Альманах клинической медицины. 2015; 1: 95-101
СОЗДАНИЕ СТРАТЕГИЙ ЛЕЧЕНИЯ ОЖИРЕНИЯ И КОМОРБИДНЫХ ЗАБОЛЕВАНИЙ НА ОСНОВЕ НАБЛЮДАТЕЛЬНЫХ ПРОГРАММ: ПРОМЕЖУТОЧНЫЕ РЕЗУЛЬТАТЫ ВСЕРОССИЙСКОЙ НАБЛЮДАТЕЛЬНОЙ ПРОГРАММЫ ПримаВера
https://doi.org/10.18786/2072-0505-2015-1-95-101Аннотация
Цель – оценить промежуточные результаты Всероссийской наблюдательной программы ПримаВера по оценке эффективности и безопасности лечения ожирения комбинированным препаратом сибутрамина и микрокристаллической целлюлозы (Редуксин®) в условиях повседневной медицинской практики.
Материал и методы. В многоцентровую наблюдательную программу вошли пациенты с ожирением в возрасте до 65 лет, за исключением имевших неконтролируемую артериальную гипертонию, ишемическую болезнь сердца, сердечную недостаточность и цереброваскулярные заболевания. Всем пациентам для лечения ожирения был назначен сибутрамин. На амбулаторных визитах врачи оценивали динамику массы тела, артериальное давление и частоту сердечных сокращений, а также регистрировали нежелательные явления. Максимальная продолжительность терапии составила 12 месяцев. В данной публикации проанализированы результаты 16 515 пациентов, 82% из которых (n=13 192) составили женщины.
Результаты. Через 3 месяца лечения индекс массы тела (ИМТ) снизился на 2,81±1,0 кг/м², через 6 месяцев – на 5,17±2,15 кг/м². За 12 месяцев снижение ИМТ было в 1,3 раза более выраженным по сравнению с результатами лечения в течение 6 месяцев и составило 6,76±2,93 кг/м². Уменьшение массы тела при длительной (более 6 месяцев) терапии сибутрамином под контролем врача сопровождалось снижением уровня систолического и диастолического артериального давления на 4,1 мм рт. ст. в обоих случаях и не приводило к повышению частоты сердечных сокращений (Δ=-1,02 уд/мин). Среди обработанных к настоящему моменту данных по 16 515 картам пациентов было зарегистрировано 397 случаев возникновения нежелательных явлений, при этом ни одного серьезного.
Заключение. Промежуточные результаты реализации программы ПримаВера подтвердили благоприятный профиль безопасности препарата Редуксин® и его высокую эффективность в лечении ожирения.
Список литературы
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Almanac of Clinical Medicine. 2015; 1: 95-101
DEVELOPMENT OF THERAPEUTIC STRATEGIES FOR OBESITY AND COMORBID DISORDERS BASED ON OBSERVATIONAL PROGRAMS: INTERIM RESULTS OF THE RUSSIAN OBSERVATIONAL PROGRAM PRIMAVERA
https://doi.org/10.18786/2072-0505-2015-1-95-101Abstract
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.
References
1. World Health Organization. Obesity: preventing and managing the global epidemic. WHO, 2000.
2. Vsemirnaya organizatsiya zdravookhraneniya. Ozhirenie i izbytochnyi ves. Informatsionnyi byulleten' VOZ № 311. Mai 2014. Dostupno na: http://www.who.int/mediacentre/ factsheets/fs311/ru/ (World Health Organization. Obesity and overweight. Fact sheet No. 311. Reviewed May 2014. Available at: http://www.who.int/mediacentre/factsheets/fs311/en/).
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4. Brixner D, Ghate SR, McAdam-Marx C, BenJoseph R, Said Q. Association between cardiometabolic risk factors and body mass index based on diagnosis and treatment codes in an electronic medical record database. J Manag Care Pharm. 2008;14(8):756–67.
5. Després JP, Poirier P, Bergeron J, Tremblay A, Lemieux I, Alméras N. From individual risk factors and the metabolic syndrome to global cardiometabolic risk. Eur Heart J Suppl. 2008;10(Suppl B):B24–B33.
6. Dattilo AM, Kris-Etherton PM. Effects of weight reduction on blood lipids and lipoproteins: a meta-analysis. Am J Clin Nutr. 1992;56(2):320–8.
7. Leenen R, van der Kooy K, Meyboom S, Seidell JC, Deurenberg P, Weststrate JA. Relative effects of weight loss and dietary fat modification on serum lipid levels in the dietary treatment of obesity. J Lipid Res. 1993;34(12):2183–91.
8. Kannel WB. Hypertension: reflections on risks and prognostication. Med Clin North Am. 2009;93(3):541–58.
9. Lenz M, Richter T, Mühlhauser I. The morbidity and mortality associated with overweight and obesity in adulthood: a systematic review. Dtsch Arztebl Int. 2009;106(40):641–8.
10. Guh DP, Zhang W, Bansback N, Amarsi Z, Birmingham CL, Anis AH. The incidence of comorbidities related to obesity and overweight: a systematic review and meta-analysis. BMC Public Health. 2009;9:88.
11. Vazquez G, Duval S, Jacobs DR Jr, Silventoinen K. Comparison of body mass index, waist circumference, and waist/hip ratio in predicting incident diabetes: a metaanalysis. Epidemiol Rev. 2007;29:115–28.
12. Anderson JW, Konz EC, Frederich RC, Wood CL. Long-term weight-loss maintenance: a meta-analysis of US studies. Am J Clin Nutr. 2001;74(5):579–84.
13. Avenell A, Brown TJ, McGee MA, Campbell MK, Grant AM, Broom J, Jung RT, Smith WC. What are the long-term benefits of weight reducing diets in adults? A systematic review of randomized controlled trials. J Hum Nutr Diet. 2004;17(4):317–35.
14. Orzano AJ, Scott JG. Diagnosis and treatment of obesity in adults: an applied evidence-based review. J Am Board Fam Pract. 2004;17(5): 359–69.
15. Douketis JD, Macie C, Thabane L, Williamson DF. Systematic review of long-term weight loss studies in obese adults: clinical significance and applicability to clinical practice. Int J Obes (Lond). 2005;29(10):1153–67.
16. Shestakova MV. Opyt primeneniya sitagliptina (pervogo ingibitora DPP-4) v lechenii sakharnogo diabeta 2 tipa v Rossiiskoi Federatsii: rezul'taty nablyudatel'noi programmy «Dia-Da». Sakharnyi diabet. 2010;(3):57–60. (Shestakova MV. Experience with sitagliptin (the first DPP-4 inhibitor) application to the treatment of type 2 diabetes mellitus in the Russian Federation: results of the DIA-DA observation program. Sakharnyy diabet. 2010;(3):57–60. Russian)
