Trial Results related to Xenical (Orlistat)
To evaluate the efficacy and tolerability of this drug, we executed
clinical tests . The main goal was to check the weight loss and the weight
gaining prevention in obese patients over a 2-year period.
743 individuals (BMI 28—47 kg/m2), within 15 European centres. They entered a 4-week, single-blind, placebo lead-in period on a hypocaloric diet (600 kcal/day deficit).
From the 743 patients, 688 completed the lead-in and were addressed to a double-blind treatment with
Xenical 120 mg (three times a day) or a placebo for 1 year, together with
a hypocaloric diet. In a second 52-week double-blind period patients were reassigned orlistat or placebo with a weight maintenance (eucaloric) diet.
From day 1 to the end of the first year, the orlistat group lost, on average, more
weight than the placebo group (10·2% [10·3 kg] vs 6·1% [6·1 kg]; LSM difference 3·9 kg [p < 0·001] from randomisation to the end of
the first 12 months). During the second year, patients who kept orlistat regained, on average, half as much weight as those patients switched to placebo (p < 0·001). Patients switched from placebo to orlistat lost an
extra 0·9 kg during the second year, when compared with a of 2·5 kg in
individuals who continued with placebo (p < 0·001). Values related to low-density lipoprotein (LDL) cholesterol, LDL/high-density lipoprotein
ratio, total cholesterol and glucose and insulin concentrations decreased more in the
Xenical group. As expected, the gastrointestinal side effects were more
usual in the orlistat group.
We can conclude that Xenical together with an appropriate diet grants a
considerable weight loss and prevents the weight from returning. Such was
proved in patients over a 2-year period. However, taking Xenical more than 2
years requires ongoing monitoring in regards to efficacy and side effects.
Presented by: European Multicentre Orlistat Study Group