Marina Fedorovna Kalashnikova

Assessing routine healthcare pattern for type 2 diabetes mellitus in Russia: the results of рharmacoepidemiological study (FORSIGHT-DM2)

Rationale. xa0The rising incidence of type 2 diabetes mellitus (T2DM) allows researchers to conduct observational multicentre studies and obtain objective information about the epidemiology of diabetes and its complications and evaluate the efficacy of different therapies and diagnostic strategies designed to identify systemic vascular complications. Aims. To analyse epidemiological and socio-demographic parameters, the quality of glycaemic control, diagnostic monitoring and therapeutic measures typical among patients with T2DM living in Russian towns of different populations. Materials and methods. FORSIGHT-DM2 is an all-Russian multicentre observational epidemiological study that involves 2014 patients with T2DM from 45 different towns in the Russian Federation (RF). All patients have had T2DM for at least 1 year. They received glucose-lowering therapy and primary medical care from RF public outpatient health institutions between 01.01.2014 and 31.12.2014. For comparative analysis of the typical treatment for patients with T2DM, we stratified patients into groups based on the number of residents. Results. The data reveal a lack of glycaemic control (average НbА1сxa07.9% ± 1.9%), with НbА1сxa0> 8% in 36% of patients. The frequency of T2DM complications was high and the prevalence of retinopathy was 63.2%, nephropathy was 34.4% (7.8% had chronic kidney disease G3a-G5), peripheral polyneuropathy was 63.3%, ‘diabetic foot’ syndrome was 13.7% and osteoarthropathy was 5%. The number of T2DM-related complications is correlated with the HbA1cxa0level and disease duration. Moreover, simultaneous influence of these factors led to a significant increase in the number of chronic complications associated with T2DM (r = 0.338 for T2DM duration, r = 0.262 for HbA1c; р < 0.001). Despite the high frequency of patient consultations with endocrinologists (83%) and a large percentage of hospitalisations in the current year (46%), the screening of chronic complications of T2DM in 2014 is insufficient. Conclusion. The results indicate insufficient glycaemic control among patients with T2DM and a higher prevalence of chronic complications compared with the national register of diabetic patients.

Pharmacoepidemiological and pharmacoeconomic analyses of the utilization of hypoglycaemic drugs in patients with type 2 diabetes mellitus in Moscow

Pharmacoepidemiological research is the first stage of the clinical and economical evaluation of treatment with pharmaceutical agents. It plays an important role in providing reliable information about treatment regimens for patients with type 2 diabetes mellitus (T2DM). The results of the analysis of the utilisation of hypoglycaemic drugs are country specific and are associated with different epidemiological characteristics of the disease, cost of drugs and financing of the healthcare system. Analytical pharmacoeconomic studies allow the evaluation of the rational use of drugs, characteristics of treatment in clinical practice and their conformity to national and international clinical guidelines. Aim. To study the characteristics of treatment with insulin and oral hypoglycaemic drugs in Moscow-based patients with T2DM and to calculate the average cost of hypoglycaemic drugs per person per year. Materials and methods. A retrospective cohort pharmacoepidemiological study was performed by analysing information from the national register of diabetic patients from two administrative districts in Moscow. In total, 48,978 adult patients (older than 18 years) were registered with T2DM between 2000 and 2012. The study of treatment regimens was conducted using the standard international ATC/DDD methodology, and the correlation of fixed dose to appointed daily dose was calculated. The annual average cost of treatment for patients with T2DM, including different hypoglycaemic drugs (insulin and oral hypoglycaemic drugs) in the form of monotherapy and different combinations, was calculated. The average annual cost of hypoglycaemic therapy for patients with T2DM was calculated for the first time in the Russian Federation. Results. The majority of study patients received hypoglycaemic drugs (98.5%), and only 1.5% of the patients diagnosed with T2DM were on dietetic therapy. Of the patients receiving drugs, 90% received oral hypoglycaemic drugs, and 10% received insulin (basal-bolus regimen 4.6%, basal insulin with oral hypoglycaemic drugs 3.8% and ?MIX-insulin? 1.1%). The most frequently prescribed oral hypoglycaemic drugs were derivatives of sulphonyl urea and metformin (87% and 71%, respectively), and 12% of the patients received premixed combinations of these drugs. Other groups of oral hypoglycaemic drugs accounted for only a small proportion of oral hypoglycaemic drugs (approximately 2%) and included glinide (1.8% of the patients), thiazolidinedione (0.4%) and inhibitors of alpha-glucosidase (0.17%). In the group of derivatives of sulphonyl urea, the most frequently prescribed drugs were glibenclamide (46.4%), gliclazide (38.7%) and glimepiride (14%). The average annual treatment cost per patient was 7,467 rubles. Conclusion. The pharmacoeconomic analysis revealed that the treatment of T2DM was insufficiently effective in 48% of the patients (HbA 1c >7%). Most patients received monotherapy with metformin or derivatives of sulphonyl urea, among which glibenclamide was the most frequently prescribed drug. The treatment of patients with T2DM in 2011 was characterized by a low frequency of insulin prescription, rare usage of other groups of oral hypoglycaemic drugs (only 2%) and a mismatch between fixed dose and appointed daily dose. The average annual cost of hypoglycaemic drugs per patient with T2DM in 2011 in Moscow was 7,467 rubles.

Pharmacoeconomic aspects of the treatment of diabetic foot syndrome

Treatment of patients with diabetic foot syndrome (DFS) is a major medico-social problem facing public health services. One of its important aspectsis high cost of the treatment. In connection with this, not only medical but also economic issues pertinent to DFS have recently been widely discussedin different countries. Clinico-economic analysis of the use of new medicinal products, therapeutic modalities, and established medical technologiesis of primary importance for making decisions concerning allocation of available financial resources. The present review of foreign publications focuseson the studies providing additional arguments in favour of modern efficacious methods for the management of DFS. The review is intended to motivateclinicians and health officials to revise current approaches to the treatment of DFS patients in this country.

