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
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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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Pemafibrate's triglyceride-lowering effects and safety profile appear generally comparable to existing agents (traditional fibrates).
“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]
The Discussion reports that pemafibrate 0.2 and 0.4 mg/day were non-inferior to fenofibrate 200 mg/day for lowering triglycerides, supporting a comparison of efficacy. But it reports fewer adverse events and adverse drug reactions than with fenofibrate 200 mg/day, so describing the safety profiles as generally comparable obscures a distinction the study emphasizes. The comparison is also with fenofibrate, not traditional fibrates as a class. (LLM, conf=0.84)
Experimental — accuracy not yet measuredIn head-to-head clinical trials, pemafibrate reduced triglyceride levels relative to fenofibrate.
“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]
The Results > Efficacy passage reports that all tested pemafibrate doses reduced triglycerides more than fenofibrate 100 mg/day. It found pemafibrate 0.2 and 0.4 mg/day non-inferior, but not superior, to fenofibrate 200 mg/day, so the unqualified comparison overstates the result. (LLM, conf=0.88)
Experimental — accuracy not yet measuredIn head-to-head clinical trials, pemafibrate showed similar or slightly greater reductions in triglyceride levels compared to fenofibrate in some comparisons.
“and showed similar or slightly greater reductions in some comparisons”
From Pemafibrate for hypertriglyceridemia: a meta-analysis of randomized controlled trials evaluating efficacy and safety outcomes (2026) · cites this paper as [24]
In head-to-head clinical trials, pemafibrate had a generally lower incidence of hepatic and renal adverse events compared to fenofibrate.
“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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Interplay between epigenetic mechanisms and transcription factors in atherosclerosis
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Genetics and regulation of HDL metabolism
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Pemafibrate, a novel selective PPARα modulator, attenuates tamoxifen-induced fatty liver disease
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Self-citationIntegrative Multiomics Approaches for Discovery of New Drug Targets for Cardiovascular Disease
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Beyond lipids: fenofibrate in diabetic retinopathy and nephropathy
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Selective activation of PPARα maintains thermogenic capacity of beige adipocytes
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Fibrates: A Possible Treatment Option for Patients with Abdominal Aortic Aneurysm?
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Self-citationNeurological complications of cardiovascular drugs
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Fibrates : Do They Still Have a Role in Therapy in 2025?
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Association between Pemafibrate Therapy and Triglyceride to HDL-Cholesterol Ratio
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Is there still a place for fenofibrate-statin combination therapy?
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Self-citationTreatment of Hypertriglyceridemia: A Review of Therapies in the Pipeline
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- 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 › Surgery › 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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