OBJECTIVE: Bile acid-sequestering resins are known to be potent hypocholesterolaemic drugs, and a feeling of abdominal fullness has been reported as the most frequent adverse effect associated with their use. However, this unique adverse effect of colestilan, abdominal fullness, may have the potential to reduce total food intake. The aim of this study was to investigate the effect of colestilan, a new bile acid-sequestering resin, on the bodyweight of postmenopausal women who had previously dieted unsuccessfully. METHODS:Forty postmenopausal women who failed to diet successfully over a 4-week period were enrolled in this randomised, open-label, controlled study. Subjects were randomised to two groups: the colestilan group received four colestilan tablets administered in divided doses with three glasses of water before dinner and bedtime for 12 weeks; the control group received three glasses of water before dinner and bedtime for 12 weeks. All patients were monitored and were given the same diet instructions. RESULTS: Twelve weeks' administration of colestilan in addition to diet instruction significantly reduced bodyweight and body mass index from 62.9 +/- 5.7kg to 58.0 +/- 5.4kg (mean +/- SD) and from 26.1 +/- 2.0 kg/m2 to 23.9 +/- 2.0 kg/m2, respectively. There were no significant differences in bodyweight before and after 12 weeks of treatment in the control group. CONCLUSION: Colestilan may be useful for appetite control and exerts anti-obesity effects when used in conjunction with a weight-management programme.
RCT Entities:
OBJECTIVE:Bile acid-sequestering resins are known to be potent hypocholesterolaemic drugs, and a feeling of abdominal fullness has been reported as the most frequent adverse effect associated with their use. However, this unique adverse effect of colestilan, abdominal fullness, may have the potential to reduce total food intake. The aim of this study was to investigate the effect of colestilan, a new bile acid-sequestering resin, on the bodyweight of postmenopausal women who had previously dieted unsuccessfully. METHODS: Forty postmenopausal women who failed to diet successfully over a 4-week period were enrolled in this randomised, open-label, controlled study. Subjects were randomised to two groups: the colestilan group received four colestilan tablets administered in divided doses with three glasses of water before dinner and bedtime for 12 weeks; the control group received three glasses of water before dinner and bedtime for 12 weeks. All patients were monitored and were given the same diet instructions. RESULTS: Twelve weeks' administration of colestilan in addition to diet instruction significantly reduced bodyweight and body mass index from 62.9 +/- 5.7kg to 58.0 +/- 5.4kg (mean +/- SD) and from 26.1 +/- 2.0 kg/m2 to 23.9 +/- 2.0 kg/m2, respectively. There were no significant differences in bodyweight before and after 12 weeks of treatment in the control group. CONCLUSION:Colestilan may be useful for appetite control and exerts anti-obesity effects when used in conjunction with a weight-management programme.