Fenofibric Acid/Fenofibrate and Liver disease

• Generic Name: fenofibrate
• Dosage Forms: n.a.
• Other Brand Names: Antara, Fenoglide, Lipofen, Tricor, Triglide, Lipidil Micro, Dom-Fenofibrate, Lipidil Supra, Lofibra, Lipidil EZ

Adjuncts to dietary therapy to decrease elevated serum total and LDL-cholesterol, triglyceride, and apolipoprotein B (apo B) concentrations, and to increase HDL-cholesterol concentrations in the management of primary hypercholesterolemia and mixed dyslipidemia, including heterozygous familial hypercholesterolemia and other causes of hypercholesterolemia. Additive antilipemic effects when used concomitantly with other antilipemic agents (e.g., colesevelam, ezetimibe).

Potential benefit unlikely to outweigh potential risks in patients with type IIa hyperlipoproteinemia and elevations of LDL-cholesterol only (because of toxicity, including malignancy, gallbladder disease, abdominal pain leading to appendectomy and other abdominal surgeries, and increased incidence of noncardiovascular and all-cause mortality, associated with the chemically and pharmacologically similar drug clofibrate [no longer commercially available in US]).

Fenofibric acid: Used in combination with a hydroxymethylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor (statin) to decrease triglyceride concentrations and increase HDL-cholesterol concentrations in patients with mixed dyslipidemia and CHD (or CHD risk equivalents) who are receiving optimal statin therapy; however, no incremental benefit on cardiovascular morbidity and mortality beyond that already established with statin monotherapy.

Adjuncts to dietary therapy in the management of severe hypertriglyceridemia. Efficacy in reducing risk of pancreatitis in patients with marked elevations in triglyceride concentrations (i.e., >2000 mg/dL) not established.

Effects on cardiovascular morbidity and mortality or noncardiovascular mortality not established. (See Effects on Morbidity and Mortality under Cautions.)

ACC/AHA cholesterol management guideline states that nonstatin drugs (e.g., fibric acid derivatives) do not provide acceptable atherosclerotic cardiovascular disease (ASCVD) risk reduction benefits compared to their potential for adverse effects in the routine prevention of ASCVD. May be useful as adjuncts to statin therapy in certain high-risk patients (e.g., patients with ASCVD, patients with LDL-cholesterol concentrations ≥190 mg/dL, patients 40–75 years of age with diabetes mellitus) who have a less-than-anticipated response to statins, are unable to tolerate even a less-than-recommended intensity of a statin, or are completely intolerant to statin therapy. However, because the addition of fenofibrate to simvastatin therapy has not been shown to provide an incremental benefit on cardiovascular morbidity and mortality beyond that already established with statin monotherapy, ACC/AHA cholesterol management guideline states that combination of fenofibrate and low- or moderate-intensity statin therapy may be considered only if benefits from ASCVD risk reduction or triglyceride lowering (when triglyceride concentrations >500 mg/dL) outweigh potential risks of adverse effects and drug interactions.