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Orlistat/Xenical Diet Pills Trial
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Clinical Weight Loss Trials of Diet Pills

Clinical Weight Loss Trials of Orlistat (Xenical) Prescription Diet Pills

Predictive value of early weight loss in obesity management with Orlistat prescription diet pills: an evidence-based assessment of prescribing guidelines.

Aim
To assess the clinical usefulness of published guidelines for the use of orlistat prescription diet pills, by studying whether weight loss of 2.5 kg or more during a 4 week dietary lead-in period, and weight losses of 5 percent or more after 12 weeks and 10 percent or more after 6 months of drug therapy predict weight loss and risk factor changes after 2 years.

Method
A retrospective analysis of pooled data from 2 multicentre, randomised, placebo-controlled clinical trials with similar design. The setting for the weight loss study was 29 centres throughout Europe. Subjects were 220 men and women (BMI 28-43 kg/m(2)) who completed 2 years of treatment.

Intervention
After a 4 week hypocaloric diet plus placebo, 2 years of treatment with orlistat 120 mg tid, plus a hypocaloric diet for the first year and a weight maintenance diet in year two.

Results
Weight loss 5 percent or more of body weight after 12 weeks of diet plus orlistat therapy was a good indicator of 2 year weight loss, whereas weight loss of 2.5 kg or more during the 4 week lead-in and 10 percent or more after 6 months did not add significantly to the prediction of 2 year outcomes. Patients who lost 5 percent or more of their weight at 12 weeks lost significantly more weight after 2 years than others: -11.9 percent (95 percent confidence interval (CI) and had significantly greater reductions in total cholesterol, LDL-cholesterol, triglycerides, glucose, insulin, and blood pressure. Among those who achieved 5 percent or more weight loss at 12 weeks, the overall health benefits were not significantly greater in patients who went on to lose 10 percent or more of body weight at 6 months compared with those who did not achieve 10 percent or more of weight loss by month 6.

Conclusions
Of the criteria currently suggested for assessing response to orlistat treatment, weight loss of 5 percent or more at 12 weeks accurately predicts sustained improvements in weight and major risk factors at 2 years, while other suggested criteria are less useful.

Source: Rissanen A, Lean M, Rossner S, Segal KR, Sjostrom L. Obesity Research Unit, Helsinki University Central Hospital, Helsinki, Finland.

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