한빛사 논문
Yongin Cho1,2†, Hyungjin Rhee3†, Young‑eun Kim4, Minyoung Lee4,5, Byung‑Wan Lee4,5, Eun Seok Kang4,5, Bong‑Soo Cha4,5, Jin‑Young Choi3 and Yong‑ho Lee4,5,6*
1Department of Endocrinology and Metabolism, Inha University School of Medi‑cine, Incheon, Republic of Korea. 2Graduate School, Yonsei University College of Medicine, Seoul, Republic of Korea. 3Department of Radiology, Research Institute of Radiological Science, Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea. 4Department of Internal Medicine, Yonsei University College of Medicine, 50‑1, Yonsei‑ro, Seodaemun‑gu, Seoul 03722, Republic of Korea. 5Institute of Endocrine Research, Yonsei University College of Medicine, Seoul, Republic of Korea. 6Department of Systems Biology, Glyco‑sylation Network Research Center, Yonsei University, Seoul, Republic of Korea.
*Correspondence
†Yongin Cho and Hyungjin Rhee contributed equally to this work.
Abstract
Background
The effect of ezetimibe, Niemann-Pick C1-like 1 inhibitor, on liver fat is not clearly elucidated. Our primary objective was to evaluate the efficacy of ezetimibe plus rosuvastatin versus rosuvastatin monotherapy to reduce liver fat using magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF) in patients with non-alcoholic fatty liver disease (NAFLD).
Methods
A randomized controlled, open-label trial of 70 participants with NAFLD confirmed by ultrasound who were assigned to receive either ezetimibe 10 mg plus rosuvastatin 5 mg daily or rosuvastatin 5 mg for up to 24 weeks. The liver fat change was measured as average values in each of nine liver segments by MRI-PDFF. Magnetic resonance elastography (MRE) was used to measure liver fibrosis change.
Results
Combination therapy significantly reduced liver fat compared with monotherapy by MRI-PDFF (mean difference: 3.2%; p = 0.020). There were significant reductions from baseline to study completion by MRI-PDFF for both the combination and monotherapy groups, respectively (18.1 to 12.3%; p < 0.001 and 15.0 to 12.4%; p = 0.003). Individuals with higher body mass index, type 2 diabetes, insulin resistance, and severe liver fibrosis were likely to be good responders to treatment with ezetimibe. MRE-derived change in liver fibrosis was not significantly different (both groups, p > 0.05). Controlled attenuation parameter (CAP) by transient elastography was significantly reduced in the combination group (321 to 287 dB/m; p = 0.018), but not in the monotherapy group (323 to 311 dB/m; p = 0.104).
Conclusions
Ezetimibe and rosuvastatin were found to be safe to treat participants with NAFLD. Furthermore, ezetimibe combined with rosuvastatin significantly reduced liver fat in this population.
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