Vol 22, No 4 (2020)


What is the danger of the COVID-19 epidemic for patients with diabetes?

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Интервью с академиком РАН, доктором медицинских наук, профессором, директором Института диабета ФГБУ «Национальный медицинский исследовательский центр эндокринологии» Минздрава России Мариной Владимировной Шестаковой.
Consilium Medicum. 2020;22(4):9-10
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Pharmacoeconomic aspects of treatment with fixed combinations: dipeptidyl peptidase-4 inhibitors + metformin vs sulfonylurea + metformin in patients with type 2 diabetes: retrospective analysis of Russian national registry of diabetes registry data for 2010-2017

Bukharov K.G., Vikulova O.K., Galstyan G.R., Masienko M.S., Demura S.A., Stroylova Y.Y., Shestakova M.V.


Aim. Evaluate pharmacoeconomic aspects at the start of drug therapy with fixed combinations dipeptidyl peptidase-4 inhibitors (iDPP-4) + metformin vs fixed combinations sulfonylurea (SU) + metformin in patients with type 2 diabetes in real-world clinical practice. Materials and methods. This study utilized the data from the National Registry of Diabetes (NRD). The following inclusion criteria was used: patients who received drug therapy with fixed combinations, which had been prescribed for the first time over the period 2010-2017. Subsequently, two comparison groups were created from the pool of selected patients, comparable by gender and age, with no complications at the start of treatment. The total number of patients with T2DM, whose data had been reviewed during the study, was 36 100 patients: n=18 080 in SU + metformin group and n=18 020 in iDPP-4 + metformin group. All the patients with the given characteristics who were on continuous treatment for the said period were analyzed for HbA-, levels and BMI at the start of treatment and overtime (2018). We established as the principal clinical and economic criterion for evaluating the selected treatment models, the lack of diabetic complications (% of patients without complications in each of the studied groups). Methods used for pharmacoeconomic analysis included: cost-effectiveness analysis, budget impact analysis and cost minimization analysis. Also, based on the cost-effectiveness analysis, a cost-effectiveness ratio (CER) was calculated. Results. The rate of complications recorded in iDPP-4 + metformin group was lower than in SU + metformin group: for eye-related complications (diabetic retinopathy and cataract) it was lower by 1.9 times (2.7% vs 5.2%; p<0.01) and for cardiovascular complications - by 1.8 times (3.0% vs 5.3%; p<0.01). As for lower limb complications (diabetic foot syndrome and amputation) there was no statistically significant difference between the groups (0.7% vs 0.7%; p>0.9). Taking into account the direct medical, direct non-medical and indirect costs related to treatment of diabetic complications, the cost of iDPP-4 + metformin treatment per patient per year was 32 776 rubles, which is 35% lower than that for SU + metformin (50 122 rubles). The calculation model used in budget impact analysis demonstrated that with an increase in the proportion of patients who start treatment with iDPP-4 + metformin instead of routinely prescribed SU + metformin from 13% to 50%, and factoring in the number of naive T2DM patients, the public spending would be reduced by 166 million rubles per year, or by 832 million rubles over 5 year period. Based on the cost-effectiveness analysis, the calculated CER value for iDPP-4 + metformin was 73 079 rubles compared to 66 954 rubles for SU + metformin. The average cost of SU + metformin therapy per year was 9313 rubles vs 38 786 rubles for iDPP-4 + metformin (>316%), and following costeffectiveness analysis the difference in favor of SU + metformin was only 9%. In iDPP-4 + metformin group, the CER values were within the range from 82 459 rubles to 57 337 rubles, in SU + metformin group - 66 954 rubles. Conclusion. The performed clinical and economic analysis of NRD database showed the lower rate of micro- and macro-vascular complications in patients on fixed combinations iDPP-4 + metformin compared with patients on SU + metformin, as well as better cost-effectiveness. Among the fixed combinations iDPP-4 + metformin with equivalent clinical efficacy, the lowest cost combination is alogliptin + metformin. Key words: iDPP-4, SU, Registry of Diabetes, cost analysis, cost-effectiveness analysis, budget impact analysis, cost minimization analysis. For citation: Bukharov K.G., Vikulova O.K., Galstyan G.R. et al. Pharmacoeconomic aspects of treatment with fixed combinations: dipeptidyl peptidase-4 inhibitors + metformin vs sulfonylurea + metformin in patients with type 2 diabetes: retrospective analysis of Russian national registry of diabetes registry data for 2010-2017. Consilium Medicum. 2020; 22 (4): 18-26. DOI: 10.26442/20751753.2020.4.200106
Consilium Medicum. 2020;22(4):18-26
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Non-commercial insulin delivery closed-loop systems

Sorokin D.I., Laptev D.N.


