Fibricor (Fenofibric Acid) - Summary

FIBRICOR SUMMARY

FIBRICOR is a lipid regulating agent available as tablets for oral administration. Each tablet contains 35 mg or 105 mg of fenofibric acid.

Severe Hypertriglyceridemia

FIBRICOR is indicated as adjunctive therapy to diet for treatment of severe hypertriglyceridemia (≥ 500 mg/dl). Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually obviate the need for pharmacologic intervention.

Levels of serum triglycerides > 1000 mg/dl may increase the risk of developing pancreatitis. The effect of FIBRICOR on reducing this risk has not been studied.

Primary Hyperlipidemia or Mixed Dyslipidemia

FIBRICOR is indicated as adjunctive therapy to diet to reduce elevated LDL-C, total-C, TG, and Apo B, and to increase HDL-C in patients with primary hypercholesterolemia or mixed dyslipidemia.

Considerations of Treatment

Fenofibrate at a dose equivalent to 105 mg of FIBRICOR was not shown to reduce coronary heart disease morbidity and mortality in a large, randomized controlled trial of patients with type 2 diabetes mellitus [ see Warnings and Precautions ].

The active moiety of FIBRICOR is fenofibric acid. The pharmacological effects of fenofibric acid have been extensively studied through oral administration of fenofibrate, which is converted in vivo to fenofibric acid.

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NEWS HIGHLIGHTS

Published Studies Related to Fibricor (Fenofibric Acid)

Variants in the APOA5 gene region and the response to combination therapy with statins and fenofibric acid in a randomized clinical trial of individuals with mixed dyslipidemia. [2011.12]
OBJECTIVE: Atherogenic dyslipidemia is highly associated with coronary heart disease and is characterized by elevated triglycerides (TG), low high-density lipoprotein cholesterol (HDL-C), and elevated low-density lipoprotein cholesterol (LDL-C). The combination of statins and fibrates is a common modality to treat individuals with atherogenic dyslipidemia. We sought to identify single nucleotide polymorphisms (SNPs) associated with HDL-C, TG, and apolipoprotein A1 (ApoA-I) response to combination therapy with statins and fenofibric acid (FA) in individuals with atherogenic dyslipidemia... CONCLUSION: In a population with atherogenic dyslipidemia, common SNPs and haplotypes within the APOA5-ZNF259 region are highly associated with HDL-C and ApoA-I response to combination therapy with statins and FA. Copyright (c) 2011 Elsevier Ireland Ltd. All rights reserved.

Single-dose bioequivalence of 105-mg fenofibric acid tablets versus 145-mg fenofibrate tablets under fasting and fed conditions: a report of two phase I, open-label, single-dose, randomized, crossover clinical trials. [2011.06]
BACKGROUND: Fenofibrate is used to treat primary hypercholesterolemia, mixed lipidemia, and hypertriglyceridemia in adults who do not respond to nonpharmacologic measures. Fenofibrate is a prodrug that is rapidly and completely hydrolyzed to fenofibric acid, the active moiety. A new orally administered agent, fenofibric acid, was developed as an alternative to fenofibrate. OBJECTIVE: Two separate studies were conducted to evaluate the bioequivalence of fenofibric acid relative to fenofibrate under fasted and fed (standard breakfast) conditions, characterize the pharmacokinetic profile, and assess the safety and tolerability of fenofibric acid... CONCLUSIONS: In these 2 single-dose studies, these healthy volunteers administered a single oral dose of 105-mg fenofibric acid met the US Food and Drug Administration regulatory criteria for assuming bioequivalence to a single oral dose of 145-mg fenofibrate tablets with respect to the rate and extent of fenofibric acid absorption in both fed and fasted states. Fenofibric acid at the dose studied was well tolerated in this population. Copyright (c) 2011 Elsevier HS Journals, Inc. All rights reserved.

Efficacy of fenofibric acid plus statins on multiple lipid parameters and its safety in women with mixed dyslipidemia. [2011.03.15]
The combination of fibrate and statin therapies may be a treatment option for women with multiple lipid abnormalities. We, therefore, initiated the present safety and efficacy analysis to address the paucity of such data in women with mixed dyslipidemia... In conclusion, these data suggest that a combination of fenofibric acid and a statin could be considered safe and efficacious for treating women with mixed dyslipidemia.

