Orlistat, Weight Loss & Glucose Study
Latin-American trial of orlistat for weight
loss and improvement in glycemic profile in obese diabetic patients.
Orlistat Weight Loss Study - Aim
To determine if obese non-insulin-dependent diabetic patients lose more
weight when treated for 24 weeks (6 months) with orlistat (120 mg t.i.d.),
in conjunction with a hypocaloric diet plus behavioural counselling, than
when treated by placebo (t.i.d.) plus similar instructions. The secondary
objectives were to evaluate the effects on glucose profile and to determine
the tolerability and safety of orlistat.
Orlistat Weight Loss Study - Method
Double-blind, parallel, randomized, placebo-controlled, multicentre study.
Subjects included obese, non-insulin-dependent diabetic patients, aged
18-70 years old, with BMI > 27 kg/m2, evaluated at 10 Latin-American
centres, in five countries. After screened, eligible patients passed by
a 2-week placebo run-in period receiving a hypocaloric diet.
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On day 0, patients were randomized
to orlistat or placebo for 24 weeks. At each visit, body weight,
blood pressure and waist circumference were measured. At the screening
visit, baseline visit (week 0), and at weeks 8, 16 and 24, a central
laboratory was in charge of measuring fasting glucose and insulin,
HbA1c, postprandial glucose and insulin, fasting total cholesterol,
HDL-cholesterol, LDL-cholesterol, triglycerides, and postprandial
triglycerides. Other safety laboratory assessments were measured
locally at the screening visit, baseline visit and at the end of
the study. Adverse events were assessed at each visit from baseline.
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Orlistat Weight Loss Study - Results
After 24 weeks of treatment, the orlistat group lost an average of 4.7
percent of initial body weight vs. 3.0 percent in the placebo group (p
= 0.0003). A greater weight loss was achieved in the orlistat compared
with the placebo group. Almost twice as many patients receiving orlistat
lost more or equal to 5 percent of initial body weight. Orlistat treatment
plus diet compared to placebo plus diet was associated with significant
improvement in glycaemic control, fasting plasma glucose and postprandial
glucose. Orlistat-treated patients had a mean decrease in glucose levels
for placebo group, at week 24. Orlistat therapy also resulted in significantly
greater improvements than placebo in lipid profile, with reductions in
total cholesterol. Mild to moderate transient gastrointestinal events
were reported, mainly with orlistat treatment, but their association with
withdrawal from the study was low.
Orlistat Weight Loss Study - Conclusion
Orlistat is a useful and an effective therapy in obese diabetic patients,
promoting clinically significant weight loss and improved glycaemic control
and lipid profile.
Source: Hospital das Clinicas, Faculdade
de Medicina da Universidade de Sao Paulo, Brazil 2003
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