Weight Loss Study About Orlistat
Predictive value of early weight loss in
obesity management with orlistat: an evidence-based assessment of prescribing
guidelines.
Orlistat Study - Aim
To assess the clinical usefulness of published guidelines for the use
of orlistat, 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.
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Orlistat Study - 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.
Orlistat Study - 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.
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Orlistat Study - 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.
Orlistat Study - 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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