Despite present-day development and opportunities of diabetes mellitus (DM) type 1 control achievement of disease compensation requires active participation of the patients and is observed only in 16-35% of patients. To improve effectiveness of DM type 1 control and quality of life of DM 1 patients insulin delivery closed-loop systems are being developed that regulate insulin delivery consistently to glycemia levels. At present time there are no approved commercial systems of this kind. That is why patients’ communities are trying on their own to implement this approach that was named Artificial Pancreas System Do-It-Yourself (APSDIY). APSDIY underwent no clinical trials, were not authorized for use, are developed and operated by patients themselves that requires certain technical skills. The users take full responsibility for the device use. APSDIY consists of three components: insulin pump, continuous glucose monitoring system, and mathematical algorithm. APSDIY operating principle is represented by mathematical analysis of incoming data from continuous glucose monitoring system, prognosing glycemia trend and following changes of insulin dosage for maintaining target glucose level. Results of several non-randomized studies were published that mainly show sufficient effectiveness of APSDIY use with decrease of glycated hemoglobin level, increase of time of glucose target levels maintenance, decrease pf glycemia variability, and quality of life improvement. Although there is no reliable information on its safety. The lack of financing is the main problem in randomized studies conducting. Absence of authorization for use does not allow medical practitioners to initiate treatment using insulin delivery closed-loop systems, but they should inform patients and warn them of the risks of using these systems. Despite existing limitations, the number of APSDIY users is increasing every year. Further research is necessary for APSDIY effectiveness and safety evaluation, and for determination of these systems development and use perspectives. Key words: diabetes mellitus, automated insulin delivery closed-loop system, artificial pancreas system. For citation: Sorokin D.Iu., Laptev D.N. Non-commercial insulin delivery closed-loop systems. Consilium Medicum. 2020; 22 (4): 27-30. DOI: 10.26442/20751753.2020.4.200117
Consilium Medicum. 2020;22(4):27-30
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Functional status of an elderly patient with diabetes

Dudinskaya E.N., Tkacheva O.N.


Diabetes mellitus (DM), especially type 2 DM, is one of the most relevant global pandemics and has serious medical, social and economic significance in both developed and developing countries. A steady increase in life expectancy of the world's population is accompanied by an increase in the prevalence of DM among older people. In this regard, new approaches to determining the most vulnerable categories of elderly patients with DM, new goals for controlling carbohydrate metabolism, and tactics of treating diabetes in this age group are considered. Pathophysiology, as well as signs and symptoms of diabetes in elderly patients have specific features for a number of age-related reasons. Laboratory features complicate the timely diagnosis of the disease in the elderly. The comorbidity of geriatric syndromes significantly complicates the course of DM and determines the need for knowledge not only in the field of diabetology, but also geriatrics. This article presents the features of a holistic geriatric approach to the treatment of diabetes in the elderly, the possibility of typing older patients to determine individual goals and understand the characteristics of the treatment of diabetes in elderly citizens. Key words: diabetes mellitus, geriatrics, functional status, old age, cognitive impairment, senile asthenia. For citation: Dudinskaya E.N., Tkacheva O.N. Functional status of an elderly patient with diabetes. Consilium Medicum. 2020; 22 (4): 31-35. DOI: 10.26442/20751753.2020.4.200156
Consilium Medicum. 2020;22(4):31-35
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Practical recommendations of the obesity management task force of the European Association for the Study of Obesity for the post-bariatric surgery medical management (2017) in clinical use

Volkova A.R., Semikova G.V., Dygun O.D., Fishman M.B., Mozgunova V.S.


