Clinical
Weight Loss Trials of Diet Pills
Diet Pills Trial - Xenical/Orlistat, Weight
Loss & Glucose
Latin-American trial of Xenical/Orlistat
for weight loss and improvement in glycaemic profile in obese diabetic
patients.
Aim of Diet Pills Trial
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.
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 Xenical/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.
Results
After 24 weeks of treatment, the Xenical/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.
Diet Pills Conclusion
Xenical/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
Some Clinical Weight Loss Trials of Diet
Pills
Xenical
Diet Pills and Diabesity
Laxatives & Diet Pills
CLA Dietary Pills Trial
Orlistat Diet Pills Trial
Xenical/ Meridia Diet Pills
Xenical/ Orlistat Diet
Pills Trial
Meridia Diet Pills
Meridia & Dexfenfluramine
Sibutramine Diet Pills:
Health Trial
Meridia Diet Pills: Energy
Trial
Sibutramine Diet
Pills: Drug Abuse Trial
Sibutramine Diet Pills Trial
Sibutramine Diet Drugs:
Energy Trial
Orlistat/ Sibutramine
Diet Pills Trial
Orlistat/ Xenical Diet
Pills Trial
Dietary Supplements:
Weight Loss Trial
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