The DOI matches its Crossref record; 46 of the 46 references it cites were found in a registry or an index.
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
Open accessAbstract
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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Inflammation, Atherosclerosis, and Coronary Artery Disease
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2016 ESC/EAS Guidelines for the Management of Dyslipidaemias
Catapano, A. L., Graham, I., De Backer, G., Wiklund, O., Chapman, M. J., Drexel, H., Hoes, A. W., Jennings, C. S., Landmesser, U., Pedersen, T. R., et al. (2016) · Atherosclerosis · doi:10.1016/j.atherosclerosis.2016.08.018 · Cited by 1,582
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Molecular Actions of PPARα in Lipid Metabolism and Inflammation
Bougarne, N., Weyers, B., Desmet, S. J., Deckers, J., Ray, D. W., Staels, B., & De Bosscher, K. (2018) · Endocrine Reviews · doi:10.1210/er.2018-00064 · Cited by 898
Triglyceride Lowering with Pemafibrate to Reduce Cardiovascular Risk
Das Pradhan, A., Glynn, R. J., Fruchart, J.-C., MacFadyen, J. G., Zaharris, E. S., Everett, B. M., Campbell, S. E., Oshima, R., Amarenco, P., Blom, D. J., et al. (2022) · New England Journal of Medicine · doi:10.1056/nejmoa2210645 · Cited by 749
Self-citationDuran, E. K., Aday, A. W., Cook, N. R., Buring, J. E., Ridker, P. M., & Pradhan, A. D. (2020) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2020.02.059 · Cited by 347
Pradhan, A. D., Paynter, N. P., Everett, B. M., Glynn, R. J., Amarenco, P., Elam, M., Ginsberg, H., Hiatt, W. R., Ishibashi, S., Koenig, W., et al. (2018) · American Heart Journal · doi:10.1016/j.ahj.2018.09.011 · Cited by 319
Self-citationPPAR Agonists and Metabolic Syndrome: An Established Role?
Botta, M., Audano, M., Sahebkar, A., Sirtori, C. R., Mitro, N., & Ruscica, M. (2018) · International Journal of Molecular Sciences · doi:10.3390/ijms19041197 · Cited by 260
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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