[Sibutramine in clinical practice - a PMS-study with positive effects on blood pressure and metabolic parameters]

Abstract

Background and aim of the study: According to the latest health-survey data of the Robert Koch Institute, more than a fifth of all Germans are obese and about two thirds are overweight. As non-pharmacological therapies have failed to a large extent in the past, this post-marketing surveillance study was conducted to examine the feasibility, safety and efficacy of a medical weight reduction.

Patients and methods: 6360 patients with a BMI of at least 30 kg/m(2) or, in the case of further risk factors, of 27 kg/m(2) or more, were included in the trial; the inclusion criteria and exclusion criteria chosen adhered strictly to the directions of use given for sibutramine. Two thirds of the patients had concomitant diseases and/or concomitant risk factors, and 62.4 % used concomitant medications. After being informed about non-medical therapies, the patients received 10 mg sibutramine once daily. After four weeks this treatment could be continued, terminated or increased to a dosage of 15 mg sibutramine per day.

Results: The body weight was reduced from 98.4 kg to 88.4 kg within the 12 weeks of treatment, which corresponds to a mean reduction of the BMI of 3.7 kg/m (2) and which was accompanied by clinically relevant reductions of waist and hip measurements. The following metabolic parameters improved significantly: cholesterol, LDL, HDL, triglycerides, blood glucose, HbA1c and uric acid. Whereas the blood pressure of normotensive patients was unchanged during the course of the study, or increased very slightly, for patients presenting with hypertension at baseline a significant decrease in blood pressure could be observed (-7.3/-4.0 mmHg), which was all the more pronounced, the higher the baseline values had been.

Conclusion: Under real practice conditions, for overweight and obese patients treatment with sibutramine led to significant weight reductions and was well tolerated. The metabolic and cardiovascular risk profile was significantly improved, which was especially beneficial for patients with a high baseline risk.