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Orlistat, Weight Loss and Glucose Study
Orlistat Trial for Glycemic Benefits in Obese Diabetic Patients
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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.

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.

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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