Abstract
Background
Pemafibrate is a novel fibrate class drug that is a highly potent and selective agonist of peroxisome proliferator-activated receptor α (PPARα). We performed the first ever network meta-analysis containing the largest ever group of patients to test the efficacy of pemafibrate in improving lipid levels compared with fenofibrate and placebo in patients with dyslipidemia.
Methods
Potentially relevant clinical trials were identified in Medline, PubMed, Embase, clinicaltrials.gov, and Cochrane Controlled Trials registry. Nine randomized controlled trials met the inclusion criteria out of 40 potentially available articles. The primary effect outcome was a change in the levels of triglycerides (TG), high-density lipoproteins (HDL), or low-density lipoproteins (LDL) before and after the treatment.
Results
A total of 12,359 subjects were included. The mean patient age was 54.73 (years), the mean ratio for female patients was 18.75%, and the mean examination period was 14.22 weeks. The dose for pemafibrate included in our study was 0.1, 0.2, or 0.4 mg twice daily, whereas the dose for fenofibrate was 100 mg/day. Data showed a significant reduction in TG and a mild increase in HDL levels across the pemafibrate group at different doses and fenofibrate 100 mg group (with greatest effect observed with pemafibrate 0.1 mg twice daily). A mild increase in LDL was also observed in all groups, but the increase in LDL in the 0.1 mg twice daily dose group was statistically insignificant.
Conclusion
Pemafibrate 0.1 mg twice daily dose led to highest reduction in TG levels and the highest increase in HDL levels compared with other doses of pemafibrate, fenofibrate, and placebo.
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Muhammad Shayan Khan, Ghulam Mujtaba Ghumman, Abdul Baqi, Jay Shah, Muhammad Aziz, Tanveer Mir, Ayesha Tahir, Srinivas Katragadda, Hemindermeet Singh, Mohammed Taleb, and Syed Sohail Ali declare that they have no potential conflicts of interest that might be relevant to the contents of this manuscript.
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The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
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Muhammad Shayan Khan: Conceptualization, software, formal analysis. Ghulam Mujtaba Ghumman: Data curation, writing—original draft. Abdul Baqi: Data curation. Jay Shah: Writing—reviewing and editing. Muhammad Aziz: Methodology, visualization. Tanveer Mir: Software, validation. Ayesha Tahir: Writing—reviewing and editing. Srinivas Katragadda: Resources, project administration. Hemindermeet Singh: Methodology, investigation. Mohammed Taleb and Syed Sohail Ali: Supervision.
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Khan, M.S., Ghumman, G.M., Baqi, A. et al. Efficacy of Pemafibrate Versus Fenofibrate Administration on Serum Lipid Levels in Patients with Dyslipidemia: Network Meta-Analysis and Systematic Review. Am J Cardiovasc Drugs 23, 547–558 (2023). https://doi.org/10.1007/s40256-023-00593-6
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DOI: https://doi.org/10.1007/s40256-023-00593-6