Active Ingredient: Orlistat
Xenical is a weight loss dieting aid which prevents around a third of consumed fat being absorbed into the body.
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Compliance was assessed by counting the number of capsules returned by the patients at specified clinic visits and by calculating the number of capsules that had been consumed each day. Study design and assignment of subjects. AE, adverse event; tid, 3 times daily.
Measurements Clinic visits were scheduled weekly for the first 2 mo of the 6-mo lead-in weight-loss period and every 2 wk thereafter.
During the 1-y treatment period, subjects were seen on day 1, at 2-wk intervals during month 1, every month between months 1 and 5, and every 2 mo thereafter.
Body weight was measured at every clinic visit. Fasting serum glucose and insulin concentrations were also measured at these visits, with one additional measurement during both the 6-mo lead-in weight-loss period and the 1-y treatment period.
The pharmacodynamic effect of orlistat was assessed by measuring fecal fat content. Fecal collections were analyzed by Medi-Lab Bioprofil, Copenhagen.
All clinical complaints during the 6-mo lead-in weight-loss period and adverse events during the 1-y treatment period were recorded.
To ensure consistency of gastrointestinal event reporting between study centers, a dictionary of standard terms was used to describe changes in defecation patterns. Statistical analysis Efficacy analyses were performed on the intent-to-treat population, which consisted of subjects who received at least one dose of study medication during the 1-y treatment phase and for whom at least one body weight measurement was taken before and after random assignment.
The safety analysis population included all subjects who had received at least one dose of medication in a double-blind fashion and had at least one follow-up safety evaluation. For statistical analysis, both observed and derived last observation carried forward data were used.
However, all reported data were actual observed rather than derived values, whereas the technique of carrying forward the last observation was applied only for analyses of statistical significance.
The significance of between-group differences for percentage regain of lost weight was tested by applying analysis of covariance ANCOVA to the 1-y treatment period 15.