Objective: The aim of the study was to assess the effectiveness and safety of long-term sibutramine therapy in routine clinical practice.
Materials and methods: In total, 98 774 patients (82.3% women, 17.7% men), from 142 cities of the Russian Federation were enrolled in the PRIMAVERA program. The mean age of the patients was 39.39±10.38 years, the mean body weight was 99.1±14.28 kg, and the mean BMI was 35.7±4.41 kg/m2. Physicians determined the duration of the sibutramine therapy taking into consideration clinical conditions: 59.3% of patients took the drug for six months, the treatment course of 37.7% of patients was 12 months, and 3% of patients had treatment for three months.
Results: BMI reduction correlated with the treatment duration: 3.4±1.53 kg/m2 after three months of therapy, 5.4±2.22 kg/m2 after 6 months, and 7.2±3.07 kg/m2 after 12 months. The body weight reduction after 3, 6 and 12 months of treatment was 9.5%, 15.1%, and 19.7%, respectively. The body weight loss associated with the sibutramine treatment was accompanied by a slight decrease in blood pressure and did not lead to any significant increase in the heart rate (HR).
Conclusions: The results of the PRIMAVERA study confirmed the lack of increased risk of using sibutramine in routine clinical practice in patients without underlying cardiovascular disease and low rate of adverse events.
18 May 2019 - 21 May 2019