Cost-of-Illness Analysis of Type 2 Diabetes Mellitus in the Russian Federation: Results from Russian multicenter observational pharmacoepidemiologic study of diabetes care for patients with type 2 diabetes mellitus (FORSIGHT-Т2DM)

Обоснование . Анализ стоимости болезни является основой для принятия решений о распределении финансовых ресурсов при оказании специализированной медицинской помощи в современной системе здравоохранения. Учитывая широкую распространенность сахарного диабета 2 типа (СД2), актуальной задачей является расчет общих (прямых и непрямых) затрат на лечение данного заболеванияв Российской Федерации (РФ). Цель . Провести анализ болезни с учетом общих затрат на лечение СД2 в зависимости от наличия осложнений и сопутствующих заболеваний. Материалы и методы . Расчет общих затрат на лечение СД2 проведен на основании данных, полученных в Российском многоцентровом наблюдательном исследовании «ФармакОэпидемиологические и клинико-экономические аспекты совеРшенСтвовАния организации медицинскоЙ помощи больным Сахарным Диабетом 2 Типа в Российской Федерации (ФОРСАЙТ-СД2)». Информация о каждом пациенте была получена из первичной медицинской документации и при анкетировании пациентов. Общие затраты рассчитывались как сумма прямых медицинских затрат, прямых немедицинских затрат и непрямых затрат. Результаты . В окончательный анализ включены 2014 больных СД2 из 45 городов РФ. Общие прямые медицинские затраты на лечение СД2, его осложнений и сопутствующих заболеваний на 1 пациента в год составили 105 337 руб. (

Comparative pharmacoepidemiological study of antihyperglycemic drugs utilization by patients with type 2 diabetes mellitus in Moscow

2742), прямые немедицинские затраты – 24 518 руб. (

Development of metabolic syndrome at a young age as a manifestation of familial partial lipodystrophy type 3 (PPARG mutation): the first description of its clinical case in Russia

638), а непрямые затраты – 149 754 руб. (

Clinical and economic analysis of the modern strategies for treating metabolic syndrome

3898). Общая стоимость лечения СД2 в РФ в 2014 г. составила 279 609 руб. (

Analysis of epidemiological indices of type 2 diabetes mellitus in the adult population of Moscow

7278) на 1 пациента в год. Заключение . Большую часть затрат (53,5%) составляют потери Внутреннего валового продукта (ВВП) вследствие нетрудоспособности пациентов. Прямые медицинские затраты составляют 37,7% от общей стоимости болезни, из которых 57% приходится на лечение осложнений СД и сопутствующих заболеваний, тогда как на долю сахароснижающей терапии – всего 10%.

Pharmacoeconomic analysis of conservative strategy for the treatment of patients with diabetic foot syndrome in Moscow

Background. xa0A pharmaco-epidemiological study comparing the dynamics of different anti-diabetic drugs in patients with type 2 diabetes mellitus (T2DM) in Russia was conducted using data from a diabetes registry. Objective. xa0To assess and compare the frequency of the prescription of oral anti-diabetic medications (OAMs) and insulin and the average cost of anti-hyperglycaemic therapy with different OAMs in 2014 and 2011. Material and methods. xa0A retrospective cohort study was conducted using national diabetic registry data from the city of Moscow. Data for 270,073 patients (≥18 years old) with T2DM registered by 31 December 2014 were analysed using international the ATC/DDD methodology. The average indicated and actual daily dosage ratio was calculated. The cost of anti-hyperglycaemic therapy for оne person/year was calculated. Results. xa0There were no significant differences in prescribed OAMs between 2011 and 2014, despite the availability of new OAM classes (data for 2011 were published in «Diabetes mellitus», 2015, p. 32–46). The tendency to prescribe two groups of OAMs remained unchanged during the 4-year period (Metformin in 40% of patients and sulfonylurea derivatives, in combination or as a monotherapy, in 49.3%). The percentage of patients with T2DM who received insulin therapy increased from 10% in 2011 to 19.2% in 2014. The absence of a significant increase in the average cost of anti-diabetic therapy by 2014 can be explained by an increase in the prescription of different Russian generics for metformin, sulfonylurea derivatives and insulin, which were cheaper than foreign analogues by 30%–60%. Conclusions. xa0The main trends in the treatment of patients with T2DM by 2014 included less frequent combination therapy with metformin and PSM and more frequent monotherapy or combination therapy with insulin. Despite the appearance of new OAM classes in the market, the overall consumption pattern in 2014 did not exceed 5%. The average cost of anti-diabetic therapy for one patient with T2DM in 2014 in Moscow was 7,727 rubles per year.

Analysis of the factors that prevent adherence to treatment in patients with diabetes mellitus and the strategies that contribute to the improvement in adherence

Metabolic syndrome (MS) is extremely common (20%–25% of the world’s population), and its diagnostic criteria are defined and well known. It has been shown that patients who have MS are twice as likely to die from a cardiovascular complication and three times as likely to suffer from it compared with patients without MS. However, the underlying cause of MS remains to be clearly elucidated, although inherited factors, such as insulin resistance (IR), and external factors are considered to play a key role in this process. Special attention should be paid to MS in young patients, who may present the first manifestation of inherited lipodystrophy. The study describes the first known family in Russia (three clinical cases) with familial partial lipodystrophy (FPLD) type 3 caused by heterozygous p.R212Q PPARG mutation (MIM#601487). The study reports rare forms of inherited IR, such as FPLD, and contributes to a better understanding of common disorders such as MS.