Impact of pemafibrate in patients with metabolic dysfunction‐associated steatotic liver disease complicated by dyslipidemia: A single‐arm prospective study
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
Affiliations
Hiroki Ono
Division of Gastroenterology and Hepatology Nippon Medical School Tokyo Japan
Masanori Atsukawa
Division of Gastroenterology and Hepatology Nippon Medical School Tokyo Japan
Akihito Tsubota
Project Research Units (PRU) Research Center for Medical Science The Jikei University School of Medicine Tokyo Japan
Taeang Arai
Division of Gastroenterology and Hepatology Nippon Medical School Tokyo Japan
Kenta Suzuki
Division of Gastroenterology and Hepatology Nippon Medical School Tokyo Japan
Tetsuyuki Higashi
Division of Gastroenterology and Hepatology Nippon Medical School Tokyo Japan
Michika Kitamura
Division of Gastroenterology and Hepatology Nippon Medical School Tokyo Japan
Kaori Shioda‐Koyano
Division of Gastroenterology and Hepatology Nippon Medical School Tokyo Japan
Tadamichi Kawano
Division of Gastroenterology and Hepatology Nippon Medical School Tokyo Japan
Yuji Yoshida
Division of Gastroenterology Nippon Medical School Chiba Hokusoh Hospital Chiba Japan
Tomomi Okubo
Division of Gastroenterology Nippon Medical School Chiba Hokusoh Hospital Chiba Japan
Korenobu Hayama
Division of Gastroenterology Nippon Medical School Chiba Hokusoh Hospital Chiba Japan
Norio Itokawa
Division of Gastroenterology and Hepatology Nippon Medical School Tokyo Japan
Chisa Kondo
Division of Gastroenterology and Hepatology Nippon Medical School Tokyo Japan
Mototsugu Nagao
Division of Endocrinology, Diabetes and Metabolism Nippon Medical School Tokyo Japan
Masato Iwabu
Division of Endocrinology, Diabetes and Metabolism Nippon Medical School Tokyo Japan
Katsuhiko Iwakiri
Division of Gastroenterology and Hepatology Nippon Medical School Tokyo Japan
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.
