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Brain & Heart

REVIEW ARTICLE
Efficacy of pemafibrate in patients with

dyslipidemia: A systematic review and
meta-analysis of randomized controlled trials

2
1
Caroline Cristine Almeida Balieiro *, Maria Esther Barbalho ,
3
Luiza Mendes Fonseca , Noah Romero Nakajima , Marcela Mizuhira Gobbo ,
5
4
Beatriz Polachini Assunes Gonçalves , Eduardo Cesar Teixeira Sirena ,
7
6
Alice D. Marinho , Matheus J. B. Moreira , and Natália Nóbrega de Lima 10
8
9
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

Abstract

This study aimed to evaluate the efficacy of pemafibrate in patients with
hypertriglyceridemia compared to a placebo or fenofibrate through a rigorous
*Corresponding author:
Caroline Cristine Almeida Balieiro systematic review process. To achieve this, we conducted comprehensive searches in
(carolinecbalieiro@gmail.com) the PubMed, Cochrane Library, and Embase databases. The data extraction process
was based on published reports, and the assessment of study quality adhered to
Citation: Balieiro CCA, Barbalho ME,
Fonseca LM, et al., 2023, Efficacy the PRISMA guidelines. A random-effects model was employed to calculate mean
of pemafibrate in patients with differences (MD) and 95% confidence intervals (CI). Statistical significance was
dyslipidemia: A systematic review and established at P < 0.05, with I² values exceeding 25%, denoting a significant degree of
meta-analysis of randomized controlled
trials. Brain & Heart, 1(2): 1629. heterogeneity. The primary outcomes of interest were MDs in triglycerides (TG) and
https://doi.org/10.36922/bh.1629 non-high-density lipoprotein (HDL) cholesterol. The review protocol was registered
Received: August 18, 2023 with PROSPERO under the identifier CRD42022374852. Nine studies involving
12,644 patients were included, with 6699 (53%) patients receiving pemafibrate. The
Accepted: November 8, 2023
meta-analysis revealed a significant reduction in serum TG levels in the intervention
Published Online: November 21, group (0.4 mg/day) compared to the placebo group (MD: −48.29; 95% CI: −61.45
2023 – −35.13; P < 0.0001; I² = 93%). Pemafibrate (0.4 mg/day) also led to significantly
Copyright: © 2023 Author(s). lower non-HDL cholesterol levels compared to control (MD: −6.35; 95% CI: −10.62
This is an Open Access article – −2.08; P < 0.0001; I² = 82%). There were no significant differences in TG reduction
distributed under the terms of the
Creative Commons Attribution between pemafibrate (0.2 mg/day) and fenofibrate (200 mg/day) (MD: −2.90; 95% CI:
2
License, permitting distribution, −12.90 – 7.11; P = 0.003; I = 83%), or between pemafibrate (0.1 mg/day and 0.2 mg/
and reproduction in any medium, day) and placebo (TG and non-HDL cholesterol levels). In conclusion, pemafibrate
provided the original work is
properly cited. 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.
Publisher’s Note: AccScience
Publishing remains neutral with
regard to jurisdictional claims in
published maps and institutional Keywords: Dyslipidemia; Pemafibrate; Triglycerides; Meta-analysis
affiliations.

Volume 1 Issue 2 (2023) 1 https://doi.org/10.36922/bh.1629