AccScience Publishing / BH / Online First / DOI: 10.36922/bh.1629
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REVIEW

Efficacy of pemafibrate in patients with dyslipidemia: A systematic review and meta-analysis of randomized controlled trials

Caroline Cristine Almeida Balieiro1* ,  Maria Esther Barbalho2 ,  Luiza Mendes Fonseca3 ,  Noah Romero Nakajima4 ,  Marcela Mizuhira Gobbo5 ,  Beatriz Polachini Assunes Gonçalves6 ,  Eduardo Cesar Teixeira Sirena7 ,  Alice D. Marinho8 ,  Matheus J. B. Moreira9 ,  Natália Nóbrega de Lima10
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1 Division of Medicine, Amazonas State University, Manaus, Amazonas, Brazil
2 Division of Medicine, University of Potiguar, Natal, Rio Grande do Norte, Brazil
3 Division of Medicine, Faculty of Medical Sciences of Minas Gerais, Belo Horizonte, Minas Gerais, Brazil
4 Division of Medicine, Federal University of Uberlândia, Uberlândia, Minas Gerais, Brazil
5 Division of Medicine, Federal University of Alfenas, Alfenas, Minas Gerais, Brazil
6 Division of Medicine, Federal University of Minas Gerais, Belo Horizonte, Minas Gerais, Brazil
7 Division of Medicine, University of Fortaleza, Fortaleza, Ceará, Brazil
8 Division of Medicine, Federal University of the State of Rio de Janeiro, Rio de Janeiro, Rio de Janeiro, Brazil
9 Division of Medicine, Federal University of Rio Grande do Norte, Natal, Rio Grande do Norte, Brazil
10 Clinics Hospital of Ribeirão Preto, University of São Paulo, Ribeirão Preto, São Paulo, Brazil
Brain & Heart 2023, 1(2), 1629 https://doi.org/10.36922/bh.1629
Submitted: 18 August 2023 | Accepted: 8 November 2023 | Published: 21 November 2023
© 2023 by the Author(s). This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution 4.0 International License ( https://creativecommons.org/licenses/by/4.0/ )
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Abstract

This study aimed to evaluate the efficacy of pemafibrate in patients with hypertriglyceridemia compared to a placebo or fenofibrate through a rigorous systematic review process. To achieve this, we conducted comprehensive searches in the PubMed, Cochrane Library, and Embase databases. The data extraction process was based on published reports, and the assessment of study quality adhered to the PRISMA guidelines. A random-effects model was employed to calculate mean differences (MD) and 95% confidence intervals (CI). Statistical significance was established at P < 0.05, with I² values exceeding 25%, denoting a significant degree of heterogeneity. The primary outcomes of interest were MDs in triglycerides (TG) and non-high-density lipoprotein (HDL) cholesterol. The review protocol was registered with PROSPERO under the identifier CRD42022374852. Nine studies involving 12,644 patients were included, with 6699 (53%) patients receiving pemafibrate. The meta-analysis revealed a significant reduction in serum TG levels in the intervention group (0.4 mg/day) compared to the placebo group (MD: −48.29; 95% CI: −61.45 – −35.13; P < 0.0001; I² = 93%). Pemafibrate (0.4 mg/day) also led to significantly lower non-HDL cholesterol levels compared to control (MD: −6.35; 95% CI: −10.62 – −2.08; P < 0.0001; I² = 82%). There were no significant differences in TG reduction between pemafibrate (0.2 mg/day) and fenofibrate (200 mg/day) (MD: −2.90; 95% CI: −12.90 – 7.11; P = 0.003; I2 = 83%), or between pemafibrate (0.1 mg/day and 0.2 mg/day) and placebo (TG and non-HDL cholesterol levels). In conclusion, pemafibrate demonstrated efficacy in decreasing TG and non-HDL cholesterol levels for dyslipidemia patients, especially at a dosage of 0.4 mg/day compared to a placebo.

Keywords
Dyslipidemia
Pemafibrate
Triglycerides
Meta-analysis
Funding
None.
Conflict of interest
All authors report no relationships that could be construed as a conflict of interest.
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Brain & Heart, Electronic ISSN: 2972-4139 Published by AccScience Publishing
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