Long-term efficacy of adding fenofibric acid to moderate-dose statin therapy in patients with persistent elevated triglycerides. [2011.02]
OBJECTIVE: The objective of this study was to evaluate the long-term efficacy of adding fenofibric acid to moderate-dose statin therapy in patients at goal for low-density lipoprotein cholesterol (LDL-C) but with persistent hypertriglyceridemia... CONCLUSIONS: The addition of fenofibric acid to moderate-dose statin in patients whose LDL-C was optimal but whose triglycerides remained >200 mg/dL led to additional improvements in non-HDL-C, ApoB, HDL-C, and triglycerides that resulted in greater proportions of patients attaining optimal levels of the individual parameters as well as simultaneously achieving optimal levels of these parameters and LDL-C.

Achievement of lipid targets with the combination of rosuvastatin and fenofibric Acid in patients with type 2 diabetes mellitus. [2011.02]
OBJECTIVE: The objective of this study was to assess the proportion of patients with type 2 diabetes mellitus (T2DM) attaining individual and combined targets of low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), triglycerides (TG), non-HDL-C, and apolipoprotein B (ApoB) after treatment with rosuvastatin (R) + fenofibric acid (FA) compared with corresponding-dose R monotherapy... CONCLUSIONS: A significantly greater proportion of T2DM patients achieved individual and combined lipid targets when treated with the combination of R + FA than corresponding-dose R monotherapies.

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Clinical Trials Related to Fibricor (Fenofibric Acid)

Effect of Fenofibrate on Endothelial Function and High-density Lipoproteins (HDL) Physicochemical and Functional Characteristics in Patients With Coronary Heart Disease [Recruiting]
Fenofibrate is a drug that acts on the PPAR alpha receptors, increasing HDL-cholesterol and decreasing triglyceride levels. The interaction with these receptors has antiatherogenic actions by regulating the expression con key proteins that participate in vascular inflammation, plaque stability and thrombosis.

Fenofibrate reduces triglycerides and increases HDL-C in plasma. It also decreases small, dense LDL particles. The use of this drug has resulted in improvement of vascular function measured by endothelial function. Our hypotheses state that fenofibrate will improve: endothelial function, improve HDL antioxidant capacity and size distribution towards a predominance of small HDL particles.

A Pilot Study to Assess the Efficacy and Safety of LCQ908 Alone and in Combination With Fenofibrate or Lovaza� in Patients With Severe Hypertriglyceridemia [Recruiting]

A Study to Evaluate Fenofibrate Combination With Statin in Chinese Patients With Dyslipidemic [Recruiting]
Atherogenic dyslipidemia includes patients who have coronary heart disease (CHD) or CHD risk equivalents, whose TG level is not adequately controlled after statin monotherapy. According to the recent published EAS consensus, fibrate is suggested to be added to this type of patient who has insufficient improvement. The purpose of the study is to evaluate the efficacy on lipid control and the safety of adding fenofibrate in patients on a background of statin treatment.

Predictors of Response to Fenofibrate [Recruiting]
Fenofibrate is one of the best options for treating hypertriglyceridemia. In the majority of patients, fenofibrate lowers triglycerides (TG) by 24-55% and improves HDL- and LDL-cholesterol. However, the response to fenofibrate is highly variable and currently there are no screening tests to identify poor responders. Genetic and environmental factors may explain the high variability in response. Although exploratory in nature, this study is of clinical and public health importance because prediction of drug response among those with hypertriglyceridemia is clinically challenging and fenofibrate prescription costs are large ($90 to $130/patient/month); targeting the responsive patients at the outset will help improve treatment outcomes at a lower cost. If successful, the investigators will propose to conduct a large, randomized trial on the effect of pre-prescription genotyping on fenofibrate response.

A Trial in Adults With Type 1 Diabetes Mellitus Evaluating the Effects of Fenofibrate Versus Placebo on Macular Thickness and Volume [Not yet recruiting]
The purpose of this study is to evaluate the potential benefits of Fenofibrate in 300 adults with Type 1 diabetes mellitus who are at high risk of eye damage.

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