Effect of orlistat on liver fat content in patients with nonalcoholic fatty liver disease with obesity: assessment using magnetic resonance imaging-derived proton density fat fraction

Junzhao Ye; Yanqin Wu; Fuxi Li; Tingfeng Wu; Congxiang Shao; Yansong Lin; Wei Wang; Shiting Feng; Bihui Zhong

doi:10.1177/1756284819879047

Effect of orlistat on liver fat content in patients with nonalcoholic fatty liver disease with obesity: assessment using magnetic resonance imaging-derived proton density fat fraction

Therap Adv Gastroenterol. 2019 Sep 26:12:1756284819879047. doi: 10.1177/1756284819879047. eCollection 2019.

Authors

Junzhao Ye¹, Yanqin Wu², Fuxi Li¹, Tingfeng Wu¹, Congxiang Shao¹, Yansong Lin¹, Wei Wang³, Shiting Feng⁴, Bihui Zhong⁵

Affiliations

¹ Department of Gastroenterology, the First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China.
² Department of Interventional Oncology, the First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China.
³ Department of Medical Ultrasonics, the First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China.
⁴ Department of Radiology, the First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China.
⁵ Department of Gastroenterology, the First Affiliated Hospital, Sun Yat-sen University, No. 58 Zhongshan II Road, Yuexiu District, Guangzhou, 510080, China.

Abstract

Background: The liver effect of orlistat as a weight control treatment in patients with nonalcoholic fatty liver disease (NAFLD) with obesity remains undetermined. This study quantified liver fat improvement by orlistat in a Chinese cohort with NAFLD accompanied by obesity, diagnosed by a lower body mass index threshold than that for White patients.

Materials and methods: We conducted a parallel-group, open-label, 24-week, randomized clinical trial registered at the Chinese Clinical Trial Registry (ChiCTR-IPR-17012258). Obese participants with NAFLD were randomized 1:1.5 to the intervention group with orlistat or conventional care. Liver fat quantification was assessed by magnetic resonance imaging-based proton density fat fraction with Dixon sequence.

Results: Overall, 170 (n = 68, orlistat 120 mg three times/day and n = 102, conventional therapy) and 130 patients with NAFLD (n = 56, orlistat and n = 74, conventional therapy) were included for intention-to-treat (ITT) and per-protocol (PP) analysis, respectively. Orlistat reduced liver fat content to a greater degree than conventional care [-5.45% versus -1.96%, p < 0.001 (ITT analysis) and -6.66% versus -2.68%, p < 0.001 (PP analysis)]. The 6-month rate of decrease in steatosis grades was higher in the orlistat group [45.6% versus 22.5% (ITT analysis), 57.4% versus 30.3% (PP analysis), both p < 0.001]. Multivariate logistic regression analysis identified orlistat treatment [odds ratio (OR) = 2.4; 95% confidence interval (CI) 1.1-5.6, p = 0.036] as an independent predictor of steatosis improvement. Among patients with orlistat therapy, weight loss (OR = 1.2, 95% CI 1.1-1.4, p = 0.040) and severe steatosis (OR = 6.7, 95% CI: 1.1-40.3, p = 0.03) remained predictive of steatosis improvement.

Conclusions: Orlistat can effectively promote steatosis improvement and may serve as a treatment option for controlling NAFLD.

Chinese clinical trial registry identifier: ChiCTR-IPR-17012258.

Keywords: magnetic resonance imaging-derived proton density fat fraction; nonalcoholic fatty liver diseases; obesity; orlistat.