[Efficacy and safety of a short-time orlistat treatment in obese subjects]

Author: Gruppo Campano Obesita

Author affiliation: Dipartimento di Gerontologia, Geriatria e Malattie del Metabolismo, Seconda Universita degli Studi di Napoli. sandro.gentile@unina2.it

Publication date & source: 2005.04, Ann Ital Med Int., 20(2):90-6.

Publication type: Clinical Trial; English Abstract; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

Obesity is frequently associated with a high cardiovascular risk. The aim of this study was to assess safety, tolerability and efficacy of orlistat treatment in comparison with placebo in the reduction of body weight in obese subjects and the related cardiovascular risk factors. For such a purpose, 146 obese patients were randomly assigned to two treatments over a period of 27 weeks: 1) hypocaloric diet, exercise and placebo (n = 72); 2) hypocaloric diet, exercise and orlistat 120 mg twice/day (n = 74). The side effects observed were similar for the two treatment groups, with exception of gastrointestinal symptoms, which were significantly more frequent in the orlistat group than in the placebo group. Nevertheless, the side effects were limited and resolved. In fact, none of the patients dropped-out. During the observation period a significantly higher reduction in body weight (-6.9 kg, p < 0.001), systolic blood pressure (-4.9 mmHg, p < 0.001), diastolic blood pressure (-2.9 mmHg, p < 0.001), LDL cholesterol (12.8%, p < 0.001) was observed in the orlistat group than in the placebo group (-4.1 kg, 3.2 mmHg, 1.8 mmHg and 5.1%, respectively). By using a validated questionnaire, in the orlistat group a significantly higher motivation (p < 0.01) to continue diet and exercise than in the placebo group was observed. In addition, at the end of the study, patients receiving orlistat treatment gave a better evaluation of their own image than patients receiving placebo (p < 0.01).