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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

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 inv...

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Autores principales: Yamashita, Shizuya, Arai, Hidenori, Yokote, Koutaro, Araki, Eiichi, Matsushita, Mitsunori, Nojima, Toshiaki, Suganami, Hideki, Ishibashi, Shun
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6888510/
https://www.ncbi.nlm.nih.gov/pubmed/31698825
http://dx.doi.org/10.3390/ijms20225537
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author Yamashita, Shizuya
Arai, Hidenori
Yokote, Koutaro
Araki, Eiichi
Matsushita, Mitsunori
Nojima, Toshiaki
Suganami, Hideki
Ishibashi, Shun
author_facet Yamashita, Shizuya
Arai, Hidenori
Yokote, Koutaro
Araki, Eiichi
Matsushita, Mitsunori
Nojima, Toshiaki
Suganami, Hideki
Ishibashi, Shun
author_sort Yamashita, Shizuya
collection PubMed
description 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.
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spelling pubmed-68885102019-12-09 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 Yamashita, Shizuya Arai, Hidenori Yokote, Koutaro Araki, Eiichi Matsushita, Mitsunori Nojima, Toshiaki Suganami, Hideki Ishibashi, Shun Int J Mol Sci Article 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. MDPI 2019-11-06 /pmc/articles/PMC6888510/ /pubmed/31698825 http://dx.doi.org/10.3390/ijms20225537 Text en © 2019 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Yamashita, Shizuya
Arai, Hidenori
Yokote, Koutaro
Araki, Eiichi
Matsushita, Mitsunori
Nojima, Toshiaki
Suganami, Hideki
Ishibashi, Shun
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
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6888510/
https://www.ncbi.nlm.nih.gov/pubmed/31698825
http://dx.doi.org/10.3390/ijms20225537
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