Impact of pemafibrate in patients with metabolic dysfunction-associated steatotic liver disease complicated by dyslipidemia: A single-arm prospective study

IF 1.7 Q3 GASTROENTEROLOGY & HEPATOLOGY JGH Open Pub Date : 2024-04-02 DOI:10.1002/jgh3.13057

Hiroki Ono, Masanori Atsukawa, Akihito Tsubota, Taeang Arai, Kenta Suzuki, Tetsuyuki Higashi, Michika Kitamura, Kaori Shioda-Koyano, Tadamichi Kawano, Yuji Yoshida, Tomomi Okubo, Korenobu Hayama, Norio Itokawa, Chisa Kondo, Mototsugu Nagao, Masato Iwabu, Katsuhiko Iwakiri

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Abstract

Background and Aim

This study aimed to clarify the efficacy and safety of 48-week pemafibrate treatment in patients with metabolic dysfunction-associated steatotic liver disease (MASLD) complicated by dyslipidemia.

Methods

A total of 110 patients diagnosed with MASLD complicated by dyslipidemia received pemafibrate at a dose of 0.1 mg twice daily for 48 weeks.

Results

The participants were 54 males and 37 females, with a median age of 63 (52–71) years. Besides improvement in lipid profile, significant reductions from baseline to 48 weeks of treatment were found in liver-related enzymes, such as aspartate aminotransferase, alanine aminotransferase (ALT), gamma-glutamyl transpeptidase, and alkaline phosphatase (P < 0.001 for all). A significant decrease in the homeostasis model assessment-insulin resistance (HOMA-IR) was observed in patients with insulin resistance (HOMA-IR ≥ 2.5) (4.34 at baseline to 3.89 at Week 48, P < 0.05). Moreover, changes in ALT were weakly correlated with those in HOMA-IR (r = 0.34; p < 0.05). Regarding noninvasive liver fibrosis tests, platelets, Wisteria floribunda agglutinin-positive Mac-2-binding protein, type IV collagen 7s, and the non-alcoholic fatty liver disease fibrosis score significantly decreased from baseline to Week 48. Most adverse events were Grades 1–2, and no drug-related Grade 3 or higher adverse events were observed.

Conclusion

This study demonstrated that 48-week pemafibrate administration improved liver-related enzymes and surrogate marker of liver fibrosis in patients with MASLD. The improvement of insulin resistance by pemafibrate may contribute to the favorable effect on MASLD complicated by dyslipidemia.

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培马贝特对代谢功能障碍相关性脂肪肝并发血脂异常患者的影响：单臂前瞻性研究

背景和目的本研究旨在阐明对代谢功能障碍相关性脂肪性肝病（MASLD）并发血脂异常患者进行48周培马贝特治疗的有效性和安全性。方法共110名确诊为代谢功能障碍并发血脂异常的脂肪肝患者接受培马贝特治疗，剂量为0.1毫克，每天两次，共48周。结果参试者中男性 54 人，女性 37 人，中位年龄为 63（52-71）岁。除了血脂状况有所改善外，从基线到治疗 48 周期间，与肝脏有关的酶，如天门冬氨酸氨基转移酶、丙氨酸氨基转移酶、γ-谷氨酰转肽酶和碱性磷酸酶也有显著下降（均为 0.001）。胰岛素抵抗（HOMA-IR ≥ 2.5）患者的稳态模型评估-胰岛素抵抗（HOMA-IR）明显下降（基线时为 4.34，第 48 周时为 3.89，P < 0.05）。此外，ALT的变化与HOMA-IR的变化呈弱相关性（r = 0.34; P <0.05）。在非侵入性肝纤维化检测方面，血小板、紫藤凝集素阳性 Mac-2 结合蛋白、IV 型胶原 7s 和非酒精性脂肪肝纤维化评分从基线到第 48 周显著下降。大多数不良反应为 1-2 级，未观察到与药物相关的 3 级或以上不良反应。结论本研究表明，服用培马贝特 48 周可改善 MASLD 患者的肝脏相关酶和肝纤维化代用指标。培马贝特对胰岛素抵抗的改善可能是对并发血脂异常的MASLD产生良好疗效的原因之一。

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