Rational approach to patients treatment with type 2 diabetes and obesity: results of the All-Russian observational program «AURORA»

Abstract

Background: As in many other developed nations, the problem of obesity and type 2 diabetes is acute in Russia. In Russia, the only combination of sibutramine and metformine (ReduxinMet) is authorized to reduce body mass and prevention development of type 2 diabetes mellitus or its complication. The article presents the results of the observational program AVRORA.
 Aim: Evaluation of the effectiveness and safety of ReduxinMet (sibutramine + microcrystalline cellulose + Metformin) in patients with type 2 diabetes and alimentary obesity in routine clinical practice.
 Materials methods: The observational program AVRORA was conducted from September 2016 to October 2017 under the auspices of the Endocrinological Scientific Center and the Russian Association of Endocrinologists. The AVRORA program was a multicenter, non-interventional study of patients to whom the attending physicians prescribed ReduxinMet, a set (tablets + capsules), in accordance with the instruction for medical use as part of routine clinical practice. The treated group included patients of both sexes, aged 1865 years, with an established diagnosis of obesity in combination with type 2 diabetes. The duration of the drug usage was determined by the attending physician and was up to 6 months. ReduxineMet was prescribed in addition to the existing glucose-lowering therapy, the dose of metformin was adjusted to the patient's needs.
 Results: The AVRORA study was attended by 259 doctors and 5,812 patients in 240 medical institutions from 12 cities of the Russian Federation. The average age of patients was 46.6 10.5 years, the ratio of male / female -24% / 76%. The decreasing of BMI during 6 months of the therapy amounted to 5.4 2.3 kg / m2 (on average, 15.1 6.4 kg). After 3 months of the therapy 81.6% of patients achieved clinically significant weight loss of 10.6% or more. The average decrease in waist circumference during 6 months of therapy was 13.8 7.4 cm. A decrease of indicators of glycemic control and lipid metabolism right up to the target values was observed.
 Conclusions: In AVRORA study it was shown that addition of ReduxineMet (sibutramine+ microcrystalline cellulose+metformine) to the complex therapy of the diabetes in combination with obesity according to approved indications is safe and effective for long-term treatment in regards to weight loss, regulation of lipemic index, glucose profile and quality of life.