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Therapeutics |
Design
Randomised (allocation concealed*), blinded (investigators and patients),* placebo controlled trial with 44 weeks of follow up after randomisation.
Setting
108 private practices and 3 hospital outpatient departments in Germany.
Patients
1001 patients who were 18 to 65 years of age (mean age 43 y, 77% women), had a body mass index (BMI) of 30 to 40 kg/m2, and had
1 previous unsuccessful attempt at losing weight by using dietary measures. Exclusion criteria were serious cardiovascular or metabolic diseases; history of drug or alcohol abuse; need for antidepressants, ß;-blockers, or any drugs influencing body weight; or inadequate contraception in women of childbearing age. 79% of patients completed the study; all patients were included in the analysis.
Intervention
Patients who responded (ie, weight loss of
2% or
2 kg) to sibutramine 15 mg/day, during a 4 week run-in period, were allocated to 1 of 3 groups for 44 more weeks: continuous sibutramine 15
Lawrence J Cheskin, MD
Johns Hopkins Bloomberg School of Public Health Baltimore, Maryland, USA
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