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. 2024 Apr 7;16(4):e57777.
doi: 10.7759/cureus.57777. eCollection 2024 Apr.

Clinical Efficacy and Safety of Low-Dose Pemafibrate in Patients With Severe Renal Impairment: A Retrospective Study

Affiliations

Clinical Efficacy and Safety of Low-Dose Pemafibrate in Patients With Severe Renal Impairment: A Retrospective Study

Hisato Shima et al. Cureus. .

Abstract

Background: The management of hypertriglyceridemia in patients with chronic kidney disease (CKD) is important. Pemafibrate, a novel selective peroxisome proliferator-activated receptor-alpha modulator with less toxic effects on liver and kidney function than those of other fibrates, has recently been approved for the treatment of patients with an estimated glomerular filtration rate (eGFR) lower than 30 mL/min/1.73 m2. However, the efficacy and safety of pemafibrate in patients with severe renal impairment have not yet been established.

Methods: This single-center, retrospective observational study included 12 outpatients with CKD and hypertriglyceridemia, who were newly started on low-dose pemafibrate (0.1 mg/day) treatment between December 2021 and May 2023 and whose eGFRs were less than 30 mL/min/1.73 m2 at baseline. Blood samples were collected before and at 12 weeks after pemafibrate treatment.

Results: After 12 weeks of treatment, the serum triglyceride level was significantly decreased, whereas the high-density lipoprotein cholesterol level was significantly increased. The serum alanine aminotransferase, alkaline phosphatase, gamma-glutamyl transpeptidase, and uric acid levels were also significantly decreased, without worsening of the eGFR and serum creatinine levels. In the subgroup analysis, there were no significant differences in the changes in clinical parameters regardless of statin use and CKD stage at baseline.

Conclusions: Low-dose pemafibrate administration in patients with severe renal impairment resulted in significant improvements in triglyceride, high-density lipoprotein cholesterol, and serum uric acid levels, and liver function, without adverse events.

Keywords: chronic kidney disease (ckd); hypertriglyceridemia; pemafibrate; severe renal impairment; spparm alpha; statins.

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Conflict of interest statement

The authors have declared that no competing interests exist.

Figures

Figure 1
Figure 1. Changes in TG (A), HDL-C (B), and LDL-C (C) from before to after pemafibrate treatment.
P-values were calculated using the paired t-test for parametric variables and Wilcoxon signed rank test for non-parametric variables. TG: triglyceride, HDL-C: high-density lipoprotein cholesterol, LDL-C: low-density lipoprotein cholesterol, n.s.: not significant.
Figure 2
Figure 2. Changes in urinary protein (A), eGFR (B), and serum creatinine (C) from before to after pemafibrate treatment.
P-values were calculated using the paired t-test for parametric variables and Wilcoxon signed-rank test for non-parametric variables. eGFR: estimated glomerular filtration rate, n.s.: not significant.
Figure 3
Figure 3. Changes in AST (A), ALT (B), ALP (C), γ-GTP (D), CK (E), and UA (F) from before to after pemafibrate treatment.
P-values were calculated using the paired t-test for parametric variables and Wilcoxon signed-rank test for non-parametric variables. AST: aspartate aminotransferase, ALT: alanine aminotransferase, ALP: alkaline phosphatase, γ-GTP: γ-glutamyl transpeptidase, CK: creatine kinase, UA: uric acid, n.s.: not significant.

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