What is fenofibrate (Fibric acid derivative)?

From the Guidelines

Fenofibrate is a fibrate medication used to treat high cholesterol and triglyceride levels, primarily by reducing triglyceride production in the liver and increasing the removal of harmful particles from the bloodstream. According to the most recent and highest quality study, fenofibrate may be considered concomitantly with a low- or moderate-intensity statin only if the benefits from ASCVD risk reduction or triglyceride lowering when triglycerides are 500 mg/dL are judged to outweigh the potential risk for adverse effects 1. The FIELD study, which assessed the effect of fenofibrate in type 2 diabetes, found that fenofibrate therapy was associated with a relative risk reduction of 11% in the primary endpoint of coronary heart disease death and non-fatal MI, although this did not reach statistical significance 1.

Key Points to Consider

• Fenofibrate is typically prescribed at doses ranging from 48 mg to 145 mg once daily, taken with meals to enhance absorption.
• It's often used in combination with statins or other cholesterol-lowering medications for patients with mixed dyslipidemia.
• Common brand names include Tricor, Antara, and Fenoglide.
• Patients should be aware that fenofibrate may cause side effects such as stomach pain, nausea, and muscle pain.
• Regular blood tests are necessary while taking this medication to monitor liver function and lipid levels.
• Fenofibrate works by activating peroxisome proliferator-activated receptor alpha (PPAR-alpha), which regulates genes involved in fat metabolism, making it particularly effective for lowering triglycerides and increasing HDL (good) cholesterol.

Safety Considerations

• Gemfibrozil should not be initiated in patients on statin therapy due to an increased risk for muscle symptoms and rhabdomyolysis 1.
• Fenofibrate may be considered concomitantly with a low- or moderate-intensity statin, but the benefits and potential risks must be carefully weighed.
• Renal status should be evaluated before fenofibrate initiation, within 3 months after initiation, and every 6 months thereafter, with assessment of both serum creatinine level and eGFR based on creatinine 1.
• Fenofibrate should not be used if moderate or severe renal impairment is present, defined as eGFR <30 mL/min per 1.73 m2 1.

From the FDA Drug Label

Fenofibrate tablets, USP are a lipid regulating agent available as tablets for oral administration. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester Fenofibrate, USP is insoluble in water.

Fenofibrate is a lipid regulating agent used to treat high cholesterol and triglyceride levels. It works by increasing the breakdown and removal of triglycerides from the blood, and by increasing the production of high-density lipoprotein (HDL) cholesterol, also known as "good" cholesterol. 2

From the Research

What is Fenofibrate

• Fenofibrate is a fibric acid derivative indicated for the treatment of severe hypertriglyceridaemia and mixed dyslipidaemia in patients who have not responded to nonpharmacological therapies 3, 4, 5.
• It is used to improve the lipid profile, particularly triglyceride and high-density lipoprotein-cholesterol levels, in patients with dyslipidaemia 3, 4, 6.
• Fenofibrate has nonlipid, pleiotropic effects, such as reducing levels of fibrinogen, C-reactive protein, and various pro-inflammatory markers, and improving flow-mediated dilatation 3, 4, 6.

Mechanism of Action

• The lipid-modifying effects of fenofibrate are mediated by the activation of peroxisome proliferator-activated receptor-α 3, 4, 5.
• Fenofibrate promotes a shift from small, dense, atherogenic LDL particles to larger, less dense LDL particles 3, 4.

Clinical Use

• Fenofibrate is generally well tolerated when administered alone or in combination with a statin 3, 4, 7.
• Combination therapy with a statin plus fenofibrate generally improves the lipid profile to a greater extent than monotherapy with either agent in patients with dyslipidaemia and/or type 2 diabetes mellitus or the metabolic syndrome 3, 4, 7.
• Fenofibrate may offer important treatment alternatives as a second-line therapy in several circumstances, including in combination with a statin for patients with mixed dyslipidemias not at goals on statin mono-therapy 7.