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Clinical Trial
. Jan-Feb 2018;12(1):173-184.
doi: 10.1016/j.jacl.2017.10.006. Epub 2017 Oct 28.

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

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Clinical Trial

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

Shun Ishibashi et al. J Clin Lipidol. .
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Abstract

Background: To overcome the concerns associated with the use of fibrates, pemafibrate (K-877), a novel selective peroxisome proliferator-activated receptor modulator, was developed. In a previous phase 2 trial, we showed excellent efficacy and safety of pemafibrate in patients with dyslipidemia.

Objective: The objective of the study was to evaluate the efficacy and safety of pemafibrate over 24 weeks in adults with dyslipidemia in comparison with fenofibrate.

Methods: In this multicenter, 24-week, double-blind, clinical study, 225 patients with high triglyceride (TG; ≥150 mg/dL [1.7 mmol/L] and <500 mg/dL [5.7 mmol/L]) and relatively low high-density lipoprotein cholesterol (<50 mg/dL [1.3 mmol/L] in men or 55 mg/dL [1.4 mmol/L] in women) levels were randomized to receive either pemafibrate at 0.2 or 0.4 mg/d or fenofibrate 106.6 mg/d.

Results: Pemafibrate 0.2, 0.4 mg/d and fenofibrate significantly reduced TG levels from baseline by -46.2%, -45.9%, and -39.7%, respectively. As compared with fenofibrate, the least squares mean differences (95% confidence intervals) in TG were -6.5% (-12.0, -1.1) and -6.2% (-11.6, -0.8) in pemafibrate 0.2 and 0.4 mg/d respectively, which showed the superiority of these doses of pemafibrate to 106.6 mg/d of fenofibrate. The incidence rates of adverse drug reactions in pemafibrate groups (2.7% and 6.8%) were significantly lower than that in the fenofibrate group (23.7%). Pemafibrate significantly decreased alanine aminotransferase and gamma-glutamyltransferase levels, whereas fenofibrate increased both of them. The increments of serum creatinine and cystatin C were smaller in pemafibrate than those in fenofibrate.

Conclusions: Pemafibrate was superior to fenofibrate in terms of serum TG-lowering effect and hepatic and renal safety.

Keywords: Dyslipidemia; Fatty liver; Fibrates; Homocysteine; K-877; Liver dysfunction; Pemafibrate; Renal dysfunction; Selective PPARα modulator; Triglycerides.

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