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Efficacy and Safety of Pemafibrate Versus Fenofibrate in Patients with High Triglyceride and Low HDL Cholesterol Levels: A Multicenter, Placebo-Controlled, Double-Blind, Randomized Trial
Open accessAbstract
AIM: To verify the superiority of pemafibrate over placebo and the non-inferiority of pemafibrate to the maximum dose of fenofibrate for determining the percent change in fasting serum triglyceride (TG) levels and to investigate safety by assessing the incidence of adverse events (AEs) and adverse drug reactions (ADRs). METHODS: This phase III, placebo/active drug-controlled, randomized, double-blind, parallel group comparison study enrolled patients with high TG and low high-density lipoprotein cholesterol levels. Patients were randomly assigned to receive placebo; pemafibrate 0.1 mg/day, 0.2 mg/day, or 0.4 mg/day; or fenofibrate 100 mg/day or 200 mg/day for 12 weeks. RESULTS: Among 526 randomized patients, 489 completed the study, with drop-out rates of 0%, 6.7%, 5.5%, 5.9%, 8.2%, and 10.7% in the placebo; pemafibrate 0.1 mg/day, 0.2 mg/day, and 0.4 mg/day; and fenofibrate 100 mg/day and 200 mg/day groups. The study showed the non-inferiority of pemafibrate 0.4 mg/day and 0.2 mg/day to fenofibrate 200 mg/day as well the non-inferiority and superiority of all pemafibrate doses to fenofibrate 100 mg/day for reducing TG levels. No dose-dependent increase in the incidence of AEs or ADRs was observed among the pemafibrate dose groups. The incidence of AEs and ADRs for all pemafibrate doses was similar to that for placebo and fenofibrate 100 mg/day and significantly lower than that for fenofibrate 200 mg/day (P＜0.05). CONCLUSIONS: The favorable safety profile of pemafibrate, with fewer adverse effects on kidney/liver-related laboratory tests and fewer AEs/ADRs, including those leading to treatment discontinuation, over fenofibrate 200 mg/day may justify the use of this novel and potent treatment option for reducing TG levels in a broader range of patients.
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“When placed in the context of traditional fibrates, pemafibrate’s triglyceride-lowering effects and safety profile appear generally comparable to existing agents.”
From Pemafibrate for hypertriglyceridemia: a meta-analysis of randomized controlled trials evaluating efficacy and safety outcomes (2026) · cites this paper as [24]
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“In head-to-head clinical trials, pemafibrate was observed to reduce triglyceride levels relative to fenofibrate”
From Pemafibrate for hypertriglyceridemia: a meta-analysis of randomized controlled trials evaluating efficacy and safety outcomes (2026) · cites this paper as [24]
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“and showed similar or slightly greater reductions in some comparisons”
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“with a generally lower incidence of hepatic and renal adverse events reported in these studies [23, 24]”
From Pemafibrate for hypertriglyceridemia: a meta-analysis of randomized controlled trials evaluating efficacy and safety outcomes (2026) · cites this paper as [24]
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Metadata
- Authors
- Arai, H., Yamashita, S., Yokote, K., Araki, E., Suganami, H., Ishibashi, S., & on behalf of the K-877 Study Group
- 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
- Journal of Atherosclerosis and Thrombosis
- Publisher
- Japan Atherosclerosis Society
- Published
- 2018-06-01
- Volume
- 25
- Issue
- 6
- Pages
- 521-538
- ISSN
- 1340-3478 (ISSN-L)
- 1880-3873
- PMC
- PMC6005227
- OpenAlex
- W2796005123
- Cited by
- 136
- References
- 26
- Citations by year
- 2026: 8 · 2025: 17 · 2024: 16 · 2023: 21 · 2022: 14 · 2021: 22 · 2020: 9 · 2019: 22 · 2018: 7
- FWCI
- 15.59
- Type
- journal article
- Language
- en
- Open access
- diamond
- doi.org
- Licence
- cc-by-nc-sa
- Locations
- Journal of Atherosclerosis and Thrombosis (publishedVersion, cc-by-nc-sa)
- Europe PMC (PubMed Central) (publishedVersion, cc-by-nc-sa)
- PubMed Central (publishedVersion, cc-by-nc-sa)
- PubMed (publishedVersion)
- Funders
- Kowa Company
- Japan Society for the Promotion of Science (17H04201, 18K08482)
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Lipoproteins and Cardiovascular Health
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Lipid metabolism and disorders
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Peroxisome Proliferator-Activated Receptors
- Keywords
- pemafibrate, fenofibrate, hypertriglyceridemia, low HDL cholesterol, triglyceride lowering, non-inferiority, adverse drug reactions, drug safety, fibrates, dose comparison
- MeSH terms
- Hypolipidemic Agents, Benzoxazoles, Butyrates, Double-Blind Method, Female, Follow-Up Studies, Humans, Cholesterol, HDL, Male, Middle Aged, Fenofibrate, Prognosis, Triglycerides, Hypertriglyceridemia, Biomarkers
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