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佩马贝特治疗血脂异常患者的疗效和安全性:一项随机对照试验的系统评价和更新的荟萃分析

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

作者信息

Elbahloul Mohammed A, Elgadi Ammar, Ramadan Mohamed, Mohamed Amine Houssaini, Fayed Hossam, Kasser Mohamed E, Hussein Ahmed, Labieb Fatma

机构信息

Faculty of Medicine, Kafr El-Shaikh University, Kafr El Sheikh, Egypt.

Faculty of Medicine, University of Khartoum, Khartoum, Sudan.

出版信息

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


DOI:10.1097/MS9.0000000000003264
PMID:40486565
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12140688/
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]  < 0.00001) for pemafibrate compared to placebo. Pemafibrate showed a significant increase in HDL-C levels (MD: 14.57 [10.14, 19.01]  < 0.00001) but showed a concurrent increase in LDL-C levels (MD: 10.99 [6.10, 15.88]  < 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.

摘要

背景:血脂异常患者有患心血管疾病的风险。降低血脂水平可降低发病率。培马贝特是一种选择性过氧化物酶体增殖物激活受体α调节剂(SPPARMα),在降低血清甘油三酯方面效果更佳。 方法:在PubMed、Ovid Medline、SCOPUS、科学网(WOS)和Cochrane图书馆中检索从创刊至2023年12月31日期间研究培马贝特对血脂异常患者脂质生物标志物影响的临床试验。数据合并为平均差、比值比(OR)和95%置信区间(CI)。 结果:14项临床试验符合条件,涉及12451名患者,与安慰剂相比,培马贝特显示出有利的甘油三酯水平变化(平均差:-49.60 [-62.64, -36.55] <0.00001)。培马贝特显示高密度脂蛋白胆固醇(HDL-C)水平显著升高(平均差:14.57 [10.14, 19.01] <0.00001),但低密度脂蛋白胆固醇(LDL-C)水平同时升高(平均差:10.99 [6.10, 15.88] <0.00001)。培马贝特组的非高密度脂蛋白胆固醇、总胆固醇水平、载脂蛋白B、载脂蛋白C-II和载脂蛋白C-III也显著降低。此外,在培马贝特组中,肝脏不良事件的报告频率低于安慰剂组。培马贝特组与安慰剂组在总不良反应、药物不良反应或严重不良事件的频率上未发现显著差异。 结论:与安慰剂组相比,培马贝特改善了整体脂质生物标志物,显示甘油三酯、非高密度脂蛋白胆固醇和总胆固醇显著降低,同时高密度脂蛋白胆固醇升高。此外,不良反应无显著差异。

相似文献

[1]
Efficacy and safety of pemafibrate administration in patients with dyslipidemia: a systematic review and updated meta-analysis of randomized controlled trials.

Ann Med Surg (Lond). 2025-4-22

[2]
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Curr Atheroscler Rep. 2020-1-23

[3]
Triglyceride Lowering with Pemafibrate to Reduce Cardiovascular Risk.

N Engl J Med. 2022-11-24

[4]
Efficacy and safety of pemafibrate administration in patients with dyslipidemia: a systematic review and meta-analysis.

Cardiovasc Diabetol. 2019-3-21

[5]
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[6]
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Intern Med. 2021-9-1

[7]
Efficacy and safety of pemafibrate (K-877), a selective peroxisome proliferator-activated receptor α modulator, in patients with dyslipidemia: Results from a 24-week, randomized, double blind, active-controlled, phase 3 trial.

J Clin Lipidol. 2017-10-28

[8]
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[9]
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Am J Cardiovasc Drugs. 2023-9

[10]
Effects of pemafibrate on glucose metabolism markers and liver function tests in patients with hypertriglyceridemia: a pooled analysis of six phase 2 and phase 3 randomized double-blind placebo-controlled clinical trials.

Cardiovasc Diabetol. 2021-5-4

本文引用的文献

[1]
Low-Density Lipoprotein Cholesterol, Cardiovascular Disease Risk, and Mortality in China.

JAMA Netw Open. 2024-7-1

[2]
Clinical Efficacy and Safety of Low-Dose Pemafibrate in Patients With Severe Renal Impairment: A Retrospective Study.

Cureus. 2024-4-7

[3]
Non-HDL-cholesterol in dyslipidemia: Review of the state-of-the-art literature and outlook.

Atherosclerosis. 2023-10

[4]
Association of PCSK9 Inhibitor Initiation on Statin Adherence and Discontinuation.

J Am Heart Assoc. 2023-9-19

[5]
Using Risk of Bias 2 to assess results from randomised controlled trials: guidance from Cochrane.

BMJ Evid Based Med. 2023-8

[6]
Dyslipidemia and Cardiovascular Disease: Current Knowledge, Existing Challenges, and New Opportunities for Management Strategies.

J Clin Med. 2023-1-3

[7]
Triglyceride Lowering with Pemafibrate to Reduce Cardiovascular Risk.

N Engl J Med. 2022-11-24

[8]
Efficacy and Safety of Pemafibrate Versus Bezafibrate to Treat Patients with Hypertriglyceridemia: A Randomized Crossover Study.

J Atheroscler Thromb. 2023-5-1

[9]
Association between Pemafibrate Therapy and Triglyceride to HDL-Cholesterol Ratio.

J Clin Med. 2022-5-17

[10]
Inflammatory Links Between Hypertriglyceridemia and Atherogenesis.

Curr Atheroscler Rep. 2022-5

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