From the Guidelines
Fenofibrate (Lipotrol) should be used with caution in patients with chronic kidney disease (CKD), with dose adjustments required based on renal function, and is contraindicated in individuals with eGFR < 30 mL/min/1.73 m². For patients with mild to moderate CKD (eGFR 30-89 mL/min/1.73m²), the starting dose should be reduced to 48 mg daily, as indicated in the 2012 KDOQI clinical practice guideline for diabetes and CKD 1. Fenofibrate can cause reversible increases in serum creatinine, which doesn't necessarily indicate worsening kidney damage but requires monitoring. The medication is primarily metabolized by the kidneys, so reduced clearance in CKD patients leads to drug accumulation and potential toxicity. Common adverse effects in CKD patients include myopathy, rhabdomyolysis, and further kidney function deterioration. The risk increases when combined with statins, particularly in patients with compromised renal function.
Key Considerations
- Baseline kidney function should be assessed before initiating therapy, with regular monitoring of renal function, particularly during the first three months of treatment.
- Benefits of lipid management should be carefully weighed against these risks, with consideration of alternative lipid-lowering strategies in advanced CKD.
- The 2015 KDOQI US commentary on the 2013 KDIGO clinical practice guideline for lipid management in CKD also recommends that fibrates not be used in the population with high triglyceride levels and CKD, due to limited data on the risks and benefits of fibrates in patients with CKD 1.
- A more recent study published in 2022 in the Mayo Clinic Proceedings emphasizes the importance of lipid management in CKD patients, but does not provide specific guidance on the use of fenofibrate in this population 1.
From the FDA Drug Label
2.4 Impaired Renal Function Treatment with fenofibrate tablets should be initiated at a dose of 54 mg per day in patients having mild to moderately impaired renal function and increased only after evaluation of the effects on renal function and lipid levels at this dose. The use of fenofibrate tablets should be avoided in patients with severe renal impairment [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
Considerations for using Lipotrol (fenofibrate) in patients with Chronic Kidney Disease (CKD):
- For patients with mild to moderately impaired renal function, initiate treatment at a dose of 54 mg per day and increase only after evaluating the effects on renal function and lipid levels.
- Avoid use in patients with severe renal impairment. 2
From the Research
Considerations for Using Lipotrol (Fenofibrate) in Patients with Chronic Kidney Disease (CKD)
- The use of fenofibrate in patients with CKD requires careful consideration due to its potential effects on renal function 3.
- Fenofibrate has been shown to increase serum creatinine levels and decrease estimated glomerular filtration rate, particularly in patients with pre-existing renal impairment 3.
- However, these effects are often transient and reversible, and fenofibrate may also have long-term benefits in slowing the progression of renal function impairment and albuminuria 3.
- A study found that fenofibrate delayed the need for dialysis and reduced cardiovascular risk among patients with advanced CKD 4.
- The combination of fenofibrate and high-intensity statins may have additional benefits in reducing major adverse cardiac and cerebrovascular events 4.
- It is essential to monitor serum creatinine levels closely, especially in high-risk patients, and consider treatment discontinuation if increases in serum creatinine levels are ≥30% 3.
- The use of fenofibrate in patients with CKD should be individualized, taking into account the potential benefits and risks, as well as the patient's overall clinical profile 5, 6, 7.
Key Factors to Consider
- Renal function: Fenofibrate may worsen renal function, particularly in patients with pre-existing renal impairment 3.
- Cardiovascular risk: Fenofibrate may reduce cardiovascular risk in patients with advanced CKD 4.
- Combination therapy: The combination of fenofibrate and high-intensity statins may have additional benefits 4.
- Monitoring: Close monitoring of serum creatinine levels is essential, especially in high-risk patients 3.