Fenofibrate (FEN) is not only a lipid-lowering drug, but also has a uric acid-lowering effect, so it is often used for patients with gout and hyperuricemia complicated with metabolic syndrome. We often observe the effect of fibrates to increase the serum creatinine concentration; however, the actual situation, such as the frequency and degree, is unclear. We investigated the renal dysfunction due to FEN administration in patients receiving FEN in our clinic.
From December 2011 when FEN tablets (Tricor tablets, Lipidil tablets) were launched in Japan, to August 2020, we examined the renal function (serum creatinine: SCR, estimated glomerular filtration rate: eGFR) before and after FEN administration in 159 patients who received FEN in our clinic. The SCR significantly increased from 0.83 ± 0.15 mg / dL before administration to 0.97 ± 0.20 mg / dL 1-3 months after administration, and 0.99 ± 0.18 mg / dL 6 months after administration. The eGFR significantly decreased from 81.2 ± 18.8 mL / min / 1.73 m2 before administration to 69.2 ± 14.7 mL / min / 1.73 m21-3 months after administration and 66.7 ± 14.5 mL /min 6 months after administration. Increased SCR and decreased eGFR due to FEN administration were observed in 90% or more of the treated patients, and an increase in SCR of 1.0 mg / dL or more and a decrease in eGFR of 10 mL / min / 1.73 m2 or more were observed in about 70% of the patients. After 6 months, the renal function remained at the same level.
The renal function was examined in 21 patients who discontinued the administration of FEN, but continued to visit our clinic. The SCR decreased from 1.16 ± 0.29 mg / dL to 0.96 ± 0.22 mg / dL and the eGFR increased from 59.7 ± 19.6 mL / min / 1.73 m2 to 71.0 ± 19.8 mL / min2 2-4 months after discontinuation. Regardless of the length of drug administration, SCR and eGFR returned to the pre-dose level, respectively. Although the mechanism of renal dysfunction due to FEN has not been clarified, previous studies indicated the possibility that FEN could cause a reversible reduction in renal blood flow due to the suppression of prostaglandin production.
Renal dysfunction due to FEN was found to be markedly more frequent than the SCR elevation (0.99-3.03%) reported in post-marketing surveillance in Japan. However, FEN is effective in improving dyslipidemia and hyperuricemia; in addition, it is a drug that has been shown to exhibir broad clinical usefulness, such as the improvement of diabetic nephropathy and retinopathy, improvement of the vascular endothelial function, and suppression of cardiovascular events. Considering the balance between benefits and harm, it was considered important to perform regular renal function tests during the administration of FEN.
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