63 research outputs found

    Results of a clinical trial of the efficacy and safety of vildagliptin and metformin fixed combination in real clinical practice in Russia (MASTER study)

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    BACKGRAUND: The widespread prevalence of type 2 diabetes mellitus (T2DM), high mortality and disability of such patients are the reason for the constant active search for effective approaches to hypoglycemic therapy. Recent years have been marked by a change in the strategy for treatment initiation of T2DM. In clinical studies, evidence has been obtained about the benefits of prescribing combination therapy from the time of diagnosis. It seems important to study this treatment option also in real clinical practice.AIMS: To evaluate the effectiveness and safety of the initiation with Galvus Met® as compared with any other combination therapy approaches used in everyday clinical practice.MATERIALS AND METHODS: multicenter prospective observational study in 15 regions of Russia lasting 6 months. Patients were included in the study after the endocrinologist made a decision on the appointment of therapy. Of the men and women over 18 years of age with first diagnosed or previously untreated type 2 diabetes and a level of glycated hemoglobin >7.5%, two groups were formed. The first group included patients who received vildagliptin + metformin (Galvus Met®) in a fixed dose of 50/1000 mg, n=729, the second — another double combination (with the exception of insulin and GLP-1), n=669. The primary endpoint was defined as the proportion of patients (%) who achieved the level of HbA1c <7.0% without proven hypoglycemia at the end of the observation. The NHPQ questionnaire was used to assess the frequency of hypoglycemia.RESULTS: 1385 patients completed the study. For the other combination therapy group, metformin and sulfonylurea derivatives were most often selected (66.5%). In the Galvus Met® group, 68.7% of patients achieved an HbA1c level of <7.0% without proven hypoglycemia, which is significantly better compared to the group of other combinations (40.7%, p <0.001). Galvus Met® therapy contributed to a significantly greater decrease in HbA1c levels by the end of the study compared to other combinations (delta HbA1c -1.6 ± 0.8% versus -1.4 ± 0.9%, p <0.001). In the same group, the average level of HbA1c reached 6.7 ± 0.6% by the end of the study versus 7.1 ± 0.8% in the comparison group, p <0.001. In the Galvus Met® group, body weight decreased by 3.2 ± 3.9 kg, and in the comparison group by 1.3 ± 4.8 kg, p <0.001. The frequency of hypoglycemia episodes in the Galvus Met® group by the end of the study was significantly lower than in the comparison group: 0.8 ± 0.7 episodes per person, versus 1.4 ± 0.8, p = 0.037. In the Galvus Met® group, there were significantly fewer adverse events (4.9% versus 17.7%, p <0.001).CONCLUSIONS: In real clinical practice, Galvus Met® starting therapy has shown better efficacy and safety in terms of achieving glycemic control, HbA1c dynamics, effects on body weight, the frequency of hypoglycemic conditions compared with other combined oral hypoglycemic therapy

    Clinical characteristics of patients with COVID-19 depending on the treatment received and the presence of type 2 diabetes mellitus

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    BACKGROUND. Type 2 diabetes mellitus (T2DM) is an independent risk factor for adverse clinical outcomes in patients with Covid-19. There is currently insufficient data evaluating the efficacy and safety of drugs for the treatment of COVID-19, especially in patients with T2DM.AIM. The aim of study was to identify an associative relationship between the drugs used and the clinical outcomes of patients with Covid-19 and T2DM.MATERIALS AND METHODS. A retrospective analysis of the clinical outcomes of 1753 patients with COVID-19 who were hospitalized to the redesignated departments of multidisciplinary city clinical hospital in the period from 23.03.2020 to 01.06.2020.RESULTS. The total number of patients is 1,753, of which 311 (17.7%) are patients with DM2. 92.6% of patients received treatment for COVID-19. At the same time, 91.4% of patients received antibiotics (a/b), 61.5% — bronchodilators, 56.6% — injectable anticoagulants (a/c), 45.2% — hydroxychloroquine, 6.3% — antiviral drugs, 5.4% — oral a/c, 4.6% — glucocorticosteroids (GCS), 1.9% — Tocilizumab.Decrease of risk of death among patients with COVID-19 was as the therapy of a/b (OR 0.07, 95% CI 0.05–0.11, p<0.05), bronchodilators (OR 0.12, 95% CI 0.08–0.18, p<0.05) and injection a/c (OR 0.47, 95% CI 0.34–0.67, p<0.05). At the same time, among patients with DM2, compared with patients without DM2, there was a more pronounced reduction in the risk of death during injectable a/c therapy: among patients with DM2, the risk of death decreased by 2.6 times (OR 0.39, 95% CI 0.21–0.73, p<0.05), among patients without DM2 — by 2.1 times (OR 0.47, 95% CI 0.31–0.71, p<0.05). Antiviral drugs was associated with an increased chance of death among patients without DM2 (OR 2.64, 95% CI 1.44–4.86, p<0.05) and among patients with DM2 (OR 4.98, 95% CI 2.11–11.75, p<0.05).CONCLUSION. A significant decrease of the risk of death among patients with COVID-19 was as the therapy of a/b, bronchodilators, and injectable a/c. An increase of the risk of death was observed during therapy with antiviral drugs

