Orlistat and Obesity Management
Weight Loss Study Aim
This paper describes the methodology of a multicenter study designed to
assess the efficacy and tolerability of orlistat 120 mg as therapy for
inducing weight loss in excess of that achieved with a moderately calorie-restricted
diet alone. The results from a single centre are presented to illustrate
the nature of the response.
Weight Loss Study Design
This was a double-blind, randomized, parallel-group, placebo-controlled
multicenter study. A four-week, single-blind, placebo run-in period preceded
a 52 week double-blind treatment period during which patients received
either orlistat or placebo three times a day. At the start of the run-in
period, all patients were placed on a diet containing approximately 30
percent of calories as fat and designed to cause an energy deficit of
approximately 600 kcal/d.
Weight Loss Study Subjects
Patients of either sex, more than 18 years of age, with a body mass index
(BMI) between 30 and 43 kg/m2 were eligible for enrolment.
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Weight Loss Study Results
In the single centre there was a reduction in body weight (5.7
percent reduction) in the placebo group and in the orlistat-treated
group (8.4 percent reduction) in six months. Thereafter, the placebo
group tended to relapse whereas the orlistat group maintained their
loss (2.6 percent vs 8.4 percent reduction from initial value at
52 weeks). Total and LDL cholesterol fell by 0.05 mmol/l (1.6 percent)
and 0.14 mmol/l (4.2 percent), respectively, in orlistat treated
patients. The drop-out rate was 48 percent in the placebo group
and 39 percent in the orlistat group.
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Intestinal symptoms related to orlistat were significantly increased compared
to placebo but were well tolerated. Fat soluble vitamin levels remained
within the normal range in the treatment group; the reduction seen in alpha-tocopherol
levels in patients receiving orlistat was normalized by the decrease in
plasma cholesterol concentrations. Beta-carotene and vitamin D concentrations
also decreased in orlistat-treated patients.
Weight Loss Study Conclusions
This preliminary analysis suggests that orlistat, when used with a health-promoting
low-fat and moderately energy-restricted diet, confers advantages in the
long-term management of obesity.
Source: James WP, Avenell A, Broom J, Whitehead
J. Rowett Research Institute, Bucksburn, Aberdeen. 1997
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