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Article

Long-Term Efficacy and Safety of Pemafibrate, a Novel Selective Peroxisome Proliferator-Activated Receptor-α Modulator (SPPARMα), in Dyslipidemic Patients with Renal Impairment

by 1,2,*, 3,4, 5, 6, 7 and 8 on Behalf of the K-877 Study Group
1
Department of Diabetes, Metabolism and Endocrinology, Chiba University Hospital, Chiba 260-8670, Japan
2
Department of Endocrinology, Hematology and Gerontology, Chiba University Graduate School of Medicine, Chiba 260-8670, Japan
3
Department of Community Medicine and Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine, Osaka 565-0871, Japan
4
Rinku General Medical Center, Osaka 598-8577, Japan
5
National Center for Geriatrics and Gerontology, Aichi 474-8511, Japan
6
Department of Metabolic Medicine, Faculty of Life Sciences, Kumamoto University, Kumamoto 860-8556, Japan
7
Clinical Data Science Department, Kowa Company, Ltd., Tokyo 103-8433, Japan
8
Division of Endocrinology and Metabolism, Department of Medicine, Jichi Medical University, Tochigi 329-0498, Japan
*
Author to whom correspondence should be addressed.
Int. J. Mol. Sci. 2019, 20(3), 706; https://doi.org/10.3390/ijms20030706
Received: 9 January 2019 / Revised: 3 February 2019 / Accepted: 3 February 2019 / Published: 6 February 2019
(This article belongs to the Special Issue PPARs in Metabolic Regulation: Implications for Health and Disease)
Pemafibrate (K-877) is a novel selective peroxisome proliferator-activated receptor-α modulator (SPPARMα) with a favorable benefit-risk balance. Previous clinical trials of pemafibrate used stringent exclusion criteria related to renal functions. Therefore, we investigated its safety and efficacy in a broader range of patients, including those with chronic kidney disease (CKD). In this multicenter, single-arm, open-label, phase III trial, 0.2–0.4 mg/day pemafibrate was administered for 52 weeks to 189 patients with hypertriglyceridemia and an estimated glomerular filtration rate (eGFR) ≥ 45 mL/min/1.73 m2 on statin or regardless of eGFR when statin was not administered. Post-hoc analyses were performed on subgroups stratified by baseline eGFR. Triglyceride levels decreased by 45.9% at week 52 (last-observation-carried-forward). These reductions were not correlated with baseline eGFR. The eGFR < 30 mL/min/1.73 m2 subgroup showed the greatest reduction in chylomicron, very low-density lipoprotein, small low-density lipoprotein cholesterol levels, and an increase in high-density lipoprotein cholesterol levels. The incidences of adverse events and adverse drug reactions were 82.0% and 31.7%, respectively, and these were not associated with baseline eGFR. In CKD patients, pemafibrate blood concentrations were not elevated. Pemafibrate showed a good safety profile and efficacy in correcting lipid abnormalities in a broad range of patients, including those with CKD. View Full-Text
Keywords: high-density lipoprotein cholesterol; K-877; pemafibrate; renal dysfunction; safety; selective PPARα modulator; triglyceride high-density lipoprotein cholesterol; K-877; pemafibrate; renal dysfunction; safety; selective PPARα modulator; triglyceride
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MDPI and ACS Style

Yokote, K.; Yamashita, S.; Arai, H.; Araki, E.; Suganami, H.; Ishibashi, S., on Behalf of the K-877 Study Group. Long-Term Efficacy and Safety of Pemafibrate, a Novel Selective Peroxisome Proliferator-Activated Receptor-α Modulator (SPPARMα), in Dyslipidemic Patients with Renal Impairment. Int. J. Mol. Sci. 2019, 20, 706. https://doi.org/10.3390/ijms20030706

AMA Style

Yokote K, Yamashita S, Arai H, Araki E, Suganami H, Ishibashi S on Behalf of the K-877 Study Group. Long-Term Efficacy and Safety of Pemafibrate, a Novel Selective Peroxisome Proliferator-Activated Receptor-α Modulator (SPPARMα), in Dyslipidemic Patients with Renal Impairment. International Journal of Molecular Sciences. 2019; 20(3):706. https://doi.org/10.3390/ijms20030706

Chicago/Turabian Style

Yokote, Koutaro, Shizuya Yamashita, Hidenori Arai, Eiichi Araki, Hideki Suganami, and Shun Ishibashi on Behalf of the K-877 Study Group. 2019. "Long-Term Efficacy and Safety of Pemafibrate, a Novel Selective Peroxisome Proliferator-Activated Receptor-α Modulator (SPPARMα), in Dyslipidemic Patients with Renal Impairment" International Journal of Molecular Sciences 20, no. 3: 706. https://doi.org/10.3390/ijms20030706

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