From the Guidelines
Fenofibrate can be used in patients with chronic kidney disease (CKD), but with caution and careful monitoring of renal function, as it may increase the risk of adverse effects, particularly in those with severe CKD (eGFR <30 mL/min/1.73m²) 1. When using fenofibrate in CKD patients, the following guidelines should be considered:
- For patients with mild to moderate CKD (eGFR 30-89 mL/min/1.73m²), a reduced dose of fenofibrate is recommended, typically starting at 48 mg daily 1.
- Fenofibrate should not be used in patients with severe CKD (eGFR <30 mL/min/1.73m²) due to increased risk of adverse effects 1.
- Baseline kidney function should be assessed before starting fenofibrate in CKD patients, and regular monitoring of renal function is necessary during treatment 1.
- Fenofibrate can potentially cause further kidney function deterioration in CKD patients, as it may increase serum creatinine levels by 10-20%, which is typically reversible upon discontinuation of the medication 1. Some key points to consider when using fenofibrate in CKD patients include:
- Alternative lipid-lowering medications like statins may be safer options for CKD patients, especially those with advanced disease 1.
- Any CKD patient on fenofibrate who experiences significant worsening of kidney function should have the medication discontinued 1.
- The mechanism behind fenofibrate's effect on kidney function involves altered creatinine secretion in the proximal tubules rather than actual kidney damage 1.
From the FDA Drug Label
The use of fenofibrate should be avoided in patients who have severe renal impairment [see Contraindications (4)]. Dose reduction is required in patients with mild to moderate renal impairment [see Dosage and Administration (2.4) and Clinical Pharmacology (12.3)]. Fenofibric acid is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function.
Fenofibrate is not entirely safe for patients with Chronic Kidney Disease (CKD).
- Patients with severe renal impairment should avoid using fenofibrate.
- Patients with mild to moderate renal impairment require a dose reduction.
- It is recommended to monitor renal function in patients with renal impairment taking fenofibrate 2.
- The pharmacokinetics of fenofibric acid was examined in patients with mild, moderate, and severe renal impairment, showing a 2.7-fold increase in exposure for fenofibric acid in patients with severe renal impairment 2.
From the Research
Fenofibrate Safety in CKD Patients
- The safety of fenofibrate in patients with chronic kidney disease (CKD) has been evaluated in several studies 3, 4, 5, 6, 7.
- A study published in 2012 found that low-dose fenofibrate therapy was safe and effective in reducing serum triglycerides and cholesterol in chronic dialysis patients, with no significant side effects 3.
- However, another study published in 2023 found that switching from fenofibrate to pemafibrate improved estimated glomerular filtration rate (eGFR) in CKD patients with hypertriglyceridemia, suggesting that fenofibrate may be associated with a risk of renal dysfunction 4.
- A prospective observational study published in 2022 found that discontinuation of fenofibrate in patients with CKD resulted in sustained reduction in serum creatinine levels and improvement in eGFR, suggesting that fenofibrate may be a cause of rise in serum creatinine levels 5.
- A national cohort study published in 2021 found that fenofibrate delayed the need for dialysis and reduced cardiovascular risk among patients with advanced CKD, suggesting that fenofibrate may have protective effects on kidney function and cardiovascular outcomes 6.
- A narrative review published in 2013 discussed the available literature on the effect of fenofibrate on the kidney, suggesting that fenofibrate-associated increases in serum creatinine levels may be transient and reversible, and that fenofibrate may not be a nephrotoxic drug 7.
Key Findings
- Fenofibrate may be associated with a risk of renal dysfunction, particularly in patients with CKD 4, 5.
- Fenofibrate may have protective effects on kidney function and cardiovascular outcomes in patients with advanced CKD 6.
- Close monitoring of serum creatinine levels is recommended, especially in high-risk patients 7.
- Fenofibrate-associated increases in serum creatinine levels may be transient and reversible 3, 7.