Obesity is a common disease; it significantly increases the risk of death because of cardiovascular diseases. Bariatric surgery is an effective method of treatment, which leads to anatomical changes in the gastrointestinal tract and affects gastrointestinal hormones profile. After bariatric surgery, patients deal with new physiological conditions. Patients need to adapt to their new look and fit, to change the eating behavior. It is required to identify and eliminate complications arising from the patient's low commitment to a new lifestyle. It is important to compensate the vitamins and minerals deficiency. Adjusting of drugs dose in patients with comorbidities is necessary. Pregnant women after bariatric surgery require special attention during pregnancy. In addition, weight regain may appear, which should be prevented, and if necessary, eliminated. Thus, patients undergoing bariatric intervention require a multidisciplinary approach in the postoperative period. Practical Recommendations of the Obesity Management Task Force of the European Association for the Study of Obesity for the Post-Bariatric Surgery Medical Management (2017) in highlight these issues in detail. This article presents the translation of original recommendations by authors of Pavlov First State Medical University of Saint Petersburg. Results of Recommendations applying to clinical use on obese patients after various types of bariatric surgery have published down. Key words: obesity, bariatric surgery, weight regain. For citation: Volkova A.R., Semikova G.V., Dygun O.D. et al. Practical recommendations of the obesity management task force of the European Association for the Study of Obesity for the post-bariatric surgery medical management (2017) in clinical use. Consilium Medicum. 2020; 22 (4): 36-42. DOI: 10.26442/20751753.2020.4.200114
Consilium Medicum. 2020;22(4):36-42
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Paleo diet: myths and facts

Altashina M.V., Ivannikova E.V., Troshina E.A.


In recent years the paleolithic model of nutrition has gained big popularity in the world. This is due to a vast list of assumed beneficial effects of the ancient man's diet on physical health indicators. The paleo diet is proposed not only as a way to prevent various diseases (cardiovascular ones, diabetes, obesity, cancer, etc.) but also for the treatment of certain autoimmune and other disorders. However, the paleo diet is very different from the usual diet in its composition. The consequences of a long-term severe restriction in carbohydrate consumption currently remain unknown. Given the growing popularity of the paleo diet, the number of studies is increasing, in which the preventive and therapeutic properties of the ancient man's nutritional model are studied. This review highlights the data of recent clinical trials of different paleo diet options in patients with various concomitant diseases. It should be noted that to date there is no clinically reasonable data on the administration of the paleo diet as a treatment option for such serious diseases as, for example, multiple sclerosis. Despite the relatively small number of studies and the low power of the vast majority of them, it seems most likely that the paleo diet is effective primarily as a preventive option. Key words: low-carbohydrate diet, type 2 diabetes, obesity. For citation: Altashina M.V., Ivannikova E.V., Troshina E.A. Paleo diet: myths and facts. Consilium Medicum. 2020; 22 (4): 43-46. DOI: 10.26442/20751753.2020.4.200124
Consilium Medicum. 2020;22(4):43-46
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Effects of vitamin D therapy on glucose metabolism in patients with prediabetes

Andreeva A.T., Gavrilova V.I., Ustyuzhanina A.O., Bystrova A.A., Kokina M.A., Karonova T.L.


