The dynamics of the main epidemiological indicators among living in Moscow patients with diabetes mellitus (2013–2018)

BACKGROUND: State Register of Diabetes Mellitus (SRDM) plays an important role in the dynamic analysis of the epidemiological parameters that evaluate the disease itself and its complications, and also helps to analyze the quality of specialized medical care for patients. To solve modern scientific and practical problems, it is important to analyze data not only among the entire population of Russia, but also in large administrative-territorial subjects of the country. AIMS: To Study the dynamics of the main epidemiological indicators (values) among patients with type 1 diabetes mellitus (DM1) and type 2 diabetes mellitus (DM2) living in Moscow for the period from 2013 to 2018 according to the State Register of Diabetes Mellitus (SRDM). MATERIALS AND METHODS: The analysis of Moscow region of the SRDM database was conducted. According to it there were registered 345.1 thousand patients with diabetes by 01.01.2019. RESULTS: During the period from 2013 to 2018 the total number of patients with DM increased up 9.8% (from 314.4 thousand to 345.1 thousand people). DM2 accounts for 94% of the total number of patients. According to SRDM the prevalence of DM1 on 100 thousand population has grown up 6.9% (from 152.2 in 2013 to 162.7 in 2018); DM2 – by 9.6% (from 2864.7 in 2013 to 3139.4 in 2018). The incidence of DM1 per 100 thousand people decreased down to 6.4% (from 4.7 in 2013 to 4.4% in 2018); DM2 – grew up 4.3% (from 198.1 in 2002, to 206.6 in 2018). Throughout the study period the incidence of DM2 was higher among women, while the opposite trend was observed among women with DM1. The mortality among people with DM1 in 2018 was 1.6 per 100 thousand among adult population (in 2017 it was 1.7); among patients with DM2 the mortality was 56.6 people per 100 thousand among adult population (in 2017 it was 65.6). The first place among the direct causes of death among patients with DM1 and DM2 in 2018 was occupied by cardiovascular diseases (57.5% and 67.9%, respectively), the second place – oncological diseases (9.9% and 12.2%). CONCLUSIONS: The results of the epidemiological analysis showed that since 2013 in Moscow there has been an increase in the prevalence of diabetes, against the background of stable indicators of incidence (except for the organizational period of adapting to the new online data entry system of SRDM). The leading causes of death of patients with diabetes are cardiovascular and oncological diseases

Resolution on the results of the first working meeting of the scientific advisory board «Actual problems of glycemic variability as a new criterion of glycemic control and safety of diabetes therapy»

The Scientific Advisory Board, chaired by Professor G. R. Galstyan (cochair - A.V. Zilov), met in Moscow on 19 June 2018 to discuss the possibilities of improving the results of diabetes mellitus (DM) treatment by considering glycaemic variability (GV) as an additional criterion for effective glycaemic control (especially in patients receiving insulin therapy) and as one of the goals of treatment in patients with unstable glycaemia. The purpose of the working meeting was to develop a strategy for the introduction of GV as a predictor and as an additional criterion for assessing the effectiveness and safety of hypoglycaemic therapy to improve the pharmacotherapy of diabetes and reduce cardiovascular and total mortality. The aims of the working meeting were to conduct a comprehensive data analysis of the relationship between GV and hypoglycaemia; to gather and analyse published data and the experience of decrease in GV and improved outcomes of diabetes against the background of different types of insulin therapy; to compare existing methods of glycaemia monitoring and GV assessment and examine their validity and availability in real practice in the context of limited budget and to analyse the informativeness and clinical and prognostic significance of various parameters of GV assessment and to determine their reasonable ‘minimum’ for a comprehensive assessment of GV as a criterion for evaluating the effectiveness of DM treatment and the predictors of negative diabetes outcomes. The following reports were presented during the discussion: ‘Glycemic variability: clinical and prognostic value. Types of glycemic variability’ (Candidate of Medical Sciences, assistant Professor Zilov A.V.); ‘Methods of assessment of variability of glycemia in clinical trials and routine practice’ (PhD, Professor Markova T. N.); ‘Current international and national recommendations on glycemic monitoring’ (PhD, Professor Galstyan G. R.) and ‘Peculiarities of glycemic variability and its evaluation among children and adolescents’ (Candidate of Medical Sciences Vitebskaya A.V.)

