THE USE OF MULTI-COMPONENT THERAPY IN THE MANAGEMENT OF METABOLIC SYNDROME

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Abstract

Background: The metabolic syndrome (MS) is a cluster of hormonal and metabolic abnormalities arising from insulin resistance. It is associated with high risk of diabetes and cardiovascular disease. To reduce this risk, correction of the key pathophysiological factor of MS is recommended, namely, abdominal obesity. However, conventional non-medical treatment approaches (lifestyle changes and diet), as well as medical therapy with metformin frequently do not provide significant and consistent reduction in body weight. With all this, the use of sibutramine, a centrally active anti-obesity agent, looks promising. Being a selective inhibitor of re-uptake of neurotransmitters serotonin and norepinephrine, this agent promotes decreased appetite and weight loss in combination with diet and exercise.

Aim: To compare efficacy of lifestyle intervention only to that of lifestyle intervention plus metformin monotherapy or lifestyle intervention plus combination therapy with sibutramine and metformin with regard to anthropometric and metabolic parameters in MS patients.

 Materials and methods: This was a prospective, open-label, randomized, comparative study in 3 parallel groups. Sixty patients (mean age 45.4 ± 7.5 years) with MS (according to IDF 2005 criteria) were enrolled and randomized into 3 groups at 1:1:1 ratio. For 24 weeks, patients in the group 1 (n = 20) were on metformin monotherapy, those in the group 2 (n = 20) on combined therapy with sibutramine and metformin and patients from the group 3 (control group, n = 20) were given recommendations on lifestyle change only. The groups were matched for baseline clinical characteristics and demographics. All patients were instructed on diet, physical activity, and lifestyle changes. Anthropometric and metabolic parameters were assessed at baseline, weeks 4, 12 and 24.

 Results: The group on combination therapy with sibutramine/metformin showed the highest mean percentage of decrease in body mass, body mass index and waist circumference. Under combination therapy, waist circumference decreased by 2.3 ±0.57 cm (р < 0.05), waist/hip ratio by 2.72% (р < 0.05). Serum ALT activity in both groups on medical treatment decreased significantly (by 27.5% in group 1 and by 28.07% in group 2, p < 0.05 for comparison with baseline values) which indicates an improvement of liver function in MS patients. At week 24, there were clinically significant improvements of lipid profile in both medical treatment groups. In group 2, there was more advanced decrease in triglyceride levels, compared to group 1 (by 24.5% vs. 11.2%, p < 0.05). There were no serious adverse events related to the drugs during the study.

Conclusion: Combination of sibutramine with metformin is effective, safe and well tolerated for correction of excess weight in patients with MS, in whom metformin monotherapy is ineffective. 

About the authors

S. V. Nedogoda

Volgograd State Medical University

Author for correspondence.
Email: nedogodasv@rambler.ru

Nedogoda Sergey Vladimirovich – MD, PhD, Professor, Head of Department of Therapy and Endocrinology, Postgraduate Training Faculty

* 1 Tsiolkovskogo ul., Volgograd, 400001, Russian Federation. Tel.: +7 (8442) 97 42 51. E-mail: nedogodasv@rambler.ru

Russian Federation

I. N. Barykina

Volgograd State Medical University

Email: nedogodasv@rambler.ru
Barykina Irina Nikolaevna – MD, PhD, Research Assistant, Department of Therapy and Endocrinology, Postgraduate Training Faculty Russian Federation

A. S. Salasyuk

Volgograd State Medical University

Email: nedogodasv@rambler.ru
Salasyuk Alla Sergeevna – MD, PhD, Research Assistant, Department of Therapy and Endocrinology, Postgraduate Training Faculty Russian Federation

V. Yu. Khripaeva

Volgograd State Medical University

Email: nedogodasv@rambler.ru
Khripaeva Viktoriya Yur'evna – Postgraduate Student, Department of Therapy and Endocrinology, Postgraduate Training Faculty Russian Federation

V. O. Smirnova

Volgograd State Medical University

Email: nedogodasv@rambler.ru
Smirnova Viktoriya Olegovna – Postgraduate Student, Department of Therapy and Endocrinology, Postgraduate Training Faculty Russian Federation

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Copyright (c) 2016 Nedogoda S.V., Barykina I.N., Salasyuk A.S., Khripaeva V.Y., Smirnova V.O.

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