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

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.