Effectiveness

Comprehensive clinical trials were performed to document the safety and efficacy of Reductil®. Patients included in the trials suffered from simple obesity as well as from obesity with concomitant diseases, i. e. diabetes, dyslipidaemia and hypertension.

All studies have shown, that sibutramine has a firm weight-reducing effect.

Weight loss is greatest for the first 3 months. This is continued by smaller steps of weight loss up to 6 months and sustained throughout the treatment period up to 12 months as shown in the long- term studies.

Over the dose range 1-30 mg/ day, the effect on weight loss is dose-related. The minimal dose of sibutramine producing statistically significant weight loss is 5 mg/ day, but doses of 10 mg/ day or greater are required for clinically significant weight loss in most patients with obesity.

The optimum Reductil® doses, which combine clinically and statistically significant weight loss with optimum tolerability, are 10 mg and 15 mg.

Obesity with Concomitant Diseases

Several studies have investigated the effect of sibutramine in obese patients with co- morbidities such as diabetes mellitus, hypertension and dyslipidaemia. Patients with type 2 diabetes lose weight at a slower rate than obese patients without diabetes.

Sibutramine was found to be effective in producing weight loss in obese patients with hypertension and did not adversely affect the management of hypertension.

A meta- analysis of serum lipid changes in six placebo- controlled studies has shown that sibutramine in patients with dyslipidaemia produces weight loss with statistically significant improvements in lipid variables.