What should be the value of hypertriglyceridemia to start fenofibrate (Fenofibrate)?

From the Guidelines

Fenofibrate therapy should be initiated when triglyceride levels are 500 mg/dL or higher, as this level poses a significant risk of acute pancreatitis, warranting pharmacological intervention. However, treatment may be considered at lower levels (around 200-499 mg/dL) for patients at high cardiovascular risk or those who have not responded adequately to lifestyle modifications 1. Before starting fenofibrate, it's crucial to attempt lifestyle changes for 3-6 months, including dietary modifications, weight loss, and increased physical activity. The decision to start therapy should also take into account the patient's overall lipid profile, cardiovascular risk factors, and potential for drug interactions.

Key Considerations

• Fibrates, including fenofibrate, are the first-line treatment for patients with hypertriglyceridemia who are at risk of pancreatitis 1.
• Fenofibrate is usually started at a dose of 145 mg once daily, with adjustments based on renal function.
• Regular monitoring of lipid levels and liver function is necessary after initiating therapy to assess efficacy and safety.
• The use of fenofibrate may be beneficial in reducing cardiorenal risk in persons with hypertension and ASCVD or diabetes, particularly those with triglycerides ≥200 mg/dL and HDL-C ≤40 mg/dL 1.

Lifestyle Modifications

• Dietary counseling and weight loss are essential for patients with mild to moderate hypertriglyceridemia who are overweight or obese.
• Reduced intake of dietary fat and simple carbohydrates is recommended for patients with severe to very severe hypertriglyceridemia, in combination with drug treatment to reduce the risk of pancreatitis.
• Increased physical activity is also crucial in managing hypertriglyceridemia.

From the FDA Drug Label

The effects of fenofibrate on serum triglycerides were studied in two randomized, double-blind, placebo-controlled clinical trials of 147 hypertriglyceridemic patients Patients were treated for eight weeks under protocols that differed only in that one entered patients with baseline TG levels of 500 mg/dL to 1,500 mg/dL, and the other TG levels of 350 mg/dL to 500 mg/dL

The value of hypertriglyceridemia to start fenofibrate (Fenofibrate) is 350 mg/dL or higher 2.

• Key points:
  • Fenofibrate was studied in patients with baseline TG levels of 350 mg/dL to 500 mg/dL and 500 mg/dL to 1,500 mg/dL.
  • The medication is used to treat severe hypertriglyceridemia.

From the Research

Hypertriglyceridemia Treatment with Fenofibrate

The treatment of hypertriglyceridemia with fenofibrate is indicated for patients with triglyceride levels ≥500 mg/dL to reduce the risk of pancreatitis 3. However, fenofibrate can also be effective in patients with lower triglyceride levels.

Triglyceride Level Threshold for Fenofibrate Treatment

• The study by 4 included patients with triglyceride levels ≥150 mg/dL, and found that fenofibrate reduced triglyceride levels by a median of 60% after 4 months of treatment.
• Another study by 5 included patients with triglyceride levels ranging from 350 to 1,500 mg/dL, and found that fenofibrate significantly reduced triglyceride levels in both groups.
• The study by 3 focused on patients with very high triglyceride levels (> or =500 mg/dL), and found that fenofibrate reduced triglyceride levels by 53.8% after 8 weeks of treatment.
• A review of the literature by 6 recommends the use of fibrates, including fenofibrate, for the treatment of severe hypertriglyceridemia (≥500 mg/dL), as well as for patients with mild to moderate hypertriglyceridemia who do not respond to statin therapy.

Factors Associated with Triglyceride Reduction

• The study by 4 found that female sex, non-diabetic status, coronary artery disease, lower baseline triglyceride, and no statin use were independently associated with achievement of triglyceride <150 mg/dL.
• The study by 3 found that the addition of omega-3 fatty acids to fenofibrate therapy resulted in a statistically significant reduction in triglyceride levels.

Safety and Efficacy of Fenofibrate

• The study by 7 found that fenofibrate was well-tolerated and effective in reducing triglyceride levels, with a sustained effect during long-term treatment.
• The study by 5 found that fenofibrate was safe and effective in the treatment of type IV and V hyperlipoproteinemia, with significant reductions in triglyceride levels and few adverse events.