Orlistat Associated with Weight Loss, No Liver Complications

In a recent retrospective study, the weight loss agent orlistat was not shown to have hepatotoxic effects (as measured by liver function testing), contrary to current warnings. It was also associated with a significant decrease in body mass index (BMI) in obese patients when compared with patients who did not receive the drug.

Rajeev Sharma, MD, at the State University of New York Downstate Medical Center and colleagues reported their findings at ENDO 2013: The Endocrine Society’s 95^th Annual Meeting and Expo in San Francisco on June 15, 2013.

According to the authors, current management strategies for obesity include lifestyle changes, behavioral therapy, and pharmacological options, including orlistat. However, in 2010 the FDA approved a revised label to include information about severe liver injury associated with its use, based on clinical case reports. Citing a paucity of large studies to demonstrate an association between orlistat and hepatic dysfunction, the authors aimed to evaluate hepatic effects, as well as weight-loss effects, of Orlistat on obese patients at the Brooklyn VA Hospital.Seventy-two patients were enrolled in this retrospective, case control study from 2006 to 2012. The patients were enrolled in the Managing Overweight/Obesity in Veterans Everywhere (MOVE) program at the Brooklyn, New York VA clinic. Hepatotoxic drugs were not permitted, with the exception of HMG-CoA reductase inhibitors (statins).

Thirty-six patients received orlistat, the other 36 did not. All patients received education and consultation. Outcomes included consistency in liver function tests (LFT) over one year and differences in BMI between the patients who received orlistat and matched controls who did not.

LFTs were analyzed with the intraclass correlation coefficient (ICC). The authors reported a moderately strong agreement among LFT , specifically serum glutamic pyruvic transaminase (SGPT), values at baseline, 6 months, and one year (ICC = 0.69), concluding that orlistat did not result in any significant liver injury after one year.

A significant change in BMI after 6 months of treatment was seen in the patients receiving Orlistat (-1.344, p < 0.01) when compared with the patients who received only education and consultation (0.124). This change was sustained at one year.

The authors concluded that orlistat “is a safe and effective medication with negligible systemic absorption” for use in obese patients. Furthermore, the concern about hepatotoxicity with orlistat “appears to be highly exaggerated” and “should not deter” physicians from prescribing it to obese patients who may benefit from it.

The authors report no disclosures.