Other individuals to remix, tweak, and build upon the work noncommercially, as long as the author is credited and the new creations are licensed below the identical terms. For reprints speak to: [email protected] Cite this article as: Patel P, Barkate H. Comparison of efficacy and safety of choline fenofibrate (fenofibric acid) to micronized fenofibrate in sufferers of mixed dyslipidemia: A randomized, open-label, multicenter clinical trial in Indian population. Indian J Endocr Metab 2016;20:67-71.2016 Indian Journal of Endocrinology and Metabolism | Published by Wolters Kluwer – MedknowPatel and Barkate: Efficacy and security of choline fenofibrate in Indian sufferers with mixed dyslipidemiaInitial remedy choices for mixed dyslipidemia contain life-style modification and statin therapy. Nevertheless, statin monotherapy is typically insufficient to normalize a number of lipid parameters.[3] The HDLC and TG levels are powerful predictor of cardiovascular risk even in patients treated using a statin and has achieved an optimum LDLC levels.[4,5] The addition of fibrates to statin therapy provides the prospective for general lipid control in patients with mixed dyslipidemia. Various results of short-term research in a variety of patient populations help this hypothesis.[6-9] Fenofibrate, which belongs for the class of fibrates, features a comparatively low potential for pharmacokinetic interaction at the same time as decrease rates of rhabdomyolysis with statins when compared to gemfibrozil.[10] Choline fenofibrate can be a newly created choline salt of fenofibric acid and is additional hydrophilic than fenofibrate. It does not demand very first pass hepatic metabolism to turn out to be active, because it dissociates to free fenofibric acid inside the gastrointestinal tract and quickly absorbed all through the gastrointestinal tract.[11] From the numerous fenofibrate formulations obtainable, choline fenofibrate could be the only formulation of fenofibrate which can be approved by the US FDA for coadministration with statins.[12] On the other hand, there is no Indian data readily available for efficacy and security of choline fenofibrate in patients of mixed dyslipidemia. Therefore, this study was planned to evaluate the efficacy and safety of choline fenofibrate in comparison to micronized fenofibrate among Indian patients of mixed dyslipidemia stabilized on statin therapy.Therapy groups and study designThe study design and style was multicenter, open-label, randomized, active controlled, comparative, and parallel group. Patients meeting eligibility criteria had been enrolled in the study and randomized in 1:1 ratio to obtain either choline fenofibrate delayed release 135 mg or micronized fenofibrate 160 mg as per computer generated randomization sheet.87729-39-3 Order There had been total six study visits: Screening stop by (day – 7), enrollment take a look at (day 1), follow-up pay a visit to 1 (day 15), follow-up visit two (day 29), follow-up visit three (day 57), and end of study visit (day 85).2-Bromo-4-fluorophenol uses Enrolled patients had been provided allocated study medicines for 3 months, and they were evaluated throughout the study period at the finish of two weeks, four weeks, 8 weeks, and 12 weeks for safety and efficacy evaluation.PMID:25040798 Lipid profile and creatinine phosphokinase (CPK) were repeated in the finish of four weeks, 8 weeks, and 12 weeks. Laboratory investigations, performed at the time of screening had been repeated at the end in the study.Primary and secondary finish pointsmethODsPatients and study sitesThe principal endpoint was percentage alter in serum TG levels at the finish of remedy (12 weeks) from baseline amongst two arms.