    Real World Effectiveness of fixed combination of glargine 100 U/ml and lixisenatide therapy in outpatients with Type 2 Diabetes: A Retrospective Cohort Study SOLO

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    Background: The effectiveness and safety of a fixed combination of insulin glargine 100 ME/ml and lixisenatide for treatment of patients with type 2 diabetes (T2DM) has been demonstrated in randomized clinical trials, but there are still not enough data of it`s usage of it real clinical practice.Aim: To describe the baseline characteristics of patients with T2DM who started treatment with a fixed ratio combination of insulin glargine 100 ME/ml and lixisenatide in the period from November 2018 to July 2020, and to evaluate the effectiveness of using fixed combination of insulin glargine 100 ME/ml and lixisenatide in for 6–12 months of therapy in a real outpatient practice.Materials and methods: SOLO was a retrospective cohort multicentre study conducted in Russia, Moscow. Adults (≥18 years) with T2DM and HbA1c≥7% in case of availability of medical records during ≥180 days before and ≥1 HbA1c level during 150–210 days after start of treatment with Soliqua SoloStar® were eligible.Results: A total of 383 people with T2DM were included. Baseline characteristics were the following (mean±SD): age 59.9±8.3 years; BMI 36.4±6.3 kg/m2; proportion of patients with BMI≥35 kg/m2 — 52.2%; HbA1c 9.14±1.08%. 65% of patients received oral antidiabetic drugs (OAD) before start of treatment with fixed combination of insulin glargine 100 ME/ml and lixisenatide ; 31.3% of patients were switched from combination of OAD with basal insulin, 1.04% of patients received other therapy (GLP-1 RA, basal-bolus insulin treatment, basal insulin monotherapy), and 2.61% of patients did not receive any hypoglycemic therapy. HbA1c level was 7.78±0.8% after 6 months of treatment and 7.4±0.61% after 12 months. There was a significant decrease of body weight from the baseline value 101.62±20.64 kg by 1.96±4.03 kg at month 6 and by 3.13±4.71 kg at month 12 (p<0.001) Overall, 4 patients (1.04%) reported symptomatic hypoglycemia (glycemia ≤3.9 mmol/L); no episodes of severe hypoglycemia were registered.Conclusion: In a real-life setting in Russia, initiation of a fixed combination of insulin glargine 100 ME/ ml and lixisenatide in people with T2DM uncontrolled on OADs or combination of OADs with basal insulin resulted resulted in an improved glycemic control and body weight change with low risk of hypoglycemia compared to baselin

    Influence of type 2 sodium-glucose co-transporter inhibitors (dapagliflozin) on the indicators of total mortality in patients with type 2 diabetes (CARDIA-MOS study, Moscow)

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    BACKGROUND: The widespread use in clinical practice of drugs with cardio- and nephroprotective properties, in particular, sodium-glucose cotransporter type 2 inhibitors (SGLT2i), is based on the results of large-scale international randomized trials. Meanwhile, there are no data demonstrating the possibility of the influence of these drugs on mortality rates in real clinical practice in Russian patients. To study this issue, a CARDIA-MOS study was conducted on a population of patients with type 2 diabetes (T2DM) in Moscow.AIM: To study the effect of SGLT2i on the total mortality of patients with T2DM in Moscow.MATERIALS AND METHODS: To assess the frequency of different outcomes, two samples of patients were formed according to predetermined criteria: 1) patients who started therapy with SGLT2i (dapagliflozin) in 2017; 2) a control group of patients corresponding to the main group in terms of key indicators: age, duration of T2DM, presence of cardiovascular diseases, use of insulin therapy, HbA1c level.RESULTS: Firstly, an analysis of the data of 499 patients who started treatment with dapagliflozin in 2017, as well as 499 patients in the control group (n = 998) was made. The baseline characteristics of the patients were generally comparable. Pre-study SBP and HbA1c were worse in the dapagliflozin group. The use of dapagliflozin was associated with a 39% reduction in the relative risk of death from all causes (RR 0.614, 95% CI 0.417–0.903, p = 0.013), led to a decrease in HbA1c levels by 0.8% (from 8.5 to 7.7%, p<0.001) for 48 months. observations. The safety profile of dapagliflozin was comparable to that of the control groupCONCLUSION: The use of dapagliflozin in the treatment of patients with T2DM can reduce overall mortality and improve glycemic control

    Possibilities of application a fixed combination of alogliptin and pioglitazone for type 2 diabetes mellitus treatment