There have been an increasing number of investigations on the role of vitamin D in glucose metabolism and the possibility of type 2 diabetes prevention with cholecalciferol but the optimal doses have not been determined yet. Aim. To assess the effect of cholecalciferol therapy at various doses on glucose metabolism in patients with prediabetes. Materials and methods. The study included 70 women aged 40 to 62 years (mean age 53.5±6.4 years) with prediabetes not taking vitamin D and without diseases affecting its metabolism. Patients were randomized into two groups: group 1 (n=32) received cholecalciferol 500 IU/day, group 2 (n=38) - 4000 IU/day for three months. Anthropometric data, comorbidities, and concomitant medications were assessed. Before and after three months of cholecalciferol therapy all patients underwent a standard oral glucose tolerance test with venous blood sampling at points 0’, 60’, and 120’. Plasma glucose was evaluated by the glucose oxidase method, insulin and glucagon-like peptide 1 (GLP-1) - by enzyme-linked immunosorbent assay. The indices of insulin resistance (HOMA-IR), insulin sensitivity (ISI-0,120) and functional activity of р-cells (HOMA-B) were calculated. Glycated hemoglobin (HbA1c) was determined by ion exchange chromatography. Serum 25-hydroxycalciferol [25(OH)D] and parathyroid hormone (PTH) were evaluated by the chemiluminescent immunoassay. Results. Fifty-eight patients completed the study. Initially most women (87.9%) had vitamin D deficiency or insufficiency. After three months of cholecalciferol therapy, an increase in 25(OH)D and decrease in PTH concentration were found in both groups (p=0.01). Normal values of serum 25(OH)D were reached by 9 patients (28.1%) from group 1 (500 IU/day) and 22 patients (73.3%) from group 2 (4000 IU/day). Reduction in HbA1c (p=0.001) and plasma glucose at points 60' (p=0.04) and 120' (p=0.04), increase in insulin level at point 120' (p=0.03) and gain in HOMA-B index (25.3%) at the end of the study were observed only in patients taking 4000 IU of cholecalciferol daily. After three months of therapy in 19 women (50%) from group 2 glucose and HbA,c levels corresponded to normal values while only 2 patients (7.1%) from group 1 had these parameters within normal ranges (p=0.001). Conclusions. Treatment with 4000 IU of cholecalciferol per day for three months is associated with increase in vitamin D level and glucose metabolism improvement in women with prediabetes. Key words: prediabetes, vitamin D, glucose, insulin, 25(OH)D, cholecalciferol. For citation: Andreeva A.T., Gavrilova V.I., Ustyuzhanina A.O. et al. Effects of vitamin D therapy on glucose metabolism in patients with prediabetes. Consilium Medicum. 2020; 22 (4): 47-54. DOI: 10.26442/20751753.2020.4.200115
Consilium Medicum. 2020;22(4):47-54
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Charcot diabetic neuroosteoartropathy: review of pathology and outpatient care experience

Demina A.G., Bregovskii V.B., Karpova I.A.


Among symptoms of diabetic foot syndrome diabetic neuroosteoartropathy (Charcot foot) has a special place. Charcot foot occurrence in “diabetic foot” offices in Saint Petersburg in 2019 ranged from 0.19 to 1.68% patients. This pathology is diagnosed late in most cases that results in development of severe foot deformity until support ability of the limb is lost. Severe limb deformity and swelling in active disease stage are associated with high risk of injures, infection development and risk of amputation. The article presents essentials of epidemiology, pathogenesis, clinical presentation, and treatment of Charcot foot that are important for all medical practitioners regardless of postgraduate medical training. Results of active stage Charcot foot treatment in outpatient “diabetic foot” offices from 2018 to 2020 years are presented (n=136). Advantages of total contact cast use over removable cast walkers were found: median if treatment duration was 9 (4-28) months and 13 (6-20) months, respectively; р<0.05. Obstacles of wide use of total contact cast in these patients are characterized. Comparison of treatment results in 2010-2014 years and 2015-2020 years was performed, it was shown that frequency of immobilization refusal decreased from 49.6 to 30.9% (р<0.05), and median of immobilization duration time decreased from 9 to 7 months (р<0.05). Based on the research of experience of Charcot foot patients treatment the authors suggested organizational measures that allowed increasing patients’ compliance and improve treatment results. Key words: diabetic foot, diabetic neuroosteoartropathy, Charcot foot, diabetes mellitus. For citation: Demina A.G., Bregovskii V.B., Karpova I.A. Charcot diabetic neuroosteoartropathy: review of pathology and outpatient care experience. Consilium Medicum. 2020; 22 (4): 55-60. DOI: 10.26442/20751753.2020.4.200130
Consilium Medicum. 2020;22(4):55-60
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Diabetic foot osteomyelitis: surgical treatment versus prolonged antibacterials - point of view

Tsvetkov V.O., Kolovanova O.V., Mikayelyan L.S., Gambaryan K.U., Soloveva A.M.


