What is the recommended dosage of fenofibrate (fibric acid derivative) for an adult patient with hypertriglyceridemia?

Fenofibrate Dosing for Hypertriglyceridemia

Recommended Dosage Based on Triglyceride Severity

For adults with hypertriglyceridemia, fenofibrate dosing should be 54 mg to 160 mg once daily with meals, with the specific dose determined by triglyceride severity and renal function. 1

Severe Hypertriglyceridemia (≥500 mg/dL)

• Start fenofibrate 54-160 mg once daily immediately to prevent acute pancreatitis, regardless of other lipid parameters. 2, 1
• The initial dose range is 54-160 mg per day, individualized according to patient response. 1
• Maximum dose is 160 mg once daily. 1
• Reassess lipid levels at 4-8 week intervals and adjust dosage accordingly. 1
• This dosing provides 30-50% triglyceride reduction. 2, 3

Moderate Hypertriglyceridemia (200-499 mg/dL)

• For mixed dyslipidemia, start with fenofibrate 160 mg once daily. 1
• For isolated hypertriglyceridemia after lifestyle optimization, initiate 54-160 mg daily based on cardiovascular risk. 2
• If starting at 54 mg daily, recheck lipid panel at 4-8 weeks and increase to 160 mg daily if triglycerides remain ≥150 mg/dL. 3
• Continue therapy only if adequate response is achieved after 2 months at maximum dose. 1

Mild Hypertriglyceridemia (150-199 mg/dL)

• Fenofibrate is generally not first-line; prioritize lifestyle modifications and statin therapy if cardiovascular risk is elevated. 2
• Consider fenofibrate only if triglycerides remain elevated after 3 months of optimized lifestyle and statin therapy in high-risk patients. 2

Critical Dosing Adjustments

Renal Impairment

Fenofibrate dosing must be adjusted based on estimated glomerular filtration rate (eGFR): 1

• eGFR ≥60 mL/min/1.73 m²: Start 54 mg daily, may titrate to 160 mg daily based on response. 2
• eGFR 30-59 mL/min/1.73 m²: Start 54 mg daily; do not exceed this dose. 1
• eGFR <30 mL/min/1.73 m² or dialysis: Fenofibrate is contraindicated. 1

Monitor renal function within 3 months after initiation and every 6 months thereafter; discontinue immediately if eGFR persistently decreases to <30 mL/min/1.73 m². 2

Elderly Patients

• Dose selection should be based on renal function, as elderly patients are more likely to have decreased renal function. 1
• Use the renal dosing algorithm above for all elderly patients. 1

Administration Guidelines

• Always administer fenofibrate with meals to optimize bioavailability. 1
• Newer micronized formulations (fenofibrate-coated microgranules) may be taken without regard to meals, but standard fenofibrate tablets require food. 4
• Take once daily at the same time each day for consistency. 1

Monitoring Requirements

• Lipid panel at 4-8 weeks after initiation or dose adjustment. 3, 1
• Liver function tests (AST/ALT) at baseline, within 3 months, then every 6 months. 3
• Renal function (eGFR, creatinine) within 3 months, then every 6 months. 2
• Creatine kinase (CPK) at baseline and if muscle symptoms develop, especially when combining with statins. 2, 3

Critical Safety Considerations

When Combining with Statins

• Use lower statin doses (atorvastatin 10-20 mg maximum) to minimize myopathy risk. 2
• Never combine fenofibrate with gemfibrozil due to significantly higher rhabdomyolysis risk. 3
• Fenofibrate has a better safety profile than gemfibrozil when combined with statins. 2
• Monitor closely for muscle symptoms, particularly in patients >65 years or with renal disease. 2, 3

Contraindications

Fenofibrate is contraindicated in: 1

• Severe renal impairment (eGFR <30 mL/min/1.73 m²) or dialysis
• Active liver disease or unexplained persistent liver function abnormalities
• Preexisting gallbladder disease
• Known hypersensitivity to fenofibrate or fenofibric acid

Common Pitfalls to Avoid

• Do not delay fenofibrate initiation when triglycerides are ≥500 mg/dL while attempting lifestyle modifications alone—pharmacologic therapy is mandatory to prevent pancreatitis. 2
• Do not start with statin monotherapy when triglycerides are ≥500 mg/dL; statins provide only 10-30% triglyceride reduction, insufficient for pancreatitis prevention. 2
• Do not reduce fenofibrate dose if lipid goals are achieved; instead, withdraw therapy only if no adequate response after 2 months at maximum dose. 1
• Do not ignore secondary causes (uncontrolled diabetes, hypothyroidism, alcohol use, medications) before initiating fenofibrate, as addressing these may eliminate the need for pharmacotherapy. 2, 5

Expected Outcomes

• Fenofibrate 160-200 mg daily reduces triglycerides by 30-50% in most patients. 2, 6
• At 400 mg daily (higher than current FDA-approved dosing), historical studies showed 65% VLDL-triglyceride reduction in type IIB/IV patients. 7
• HDL-cholesterol typically increases, particularly in patients with low baseline values. 6, 7
• LDL-cholesterol may decrease by 20-30% in mixed dyslipidemia. 7