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    Hyperglycemia in T2DM is based on three main mechanisms: insulin resistance, progressive β-cell dysfunction, and excess glucose production by the liver.The onset of T2DM is usually preceded by a long period of insulin resistance. Prescribing sugar drugs that affect different links of pathogenesis, reducing a steady decrease in glycemia. To date, in clinical practice, various combinations of hypoglycemic drugs are used, the choice of which is determined by the characteristics of the course of diabetes in the patient, the presence of concomitant diseases and complications of diabetes, as well as the dominant clinical problem. This resolution provides an expert council opinion on the feasibility of using a combination of alogliptin and pioglitazone in patients with type 2 diabetes

    The advisory board resolution on the use of sodium-glucose cotransporter 2 inhibitors and glucagon-like peptide 1 receptor agonists in type 2 diabetes

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    Type 2 diabetes is characterized by increasing incidence and prevalence all-over the world. Current therapeutic management of type 2 diabetes is complex and is based not only on glycemic control, but also on cardiovascular and renal risks reduction. In previous years the use of sodium-glucose cotransporter 2 inhibitors (SGLT2i) and glucagon-like peptide 1 receptor agonists (GLP-1 RA) increased in Russian Federation. Some manufacturers of the most widely used GLP-1 RA reported the supply decline in several countries. On Advisory board with participation of the Russian Endocrinology Association members the topics of SGLT2i and GLP-1 RA use in type 2 diabetes were discussed. The experts made conclusion that the decrease in access to GLP-1 RA does not pose serious risk for treatment of type 2 diabetes patients. SGLT2i show benefits in risk reduction of HF and CKD progression compering to GLP-1 RA, and in general show comparable efficacy in risk reduction of ACVD outcomes.  SGLT2i show less glycemic efficacy in comparison with GLP-1 RA, and their replacement may need adding antidiabetic agents from other groups

    Pancreatic exocrine insufficiency in diabetes mellitus

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    Diabetes is disease of both the endo- and exocrine parts of the pancreas. Pancreatic exocrine insufficiency (PEI) can occur in every 2–3 patients with diabetes and affect not only the quality, but also life expectancy. At the same time, the diagnosis and treatment of PEI is not getting enough attention. The endocrinologist, as the main specialist leading patients with diabetes, can diagnose and treat patients with pancreatic exocrine insufficiency and diabetes using adequate doses of pancreatic enzyme replacement therapy (PERT)

    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»

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    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.)

    ХИРУРГИЧЕСКОЕ ЛЕЧЕНИЕ ДИАБЕТИЧЕСКОЙ ОСТЕОАРТРОПАТИИ

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    The article presents clinical examples of surgical treatment of diabetic osteoarthropathy. In both clinical cases, the talipes and plantar ulcerous defects became a significant factor of the threatening high ablation, which was avoided. Restoration of the support function of the foot and absence of recurrent plantar ulcerous defects in the long term is the result of a multidisciplinary team approach to the treatment of these patients. An ambulatory patient is assigned a package of therapeutic measures to prepare for the surgery. After the intervention the patient is compulsory for outpatient treatment in diabetic foot department for further monitoring and rehabilitation. Reconstructive surgery on the foot in patients with diabetic osteoarthropathy under the joint treatment of the patient by the team of specialists (endocrinologist, surgeon, orthopedist) leads to the restoration of the support function of the foot, which enables a full adaptation to the patient's daily life.В статье представлены клинические примеры хирургического лечения диабетической остеоартропатии. В обоих клинических случаях наличие выраженной деформации стоп и плантарные язвенные дефекты являлись существенными факторами угрожающей высокой ампутации, которой удалось избежать. Восстановление опорной функции стопы и отсутствие рецидивов плантарных язвенных дефектов в течение длительного периода является результатом междисциплинарного командного подхода к ведению данной категории больных. В амбулаторном режиме пациенту назначается комплекс лечебных мероприятий для подготовки к операции. После вмешательства больной в обязательном порядке направляется на амбулаторное лечение в отделение диабетической стопы для дальнейшего мониторинга и реабилитации. Реконструктивные операции на стопе у больных с диабетической остеоартропатией при совместном ведении пациента командой специалистов (эндокринолог, хирург, ортопед) приводят к восстановлению опорной функции стопы, что дает возможность полноценной адаптации больного к повседневной жизни

    Междисциплинарный подход к ведению нейропатической формы синдрома диабетической стопы. Роль ортопеда

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    The article presents the experience of an interdisciplinary approach to the management of diabetic foot syndrome using the example of treating a patient with a neuropathic form, which manifests itself as a chronic wound of the foot plantar surface.В статье представлен опыт междисциплинарного подхода к ведению синдрома диабетической стопы на примере лечения пациента с нейропатической формой, проявляющейся хронической раной подошвенной поверхности стопы
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