Email this article DEVELOPMENT OF THERAPEUTIC STRATEGIES FOR OBESITY AND COMORBID DISORDERS BASED ON OBSERVATIONAL PROGRAMS: INTERIM RESULTS OF THE RUSSIAN OBSERVATIONAL PROGRAM PRIMAVERA
- Authors: Troshina E.A.1, Mazurina N.V.1, Galieva M.O.1
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Affiliations:
- Federal Research Centre of Endocrinology, Moscow
- Issue: 2015: Supplement 1
- Pages: 95-101
- Section: THE PROBLEM OF OBESITY
- URL: https://almclinmed.ru/jour/article/view/87
- DOI: https://doi.org/10.18786/2072-0505-2015-1-95-101
- ID: 87
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Abstract
Aim: To assess interim results of the Russian observational program PrimaVera on efficacy and safety sibutramine (Reduxin®) for treatment of obesity within routine medical practice.
Materials and methods: This multicenter observational program included patients with obesity aged below 65 years, excluding those with uncontrolled arterial hypertension, coronary heart disease, heart failure and cerebrovascular disease. All patients were administered sibutramine for treatment of their obesity. During out-patient follow-up visits, physicians assessed changes in patients’ body mass, blood pressure and heart rate, as well as registered adverse events. Maximal treatment duration was 12 months. In this report, the results from 16 515 patients are analyzed, 82% of whom (n=13 192) were females.
Results: After 3 months of treatment body mass index (BMI) decreased by 2.81±1.0 kg/m², after 6 months, by 5.17±2.15 kg/m². At 12 months decrease in BMI was 1.3-fold higher compared to 6 months’ results and amounted to 6.76±2.93 kg/m². Reduction of body mass with longterm (above 6 months) treatment with sibutramine under supervision of a physician was associated with a decrease in systolic and diastolic blood pressure levels (by 4.1 mm Hg, in both cases) and did not lead to an increase in heart rate (Δ=-1.02 bpm). Based on data from 16 515 medical records processed up to now, 397 episodes of adverse events were registered, with none of them being serious.
Conclusion: This interim results of the program PrimaVera confirmed favorable safety profile of Reduxin® and its high efficacy in the treatment of obesity.
About the authors
E. A. Troshina
Federal Research Centre of Endocrinology, Moscow
Author for correspondence.
Email: troshina@inbox.ru
Troshina Ekaterina Anatol'evna – MD, PhD, Professor, Head of Department of Treatment of Endocrinopathies with the Obesity Group
* 11 Dmitriya Ul'yanova ul., Moscow, 117036, Russian Federation. Tel.: +7 (495) 124 35 02. E-mail: troshina@inbox.ru
РоссияN. V. Mazurina
Federal Research Centre of Endocrinology, Moscow
Email: troshina@inbox.ru
Mazurina Nataliya Valentinovna – PhD, Leading Research Fellow, Department of Treatment of Endocrinopathies with the Obesity Group
РоссияM. O. Galieva
Federal Research Centre of Endocrinology, Moscow
Email: troshina@inbox.ru
Galieva Marina Olegovna – Postgraduate Student, Department of Treatment of Endocrinopathies with the Obesity Group Россия
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