What are new opportunities for clinical practice the VERIFY study opens and which values for native diabetes patients? Joint conclusion on the advisory board results. November 6, 2019

According to key diabetic studies, the early use of metformin glucose lowering therapy is associated with a reduced risk of developing micro- and, in the long term, 10-year follow-up, macrovascular complications and cardiovascular mortality. Short-term studies results on combined glucose lowering therapy with metformin suggests that combination therapy can have several advantages on the one side from the effectiveness of glycemic control and on another side from positive effect on the development of complications of type 2 diabetes. The question of the start time of combined hypoglycemic therapy remains open. According to the results of recent large-scale studies, real world evidence data, careful glycemic control during the first year from the moment of diagnosis of type 2 diabetes is crucial for further management of the disease and slow the progression of complications. However, due to the fact that the clinical benefits of early combination therapy were not demonstrated in randomized clinical trials, this approach, despite the theoretical background, was not recommended for widespread use in international guidelines for the treatment diabetes patients. Russian algorithms on the treatment diabetes patients recommend combined glucose lowering therapy at the start of treatment at a HbA1c level of 1% higher than the target. A 5-year VERIFY study results were demonstrated long-term sustained glycemic control in combination with vildagliptin + metformin prescribed for native diabetes patients with relatively low HbA1c values, as well as the advantages of this approach in comparison with the standard strategy for phased intensification of monotherapy. The results of the VERIFY study provided a wealth of information to discuss early treatment intensification, the clinical benefits of this approach and a possible review of the treatment strategy for native diabetes patients

Diabetes mellitus type 2 in adults

Public organization “Russian Association of Endocrinologists”. Clinical guidelines.&nbsp

Diabetes mellitus type 1 in adults

Public organization “Russian Association of Endocrinologists”. Clinical guidlines

Design and baseline characteristics of the finerenone in reducing cardiovascular mortality and morbidity in diabetic kidney disease trial

Background: Among people with diabetes, those with kidney disease have exceptionally high rates of cardiovascular (CV) morbidity and mortality and progression of their underlying kidney disease. Finerenone is a novel, nonsteroidal, selective mineralocorticoid receptor antagonist that has shown to reduce albuminuria in type 2 diabetes (T2D) patients with chronic kidney disease (CKD) while revealing only a low risk of hyperkalemia. However, the effect of finerenone on CV and renal outcomes has not yet been investigated in long-term trials. Patients and Methods: The Finerenone in Reducing CV Mortality and Morbidity in Diabetic Kidney Disease (FIGARO-DKD) trial aims to assess the efficacy and safety of finerenone compared to placebo at reducing clinically important CV and renal outcomes in T2D patients with CKD. FIGARO-DKD is a randomized, double-blind, placebo-controlled, parallel-group, event-driven trial running in 47 countries with an expected duration of approximately 6 years. FIGARO-DKD randomized 7,437 patients with an estimated glomerular filtration rate >= 25 mL/min/1.73 m(2) and albuminuria (urinary albumin-to-creatinine ratio >= 30 to <= 5,000 mg/g). The study has at least 90% power to detect a 20% reduction in the risk of the primary outcome (overall two-sided significance level alpha = 0.05), the composite of time to first occurrence of CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure. Conclusions: FIGARO-DKD will determine whether an optimally treated cohort of T2D patients with CKD at high risk of CV and renal events will experience cardiorenal benefits with the addition of finerenone to their treatment regimen. Trial Registration: EudraCT number: 2015-000950-39; ClinicalTrials.gov identifier: NCT02545049

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

Background. A 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. To 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. A 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. There 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. The 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