyush Patel et al (41) found that the TG level was reduced in patients who were administered fenofibrate (116 patients were administered choline fenofibrate and 116 patients were administered micronized fenofibrate). Another research group also found that adding pentoxifylline to fenofibrate had a beneficial effect on a direct marker linked to matrix deposition (hyaluronic acid), a cytokine/growth factor linked to liver fibrosis (transforming growth factor beta 1), the inflammatory pathway, insulin resistance and liver stiffness, in non-alcoholic fatty liver patients treated with fenofibrate (300 mg daily) plus pentoxifylline (1200 mg per day) for 24 weeks (42).…”

Comparison of efficacy and safety of fixed dose combination of rosuvastatin and choline fenofibrate to fixed dose combination of rosuvastatin and fenofibrate in patients of mixed dyslipidemia: A randomized, open-label, multicentre clinical trial in Indian population

“…Earlier in a trial, we have demonstrated that choline fenofibrate is as effective and safe as micronized fenofibrate in mixed dyslipidemia among Indian population. [ 2 ] The present study was planned to evaluate the efficacy and safety of fixed dose combination (FDC) of choline fenofibrate and rosuvastatin in comparison to rosuvastatin and fenofibrate combination among Indian patients of mixed dyslipidemia.…”