Efficacy and safety of pemafibrate administration in patients with dyslipidemia: a systematic review and meta-analysis
Open accessAbstract
BACKGROUND: Using a meta-analysis of randomized controlled trials (RCTs), this study aimed to investigate the efficacy and safety of pemafibrate, a novel selective peroxisome proliferator-activated receptor α modulator, in patients with dyslipidemia. METHODS: A search was performed using the MEDLINE, Cochrane Controlled Trials Registry, and ClinicalTrials.gov databases. We decided to employ RCTs to evaluate the effects of pemafibrate on lipid and glucose metabolism-related parameters in patients with dyslipidemia. For statistical analysis, standardized mean difference (SMD) or odds ratio (OR) and 95% confidence intervals (CIs) were calculated using the random effect model. RESULTS: Our search yielded seven RCTs (with a total of 1623 patients) that satisfied the eligibility criteria of this study; hence, those studies were incorporated into this meta-analysis. The triglyceride concentration significantly decreased in the pemafibrate group (SMD, - 1.38; 95% CI, - 1.63 to - 1.12; P < 0.001) than in the placebo group, with a reduction effect similar to that exhibited by fenofibrate. Compared with the placebo group, the pemafibrate group also showed improvements in high-density and non-high-density lipoprotein cholesterol levels as well as in homeostasis model assessment for insulin resistance. Furthermore, the pemafibrate group showed a significant decrease in hepatobiliary enzyme activity compared with the placebo and fenofibrate groups; and, total adverse events (AEs) were significantly lower in the pemafibrate group than in the fenofibrate group (OR, 0.60; 95% CI, 0.49-0.73; P < 0.001). In contrast, the low-density lipoprotein cholesterol level was significantly higher in the pemafibrate group than in the placebo (P = 0.006) and fenofibrate (P < 0.001) groups. CONCLUSIONS: The lipid profile significantly improved in the pemafibrate group than in the placebo group. In addition to the pemafibrate group having an improved lipid profile, which was comparable with that of the fenofibrate group, the AEs were significantly lower than in the fenofibrate group and an improvement in hepatobiliary enzyme activity was also recognized. However, we believe that actual clinical data as well as long-term efficacy and safety need to be investigated in the future.
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Previous meta-analyses reported high heterogeneity (I2 = 86%) when assessing the 0.2 mg dose.
“Previous meta-analyses reported high heterogeneity (I2 = 86%) when assessing the 0.2 mg dose, raising uncertainty about the consistency of its efficacy.”
From Pemafibrate for hypertriglyceridemia: a meta-analysis of randomized controlled trials evaluating efficacy and safety outcomes (2026) · cites this paper as [7]
The Results > Efficacy section reports high heterogeneity (I² = 78%) for the pooled triglyceride analysis across pemafibrate doses. Our copy does not report I² = 86% for the 0.2 mg dose, so the dose-specific figure is unsupported. (LLM, conf=0.86)
Experimental — accuracy not yet measuredPemafibrate'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 [26]
The Results and Conclusions report triglyceride-lowering effects comparable to fenofibrate. They do not characterize the safety profiles as merely comparable: total adverse events were significantly fewer with pemafibrate, and hepatobiliary enzyme findings were more favorable. The direct comparison is with fenofibrate, not traditional fibrates generally. (LLM, conf=0.88)
Experimental — accuracy not yet measuredClinical trials have demonstrated significant triglyceride-lowering effects of pemafibrate across different dosing regimens.
“Clinical trials have evaluated pemafibrate in diverse patient populations with dyslipidemia, demonstrating significant TG-lowering effects across different dosing regimens [5–7].”
From Pemafibrate for hypertriglyceridemia: a meta-analysis of randomized controlled trials evaluating efficacy and safety outcomes (2026) · cites this paper as [7]
Meta-analytic evidence suggests that pemafibrate's lipid-modifying effects, including reductions in triglycerides and modest improvements in HDL-C, are broadly comparable to those seen with conventional fibrates.
“Meta-analytic evidence also suggests that pemafibrate’s lipid-modifying effects, including reductions in triglycerides and modest improvements in HDL-C, are broadly comparable to those seen with conventional fibrates, although the certainty of evidence varies and long-term clinical implications remain uncertain [25, 26].”
From Pemafibrate for hypertriglyceridemia: a meta-analysis of randomized controlled trials evaluating efficacy and safety outcomes (2026) · cites this paper as [26]
Evidence comparing 0.2 mg versus 0.4 mg pemafibrate dosing has produced conflicting results.
“Furthermore, evidence comparing 0.2 mg versus 0.4 mg dosing has produced conflicting results, leaving clinicians uncertain about optimal dose selection.”
From Pemafibrate for hypertriglyceridemia: a meta-analysis of randomized controlled trials evaluating efficacy and safety outcomes (2026) · cites this paper as [7]
The Discussion mentions 0.2 and 0.4 mg/day as the highest doses and suggests a dose-dependent ALT effect. The Results compare pemafibrate with placebo or fenofibrate, but the passages found do not report conflicting results from a comparison of 0.2 mg versus 0.4 mg or uncertainty about which dose to select (searched: dose comparison and dose-dependent effects). (LLM, conf=0.73)
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A review on the efficacy and safety of lipid-lowering drugs in neurodegenerative disease
Rajabian, A., McCloskey, A. P., Jamialahmadi, T., Moallem, S. A., & Sahebkar, A. (2023) · Reviews in the Neurosciences · doi:10.1515/revneuro-2023-0005 · Cited by 7 · see citing works
Anti-GPIHBP1 Antibody-Positive Autoimmune Hyperchylomicronemia and Immune Thrombocytopenia
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“…suggests that pemafi-brate’s lipid-modifying effects, including reductions in triglycerides and modest improvements in HDL-C, are broadly comparable to those seen with conventional fibrates, although the certainty of evidence varies and long-term clinical implications remain uncertain [25, 26].”
Emerging New Lipid-Lowering Therapies in the Statin Era
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- Authors
- Ida, S., Kaneko, R., & Murata, K.
- Affiliations
- Ise Red Cross Hospital (JP)
- Corresponding author
- Ida, Satoshi
- Venue
- Cardiovascular Diabetology
- Published
- 2019-03-21
- Volume
- 18
- Issue
- 1
- Pages
- 38-38
- ISSN
- 1475-2840 (ISSN-L)
- PMC
- PMC6429757
- OpenAlex
- W2924575318
- Cited by
- 61
- References
- 39
- Citations by year
- 2026: 1 · 2025: 3 · 2024: 7 · 2023: 12 · 2022: 9 · 2021: 10 · 2020: 15 · 2019: 4
- FWCI
- 0.86
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Cardiovascular Diabetology (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
- Topics
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Peroxisome Proliferator-Activated Receptors
- Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Lipid metabolism and disorders
- Keywords
- pemafibrate, dyslipidemia, PPARα modulator, fenofibrate, triglycerides, LDL cholesterol, HDL cholesterol, insulin resistance, hepatobiliary enzymes, adverse events, lipid profile, drug safety, drug efficacy, hypertriglyceridemia, hypercholesterolemia, hepatic steatosis
- MeSH terms
- Hypolipidemic Agents, Benzoxazoles, Biliary Tract, Butyrates, Female, Humans, Lipids, Liver, Male, Middle Aged, Biomarkers, Treatment Outcome, PPAR alpha, Dyslipidemias
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