Pharmacoepidemiological and pharmacoeconomic analyses of the utilization of hypoglycaemic drugs in patients with type 2 diabetes mellitus in Moscow
Authors: Kalashnikova Marina Fedorovna , Belousov Dmitriy Yur'evich , Suntsov Yury Ivanovich , Kantemirova Maria Alexeevna , Dedov Ivan Ivanovich 
Published: June 2015

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 (HbA1c>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.