Background. The current tendency to ultimate preservation of the foot in patients with diabetic foot infection has led to the mode of antibacterial bone infection treatment in contrast with more traditional radical surgery. Materials and methods. We observe the results of cure of 140 patients with diabetic foot osteomyelitis. 111 of them had the distal foot bone infection, in 29 patient middle or hindfoot bones were involved. In distal foot infection we prefer the radical resection of infected structures accompanied by short antibacterial course. In contrary, the middle or rear foot osteomyelitis required prolonged antibacterial treatment with phased bone resection. The results were observed during 12 months. Results. Radical surgical treatment has led to persistent wound healing in 98 (88.3%) cases. 4 (3.6%) of these patients required additional hospitalisation and surgery. In middle foot, talus and heel osteomyelitis the persistent wound healing was obtained in 19 (59.4%) patients. A below-knee amputation was performed in 5 (15.6%) cases of hindfoot osteomyelitis. Conclusions. The radical surgery with short antibacterial course is preferable when it will not lead to the loss of weight-bearing. The osteomyelitis of tarsus, talus and calcaneus as a rule require prolonged antibacterial treatment with careful phased bone resection. These patients should remain under permanent control due to high risk of sepsis. Key words: diabetic foot, bone infection, osteomyelitis, antibacterial treatment, bone resection, amputation. For citation: Tsvetkov V.O., Kolovanova O.V., Mikayelyan L.S. Diabetic foot osteomyelitis: surgical treatment versus prolonged antibacterials - point of view. Consilium Medicum. 2020; 22 (4): 61-65. DOI: 10.26442/20751753.2020.4.200143
Consilium Medicum. 2020;22(4):61-65
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Bisphosphonates: 50 years in clinical practice

Golounina O.O., Belaia Z.E.


Bisphosphonates (BPs) have been actively used in medicine since the late 1960s, 50 years of clinical experience testifies to their successful application in the prevention and treatment of osteoporosis, Paget's disease, in patients with bone metastases of malignant tumors. Evidence of the effectiveness and safety of this class of drugs has been obtained and confirmed by numerous studies and long-term clinical practice. The main pharmacological effect of BPs is to reduce the rate of bone remodeling with a slowdown in the phase of bone resorption. In addition, according to a number of studies, BPs may have an additional impact on the survival of patients after a hip fracture. Currently, nitrogen-containing BPs, which include alendronic, risedronic, ibandronic and zoledronic acids, are actively used in clinical practice. Serious adverse events associated with taking BPs occur quite rarely, and compliance with the instructions allows to minimize them. After the patent protection of key BPs was closed, their generics were created, which are now widely used in world practice and in the Russian Federation. In 2020, new Russian-made generics became available: Rezoviva (ibandronic acid 3 mg for intravenous administration once every 3 months) and Osteostatix (zoledronic acid 5 mg 100 ml of solution for intravenously once a year). Thus, BPs remain effective and safe for the treatment and prevention of osteoporosis, as well as for a number of other skeletal diseases. The appearance of generics of these drugs makes it possible to increase the availability of these medications for both the individual patient and the healthcare system. Key words: bisphosphonates, alendronate, risedronate, ibandronate, zoledronic acid, generics, osteoporosis, Paget's disease, bone metastases. For citation: Golounina O.O., Belaia Z.E. Bisphosphonates: 50 years in clinical practice. Consilium Medicum. 2020; 22 (4): 66-73. DOI: 10.26442/20751753.2020.4.200102
Consilium Medicum. 2020;22(4):66-73
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Hereditary medullary thyroid cancer

Nuralieva N.F., Yukina M.Y., Troshina E.A., Danilova A.V.


Medullary thyroid cancer (MTC) is a tumor originating from parafollicular C-cells and producing calcitonin. Hereditary variants consist 20-30% of all cases of MTC. Of these, 60-85% of patients have MEN (multiple endocrine neoplasia) type 2A, 5% have MEN type 2B and 10-35% have familial forms of MTC, which clinically manifest only by MTC. MTC characterized by relatively slow tumor growth and rapid onset of metastasis. Metastases primarily affect the lymph nodes of the neck and mediastinum, distant metastases can be found in the lungs, liver and bone structures. Preventive thyroidectomy is the most effective method of preventing hereditary MTC. Timely diagnosis in accordance with generally accepted recommendations for the management of nodules of the thyroid gland and individualization of treatment tactics based on genetic examination can significantly improve the prognosis of the disease. The article focuses on the management of this category of patients particularly in a patient with MEN 2B syndrome. Key words: multiple endocrine neoplasia type 2B syndrome, RET gene, medullary thyroid cancer, pheochromocytoma. For citation: Nuralieva N.F., Yukina M.Yu., Troshina E.A., Danilova A.V. Hereditary medullary thyroid cancer. Consilium Medicum. 2020; 22 (4): 74-78. DOI: 10.26442/20751753.2020.4.200118
Consilium Medicum. 2020;22(4):74-78
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