Orlistat - Weight Loss and Prevention
of Weight Regain in Obese Patients
Weight Loss Study Aim
We undertook a randomised controlled trial to assess the efficacy and
tolerability of orlistat, a gastrointestinal lipase inhibitor, in promoting
weight loss and preventing weight regain in obese patients over a 2-year
period.
Weight Loss Study Methods
743 patients (body-mass index 28-47 kg/m2), recruited at 15 European centres,
entered a 4-week, single-blind, placebo lead-in period on a slightly hypocaloric
diet (600 kcal/day deficit). 688 patients who completed the lead-in were
assigned double-blind treatment with orlistat 120 mg (three times a day)
or placebo for 1 year in conjunction with the hypocaloric diet. In a second
52-week double-blind period patients were reassigned orlistat or placebo
with a weight maintenance (eucaloric) diet.
Weight Loss Study Results
From the start of lead-in to the end of year 1, the orlistat group lost,
on average, more bodyweight than the placebo group (10.2 percent [10.3
kg] vs 6.1 percent [6.1 kg]; LSM difference 3.9 kg from randomisation
to the end of year 1). During year 2, patients who continued with orlistat
regained, on average, half as much weight as those patients switched to
placebo. Patients switched from placebo to orlistat lost an additional
0.9 kg during year 2, compared with a mean regain of 2.5 kg in patients
who continued on placebo. Total cholesterol, low-density lipoprotein (LDL)
cholesterol, LDL/high-density lipoprotein ratio, and concentrations of
glucose and insulin decreased more in the orlistat group than in the placebo
group. Gastrointestinal adverse events were more common in the orlistat
group. Other adverse symptoms occurred at a similar frequency during both
treatments.
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Weight Loss Study Conclusions
Orlistat taken with an appropriate diet promotes clinically significant
weight loss and reduces weight regain in obese patients over a 2-year
period. The use of orlistat beyond 2 years needs careful monitoring
with respect to efficacy and adverse events.
Source; Sjostrom L, Rissanen A, Andersen
T, Boldrin M, Golay A, Koppeschaar HP, Krempf M. Sahlgrenska University
Hospital, Goteborg, Sweden. 1998
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