What is the starting dose of fenofibrate (fibric acid derivative) for a patient with severe hypertriglyceridemia?

From the Guidelines

The starting dose of fenofibrate for a patient with severe hypertriglyceridemia is typically 48-145 mg once daily, depending on the specific formulation used. For the micronized formulation (Tricor), the recommended starting dose is 48-145 mg daily with meals. For the delayed-release formulation (Trilipix), the starting dose is 45-135 mg once daily. Dosing should be individualized based on patient response and tolerability, with the goal of reducing triglyceride levels to below 500 mg/dL to decrease the risk of pancreatitis, as recommended by the 2013 Endocrine Society guidelines on diagnosis and management of hypertriglyceridemia 1. Fenofibrate works by activating peroxisome proliferator-activated receptor alpha (PPAR-α), which increases lipolysis and elimination of triglyceride-rich particles from plasma. Renal function should be assessed before initiating therapy, as dose adjustments are necessary for patients with renal impairment, according to the 2014 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults 1. Patients should be monitored for potential side effects including liver enzyme elevations, myopathy, and cholelithiasis. Fenofibrate should be taken with meals to enhance absorption, and patients should be advised that it may take several weeks to see the full lipid-lowering effects. It is also important to consider the patient's overall cardiovascular risk factors, such as central obesity, hypertension, abnormal glucose metabolism, and liver dysfunction, as recommended by the 2013 Endocrine Society guidelines 1. Additionally, the treatment goal for patients with moderate hypertriglyceridemia is a non–high-density lipoprotein cholesterol level of 30 mg per dL (0.78 mmol per L) higher than the low-density lipoprotein goal, as recommended by the NCEP ATP III. Fibrates, including fenofibrate, are the first-line treatment in patients with hypertriglyceridemia who are at risk of pancreatitis.

Some key points to consider when prescribing fenofibrate include:

• Starting with a low dose and titrating up as needed and tolerated
• Monitoring renal function and adjusting the dose accordingly
• Assessing for potential side effects and discontinuing the medication if necessary
• Considering the patient's overall cardiovascular risk factors and adjusting treatment accordingly
• Using fenofibrate in combination with other medications, such as statins, if necessary, but being aware of the potential increased risk of adverse effects.

Overall, the use of fenofibrate in patients with severe hypertriglyceridemia should be individualized and based on the patient's specific needs and risk factors, with the goal of reducing triglyceride levels and decreasing the risk of pancreatitis and cardiovascular disease.

From the FDA Drug Label

DOSAGE AND ADMINISTRATION Severe hypertriglyceridemia: Initial dose of 54 mg to 160 mg once daily. Maximum dose is 160 mg. (2. 3) The initial dose is 54 mg per day to 160 mg per day. Dosage should be individualized according to patient response and should be adjusted if necessary following repeat lipid determinations at 4 to 8 week intervals. The maximum dose is 160 mg once daily.

The starting dose of fenofibrate for a patient with severe hypertriglyceridemia is 54 mg to 160 mg once daily 2.

• The dose should be individualized according to patient response.
• The maximum dose is 160 mg once daily. Given the patient's triglyceride level of 726, the starting dose could be initiated at 54 mg per day, with adjustments made as necessary after evaluating the effects on lipid levels at this dose 2.

From the Research

Starting Dose of Fenofibrate for Severe Hypertriglyceridemia

The starting dose of fenofibrate for patients with severe hypertriglyceridemia is not explicitly stated in the provided studies. However, the following information can be gathered:

• Fenofibrate is used to treat severe hypertriglyceridemia, defined as triglyceride levels ≥ 500 mg/dL 3, 4.
• The typical dose of fenofibrate used in clinical trials is 130-160 mg per day 5, 6.
• In one study, patients with very high triglyceride levels (> 500 mg/dL) were treated with fenofibrate 130 mg per day, which resulted in a significant reduction in triglyceride levels 5.
• Another study compared the effects of fenofibrate 160 mg per day and omega-3 fatty acids 2 g per day on lipoprotein and metabolic profiles in patients with hypertriglyceridemia, and found that fenofibrate had better effects on lipoprotein and metabolic profiles 6.

Key Points to Consider

• The dose of fenofibrate used in clinical trials is typically 130-160 mg per day.
• Fenofibrate is effective in reducing triglyceride levels in patients with severe hypertriglyceridemia.
• The starting dose of fenofibrate for a patient with a triglyceride level of 726 mg/dL would likely be 130-160 mg per day, based on the available evidence 5, 6.