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Randomized Controlled Trial
. 2023 May 1;30(5):443-454.
doi: 10.5551/jat.63659. Epub 2022 Jun 28.

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

Akihiro Nakamura  1 , Yuta Kagaya  1 , Hiroki Saito  1 , Masanori Kanazawa  1 , Kenjiro Sato  1 , Masanobu Miura  1 , Masateru Kondo  1 , Hideaki Endo  1
Affiliations
Randomized Controlled Trial

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

Akihiro Nakamura et al. J Atheroscler Thromb. .

Erratum in

Abstract

Aim: Pemafibrate is a highly selective agonist for peroxisome proliferator-activated receptor (PPAR)-α, a key regulator of lipid and glucose metabolism. We compared the efficacy and safety of pemafibrate with those of bezafibrate, a nonselective PPAR-α agonist.

Methods: In this randomized crossover study, 60 patients with hypertriglyceridemia (fasting triglyceride [TG] ≥ 150 mg/dL) were treated with pemafibrate of 0.2 mg/day or bezafibrate of 400 mg/day for 24 weeks. The primary endpoint was percent change (%Change) from baseline in TG levels, while the secondary endpoints were %Change in high-density lipoprotein cholesterol (HDL-C) and apolipoprotein A-I (Apo A-I) levels.

Results: The %Change in TG and Apo A-I levels was significantly greater with pemafibrate than with bezafibrate (-46.1% vs. -34.7%, p＜0.001; 9.2% vs. 5.7%, p =0.018, respectively). %Change in HDL-C levels was not significantly different between the two treatments. %Change in liver enzyme levels was markedly decreased with pemafibrate than with bezafibrate. Creatinine levels significantly increased in both treatments; however, its %Change was significantly lower with pemafibrate than with bezafibrate (5.72% vs. 15.5%, p＜0.001). The incidence of adverse events (AEs) or serious AEs did not differ between the two treatments; however, the number of patients with elevated creatinine levels (≥ 0.5 mg/dL and/or 25% from baseline) was significantly higher in the bezafibrate group than in the pemafibrate group (14/60 vs. 3/60, p =0.004) [corrected].

Conclusion: Compared with bezafibrate, pemafibrate is more effective in decreasing TG levels and increasing Apo A-I levels and is safer regarding liver and renal function.

Keywords: Bezafibrate; Comparison of pemafibrate and bezafibrate; Pemafibrate; Peroxisome proliferator-activated receptor (PPAR)-α; Renal function; Triglycerides.

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Conflict of interest statement

The authors declare no conflict of interests.

Figures

Fig.1.
Fig.1.
Flow diagram of patients through each stage of the study
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References

    1. Baigent C, Blackwell L, Emberson J, Holland LE, Reith C, Bhala N, Peto R, Barnes EH, Keech A, Simes J, and Collins R: Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170,000 participants in 26 randomised trials. Lancet, 2010; 376: 1670-1681 - PMC - PubMed
    1. Tall AR, Thomas DG, Conzales-Cabodevilla AG, and Goldberg IJ: Addressing dyslipidemic risk beyond LDL-cholesterol. J Clin Invest, 2022; 132: e148559 - PMC - PubMed
    1. Budoff M: Triglycerides and triglyceride-rich lipoproteins in the causal pathway of cardiovascular disease. Am J Cardiol, 2016; 118: 138-145 - PubMed
    1. Irawati D, Mamo JC, Soares MJ, Slivkoff-Clark KM, and James AP: Hypertriglyceridemic subjects exhibit an accumulation of small dense chylomicron particles in the fasting state. Atherosclerosis, 2015; 243: 236-241 - PubMed
    1. Dallinga-Thie GM, Kroon J, Boren J, and Chapman MJ: Triglyceride-rich lipoproteins and remnants: targets for therapy? Curr Cardiol Rep, 2016; 18: 67 - PMC - PubMed

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