Efficacy and safety profile of fenofibrate-coated microgranules 130 mg, with and without food, in patients with hypertriglyceridemia and the metabolic syndrome: An 8-week, randomized, double-blind, placebo-controlled study

Abstract Background: The limited bioavailability of certain fenofibrate formulations necessitates administration with food, raising concerns about efficacy and compliance. There is a need for new formulations that have improved bioavailability and eliminate the requirement for administration with food. Objective: The aim of this study was to assess the food-related efficacy of a new formulation of micronized fenofibrate coated on inert microgranules (FF-μG) for the treatment of hypertriglyceridemia in patients exhibiting the metabolic syndrome. Methods: This was a randomized, double-blind, placebo-controlled, double-dummy, parallel-group study in patients who had fasting triglyceride (TG) concentrations ≥300 mg/dL and Results: One hundred forty-six patients took part in the study: 54 received FF-μG 130 mg with food, 42 received FF-μG 130 mg without food, and 50 received placebo. The groups were similar in terms of mean age (56 years), sex (59.5%–63.0% men; 37.0%–40.5% women), race (83.3%–100% white), mean body weight (92 kg), mean height (172 cm), mean fasting baseline TG concentrations (480 mg/dL), and other components of the metabolic syndrome. The 2 FF-μG groups (with and without food) showed similar improvements in the dyslipidemia associated with the metabolic syndrome: TG levels decreased a mean of 36.7% and 36.6%, respectively ( P P = NS). Significant increases from baseline in alanine aminotransferase were seen in both FF-μG groups (mean [SEM], 3.77 [2.60] and 11.69 [7.42] U/L, respectively; P ≤ 0.05 vs placebo); however, these increases were considered clinically significant in only 5 cases, none of them requiring discontinuation of study drug. Conclusions: This study found no inequivalence in the TG-lowering effects of the 2 fenofibrate regimens compared with placebo. Both regimens were well tolerated. Thus, FF-μG 130 mg administered without regard to meals appears to be efficacious and well tolerated for the treatment of hypertriglyceridemia in patients exhibiting the metabolic syndrome.