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Efficacy and Safety of Pemafibrate, a Novel Selective Peroxisome Proliferator-Activated Receptor α Modulator (SPPARMα): Pooled Analysis of Phase 2 and 3 Studies in Dyslipidemic Patients with or without Statin Combination

1
Rinku General Medical Center, Osaka 598-8577, Japan
2
National Center for Geriatrics and Gerontology, Aichi 474-8511, Japan
3
Department of Diabetes, Metabolism and Endocrinology, Chiba University Hospital, Chiba 260-8670, Japan
4
Department of Endocrinology, Hematology and Gerontology, Chiba University Graduate School of Medicine, Chiba 260-8670, Japan
5
Department of Metabolic Medicine, Faculty of Life Sciences, Kumamoto University, Kumamoto 860-8556, Japan
6
Medical Affairs Department, Kowa Company, Ltd., Tokyo 103-8433, 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(22), 5537; https://doi.org/10.3390/ijms20225537
Received: 27 September 2019 / Revised: 1 November 2019 / Accepted: 2 November 2019 / Published: 6 November 2019
(This article belongs to the Special Issue PPARs in Metabolic Regulation: Implications for Health and Disease)
Hypertriglyceridemia has emerged as an independent risk factor for cardiovascular events, despite low-density lipoprotein-cholesterol (LDL-C) well-controlled with statins. We pooled data from the first 12 weeks of six randomized double-blind placebo-controlled studies of pemafibrate in Japan and investigated its efficacy and safety with and without statins, particularly focusing on patients with renal dysfunction. Subjects were 1253 patients (677 in the “with-statin” group and 576 in the “without-statin” group). At Week 12 (last observation carried forward), triglyceride (TG) was significantly reduced at all pemafibrate doses (0.1, 0.2, and 0.4 mg/day), both with and without statin, compared to placebo (p < 0.001 vs. placebo for all groups). In the “with-statin” group, the estimated percent change from baseline was −2.0% for placebo and −45.1%, −48.5%, and −50.0%, respectively, for the pemafibrate groups. Findings for both groups showed significant decreases in TG-rich lipoproteins and atherogenic lipid parameters compared to placebo. The incidence of adverse events was similar between the pemafibrate and placebo groups and was also similar for patients with and without renal dysfunction in the “with-statin” group. Pemafibrate lowered TG and improved atherogenic dyslipidemia without a significant increase in adverse events in comparison to the placebo, even among “with-statin” patients who had renal dysfunction. View Full-Text
Keywords: pemafibrate; triglyceride; selective peroxisome proliferator-activated receptor (PPAR)α modulator; renal dysfunction; lipoprotein subclass; high-performance liquid chromatography (HPLC), concomitant statin pemafibrate; triglyceride; selective peroxisome proliferator-activated receptor (PPAR)α modulator; renal dysfunction; lipoprotein subclass; high-performance liquid chromatography (HPLC), concomitant statin
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MDPI and ACS Style

Yamashita, S.; Arai, H.; Yokote, K.; Araki, E.; Matsushita, M.; Nojima, T.; Suganami, H.; Ishibashi, S. Efficacy and Safety of Pemafibrate, a Novel Selective Peroxisome Proliferator-Activated Receptor α Modulator (SPPARMα): Pooled Analysis of Phase 2 and 3 Studies in Dyslipidemic Patients with or without Statin Combination. Int. J. Mol. Sci. 2019, 20, 5537. https://doi.org/10.3390/ijms20225537

AMA Style

Yamashita S, Arai H, Yokote K, Araki E, Matsushita M, Nojima T, Suganami H, Ishibashi S. Efficacy and Safety of Pemafibrate, a Novel Selective Peroxisome Proliferator-Activated Receptor α Modulator (SPPARMα): Pooled Analysis of Phase 2 and 3 Studies in Dyslipidemic Patients with or without Statin Combination. International Journal of Molecular Sciences. 2019; 20(22):5537. https://doi.org/10.3390/ijms20225537

Chicago/Turabian Style

Yamashita, Shizuya, Hidenori Arai, Koutaro Yokote, Eiichi Araki, Mitsunori Matsushita, Toshiaki Nojima, Hideki Suganami, and Shun Ishibashi. 2019. "Efficacy and Safety of Pemafibrate, a Novel Selective Peroxisome Proliferator-Activated Receptor α Modulator (SPPARMα): Pooled Analysis of Phase 2 and 3 Studies in Dyslipidemic Patients with or without Statin Combination" International Journal of Molecular Sciences 20, no. 22: 5537. https://doi.org/10.3390/ijms20225537

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