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Review
. 2025 Apr 22;87(6):3756-3767.
doi: 10.1097/MS9.0000000000003264. eCollection 2025 Jun.

Efficacy and safety of pemafibrate administration in patients with dyslipidemia: a systematic review and updated meta-analysis of randomized controlled trials

Mohammed A Elbahloul  1 , Ammar Elgadi  2 , Mohamed Ramadan  3 , Houssaini Mohamed Amine  4 , Hossam Fayed  5 , Mohamed E Kasser  1 , Ahmed Hussein  6 , Fatma Labieb  7
Affiliations
Review

Efficacy and safety of pemafibrate administration in patients with dyslipidemia: a systematic review and updated meta-analysis of randomized controlled trials

Mohammed A Elbahloul et al. Ann Med Surg (Lond). .

Abstract

Background: Patients with dyslipidemia are at risk for cardiovascular diseases. Lowering levels of lipid decrease morbidity. Pemafibrate is a selective peroxisome proliferator-activated receptor α modulator (SPPARMα) that works better at lowering serum triglycerides.

Methods: Clinical trials investigating the effect of pemafibrate on lipid biomarkers in patients with dyslipidemia were searched in PubMed, Ovid Medline, SCOPUS, Web of Science (WOS), and the Cochrane Library from inception till 31 December 2023. The data were pooled as mean difference, odds ratio (OR), and 95% confidence interval (CI).

Results: 14 clinical trials were eligible, involving 12 451 patients, and showed favorable triglyceride level change (MD: -49.60 [-62.64, -36.55] P < 0.00001) for pemafibrate compared to placebo. Pemafibrate showed a significant increase in HDL-C levels (MD: 14.57 [10.14, 19.01] P < 0.00001) but showed a concurrent increase in LDL-C levels (MD: 10.99 [6.10, 15.88] P < 0.00001). It also showed non-HDL-C, total cholesterol level, Apo B, Apo C-II, and Apo C-III to be significantly reduced in pemafibrate groups. Also, in pemafibrate groups, hepatic adverse events were reported less frequently than in placebo groups. No significant difference was found in the frequency of total adverse effects, adverse drug reactions, or serious adverse events between the pemafibrate and placebo groups.

Conclusion: Pemafibrate improved the overall lipid biomarkers compared to placebo groups, demonstrating a significant reduction in triglycerides, non-HDL-C, and total cholesterol while increasing HDL-C. Moreover, there was no significant difference in adverse effects.

Keywords: adverse events; dyslipidemia; lipid biomarkers; other fibrates; pemafibrate.

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Conflict of interest statement

Sponsorships or competing interests that may be relevant to content are disclosed at the end of this article. All authors have no disclosures or conflict of interests.

Figures

Figure 1.
Figure 1.
PRISMA flowchart.
Figure 2.
Figure 2.
Risk of bias according to cochrane risk of bias tool (version 2).
Figure 3.
Figure 3.
Forest plot presenting MD for the effect of pemafibrate VS placebo on TGs.
Figure 4.
Figure 4.
Forest plot presenting MD for the effect of pemafibrate VS other fibrates on TGs.
Figure 5.
Figure 5.
Forest plot presenting OR for effect of pemafibrate VS placebo on total AEs.
Figure 6.
Figure 6.
Forest plot presenting OR for effect of pemafibrate VS other fibrates on total AEs.
See this image and copyright information in PMC

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