A Double-Blind Randomized Placebo-Controlled Trial of Orlistat for the Treatment of Nonalcoholic Fatty Liver Disease

Impact of current treatments on liver disease, glucose metabolism and cardiovascular risk in non-alcoholic fatty liver disease (NAFLD): a systematic review and meta-analysis of randomised trials

“…Two RCTs also showed an improvement in plasma adiponectin [8,12]. Among drugs inducing weight loss, orlistat was safe, well-tolerated with minor adverse gastrointestinal complaints not requiring discontinuation of therapy, but conferred no additional cardio-metabolic or histological benefit over lifestyle intervention alone [7,12]. There was no significant publication bias for assessed outcomes (not reported).…”

“…Eight RCTs (373 participants, 39% diabetic; six RCTs with a low risk of bias, four RCTs with post-treatment histology) assessed the effect of lifestyle-or drug-induced weight loss in NAFLD [6][7][8][9][10][11][12][13] (ESM Table 1). …”

The diagnosis and management of non-alcoholic fatty liver disease: Practice Guideline by the American Association for the Study of Liver Diseases, American College of Gastroenterology, and the American Gastroenterological Association

“…[96][97][98] Orlistat (an enteric lipase inhibitor) in conjunction with lifestyle modification was investigated in two randomized controlled trials. In the study by ZieglerSagi et al, 99 orlistat reportedly improved ALT and steatosis by US, but its effect on liver histology could not be evaluated because the majority of patients did not undergo a follow-up liver biopsy. However, in the study by Harrison et al, 100 orlistat did not improve body weight or liver histology.…”

EASL–EASD–EASO Clinical Practice Guidelines for the management of non-alcoholic fatty liver disease

“…Available data on pentoxifylline and orlistat are limited or inconclusive [86,91,97]. Also, data on lipidlowering drugs are poor; recent trials with ezetimibe were negative [101,103], whereas statins have not been adequately tested.…”