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Ezetimibe combination therapy with statin for non-alcoholic fatty liver disease: an open-label randomized controlled trial (ESSENTIAL study)

Authors
 Yongin Cho  ;  Hyungjin Rhee  ;  Young-Eun Kim  ;  Minyoung Lee  ;  Byung-Wan Lee  ;  Eun Seok Kang  ;  Bong-Soo Cha  ;  Jin-Young Choi  ;  Yong-Ho Lee 
Citation
 BMC MEDICINE, Vol.20(1) : 93, 2022-03 
Journal Title
BMC MEDICINE
Issue Date
2022-03
MeSH
Diabetes Mellitus, Type 2* ; Elasticity Imaging Techniques* ; Ezetimibe / therapeutic use ; Humans ; Hydroxymethylglutaryl-CoA Reductase Inhibitors* ; Non-alcoholic Fatty Liver Disease* / diagnostic imaging ; Non-alcoholic Fatty Liver Disease* / drug therapy ; Non-alcoholic Fatty Liver Disease* / pathology
Keywords
Hepatic fibrosis ; Hepatic steatosis ; Niemann-Pick C1-like 1 inhibitor ; Statins
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.

Trial registration: The trial was registered at ClinicalTrials.gov (registration number: NCT03434613 ).
Files in This Item:
T202201731.pdf Download
DOI
10.1186/s12916-022-02288-2
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Radiology (영상의학교실) > 1. Journal Papers
Yonsei Authors
Kang, Eun Seok(강은석) ORCID logo https://orcid.org/0000-0002-0364-4675
Kim, Young-Eun(김영은)
Lee, Minyoung(이민영) ORCID logo https://orcid.org/0000-0002-9333-7512
Lee, Byung Wan(이병완) ORCID logo https://orcid.org/0000-0002-9899-4992
Lee, Yong Ho(이용호) ORCID logo https://orcid.org/0000-0002-6219-4942
Rhee, Hyungjin(이형진) ORCID logo https://orcid.org/0000-0001-7759-4458
Cho, Yong In(조용인) ORCID logo https://orcid.org/0000-0002-4645-816X
Cha, Bong Soo(차봉수) ORCID logo https://orcid.org/0000-0003-0542-2854
Choi, Jin Young(최진영) ORCID logo https://orcid.org/0000-0002-9025-6274
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/188760
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