A double-blind randomized placebo-controlled trial of orlistat for the treatment of nonalcoholic fatty liver disease
Open accessAbstract
Background & aims Few controlled studies have addressed the issue of effective medical treatment for nonalcoholic fatty liver disease (NAFLD). We herein assessed the effect of orlistat in patients with NAFLD. Methods We performed a randomized, double-blind, placebo-controlled study on 52 patients with NAFLD diagnosed by ultrasound (US) and confirmed by liver biopsy (40 patients). The patients were randomized to receive either orlistat (120 mg 3 times daily for 6 months) or placebo. All patients participated in an identical behavioral weight loss program. All patients underwent monthly evaluation by abdominal US; liver enzyme levels, lipid profiles, insulin levels, and anthropometric parameters were monitored, and all patients underwent nutritional follow-up evaluation. Twenty-two patients underwent a second liver biopsy examination at the end of the study. Results Fifty-two patients were recruited and 44 (mean age, 47.7 y; mean body mass index, 33) completed the study. Serum glucose and insulin levels (P<.03) were significantly higher in the orlistat group, which also presented a higher degree of fibrosis. Body mass index was reduced significantly in each group, with a nonsignificant difference between the groups. Serum alanine transaminase (ALT) levels decreased significantly in both groups, with an almost 2-fold reduction in the orlistat group (48% vs 26.4%). There was a statistically significant reversal of fatty liver by US only in the orlistat group (P<.05). Conclusions Orlistat improves serum ALT levels and steatosis on US in NAFLD patients, beyond its effect on weight reduction.
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In patients with NAFLD, 24 weeks of orlistat plus lifestyle did not change fibrosis.
“| Zelber-Sagi et al. | Orlistat + lifestyle vs. | NAFLD | Steatosis ↔; fibrosis ↔ | ↔ | NR | ↔ | NR |”
From Obesity and MASLD: Is weight loss the (only) key to treat metabolic liver disease? (2024) · cites this paper as [95]
In patients with NAFLD, 24 weeks of orlistat plus lifestyle did not change body weight.
“| Zelber-Sagi et al. | Orlistat + lifestyle vs. | NAFLD | Steatosis ↔; fibrosis ↔ | ↔ | NR | ↔ | NR |”
From Obesity and MASLD: Is weight loss the (only) key to treat metabolic liver disease? (2024) · cites this paper as [95]
In patients with NAFLD, 24 weeks of orlistat plus lifestyle did not change steatosis.
“| Zelber-Sagi et al. | Orlistat + lifestyle vs. | NAFLD | Steatosis ↔; fibrosis ↔ | ↔ | NR | ↔ | NR |”
From Obesity and MASLD: Is weight loss the (only) key to treat metabolic liver disease? (2024) · cites this paper as [95]
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- Authors
- Zelber–Sagi, S., Kessler, A., Brazowsky, E., Webb, M., Lurie, Y., Santo, M., Leshno, M., Blendis, L., Halpern, Z., & Oren, R.
- Affiliations
- Tel Aviv University (IL)
- Corresponding author
- Oren, Ran
- Venue
- Clinical Gastroenterology and Hepatology
- Publisher
- Elsevier BV
- Published
- 2006-05
- Volume
- 4
- Issue
- 5
- Pages
- 639-644
- ISSN
- 1542-3565 (ISSN-L)
- OpenAlex
- W2154075360
- Cited by
- 317
- References
- 0
- Citations by year
- 2026: 8 · 2025: 6 · 2024: 9 · 2023: 5 · 2022: 9 · 2021: 17 · 2020: 12 · 2019: 22 · 2018: 17 · 2017: 19 · 2016: 19 · 2015: 21 · 2014: 21 · 2013: 12 · 2012: 14
- FWCI
- 18.87
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Clinical Gastroenterology and Hepatology (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Epidemiology › Liver Disease Diagnosis and Treatment
- Health Sciences › Medicine › Pharmacology › Pharmacology and Obesity Treatment
- Health Sciences › Medicine › Surgery › Bariatric Surgery and Outcomes
- Keywords
- orlistat, non-alcoholic fatty liver disease, weight loss, steatosis, liver fibrosis, alanine aminotransferase, insulin resistance, hyperglycemia, lipid profile
- MeSH terms
- Orlistat, Adolescent, Adult, Aged, Biopsy, Needle, Dose-Response Relationship, Drug, Double-Blind Method, Drug Administration Schedule, Fatty Liver, Female, Follow-Up Studies, Humans, Immunohistochemistry, Lactones, Liver Function Tests, Male, Middle Aged, Probability, Reference Values, Severity of Illness Index, Weight Loss, Body Mass Index, Treatment Outcome, Risk Assessment, Ultrasonography, Doppler, Anti-Obesity Agents
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