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Efficacy and safety of K-877, a novel selective peroxisome proliferator-activated receptor α modulator (SPPARMα), in combination with statin treatment: Two randomised, double-blind, placebo-controlled clinical trials in patients with dyslipidaemia
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BACKGROUND AND AIMS: Substantial residual cardiovascular risks remain despite intensive statin treatment. Residual risks with high triglyceride and low high-density lipoprotein cholesterol are not the primary targets of statins. K-877 (pemafibrate) demonstrated robust efficacy on triglycerides and high-density lipoprotein cholesterol and a good safety profile as a monotherapy. The aim of these studies was to evaluate the efficacy and safety of K-877 add-on therapy to treat residual hypertriglyceridaemia during statin treatment. METHODS: The objectives were investigated in two, multicentre, randomised, double-blind, placebo-controlled, parallel group comparison clinical trials: (A) K-877 0.1, 0.2, and 0.4 mg/day in combination with pitavastatin for 12 weeks in 188 patients, (B) K-877 0.2 (fixed dose) and 0.2 (0.4) (conditional up-titration) mg/day in combination with any statin for 24 weeks in 423 patients. RESULTS: In both studies, we found a robust reduction in fasting triglyceride levels by approximately 50% in all combination therapy groups, which was significant compared to the statin-monotherapy (placebo) groups (p < 0.001). High-performance liquid chromatography analysis for lipoprotein subfractions revealed that atherogenic lipoprotein profiles were ameliorated by K-877 add-on therapy, i.e. small low-density lipoproteins decreased whereas larger ones increased, and larger high-density lipoproteins decreased whereas smaller ones increased. The incidence rates of adverse events and adverse drug reactions in K-877 combination therapy groups were comparable to those in statin-monotherapy groups without any noteworthy event in both studies. CONCLUSIONS: These results strongly support the favourable benefit-to-risk ratio of K-877 add-on therapy in combination with statin treatment.
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“Data from Arai 2017, Araki 2018, Araki 2019, Dai 2025, Das 2022, Ginsberg 2022, and Matsuba 2018 showed an RR of 1.02 (95% CI: 0.98, 1.07, p = 0.30), suggesting no significant difference in total adverse events between pemafibrate and placebo (I2 = 0%) (high certainty).”
From Pemafibrate for hypertriglyceridemia: a meta-analysis of randomized controlled trials evaluating efficacy and safety outcomes (2026) · cites this paper as Arai 2017
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Metadata
- Authors
- Arai, H., Yamashita, S., Yokote, K., Araki, E., Suganami, H., & Ishibashi, S.
- Affiliations
- National Center for Geriatrics and Gerontology (JP)
- Rinku General Medical Center (JP)
- Chiba University (JP)
- Kumamoto University (JP)
- Kowa (Japan) (JP)
- Jichi Medical University (JP)
- Corresponding author
- Arai, Hidenori
- Venue
- Atherosclerosis
- Publisher
- Elsevier BV
- Published
- 2017-06
- Volume
- 261
- Pages
- 144-152
- ISSN
- 0021-9150 (ISSN-L)
- OpenAlex
- W2599479486
- Cited by
- 124
- References
- 46
- Citations by year
- 2026: 2 · 2025: 11 · 2024: 11 · 2023: 16 · 2022: 10 · 2021: 13 · 2020: 13 · 2019: 18 · 2018: 16 · 2017: 13
- FWCI
- 16.81
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Atherosclerosis (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- Funders
- Kowa Company
- Astellas Pharma
- Japan Society for the Promotion of Science (17H02100)
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Lipoproteins and Cardiovascular Health
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Peroxisome Proliferator-Activated Receptors
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Lipid metabolism and disorders
- Keywords
- pemafibrate, statin combination therapy, dyslipidemia, triglyceride lowering, HDL cholesterol, atherogenic lipoprotein profile, pitavastatin, adjunctive therapy, drug safety
- MeSH terms
- Adult, Aged, Hypolipidemic Agents, Benzoxazoles, Butyrates, Double-Blind Method, Drug Therapy, Combination, Female, Humans, Japan, Male, Middle Aged, Quinolines, Time Factors, Triglycerides, Hypertriglyceridemia, Signal Transduction, Biomarkers, Treatment Outcome, Hydroxymethylglutaryl-CoA Reductase Inhibitors, PPAR alpha, Young Adult
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