The effect of empagliflozin on the development of chronic heart failure after myocardial infarction according to a 12-month prospective study

BACKGROUND: Although the positive cardiovascular effect of empagliflozin has been established, its influence on the formation of heart failure (HF) in patients with type 2 diabetes mellitus (T2D) after myocardial infarction (MI) remains unknown. AIM: To study the effect of empagliflozin on the formation of chronic HF after MI in patients having diabetes mellitus of type 2 (DM 2), according to 12-month follow-up data. MATERIALS AND METHODS: 47 patients with MI and DM 2 were included; 21 received standard therapy for MI and diabetes (group 1); 26 patients, in addition, received empagliflozin (group 2). The patients were investigated in 3 and 12 months, to assess the dynamics of glycemic control, 6-minute walk test, echocardiography. RESULTS: During postinfarction period, the 6-minute walk distance was increasing in group 1 in a lesser degree (p = 0.18) than in group 2 (49.5%, p = 0.0004). The ejection fraction got better particularly in group 2 (p = 0.002). At baseline, the proportions of patients having HF with reduced and mid-range ejection fraction were 85.7% and 82.4% in groups 1 and 2 (p = 0.56) but in 12 months decreased to 71.4% and 29.4% (p = 0.012). In empagliflozin group diastolic function was improved in a third of the patients (p = 0.041). The pulmonary artery systolic pressure was increasing in group 1 (by 10,4%, p = 0.041) but decreasing in group 2 (by 24,0%, p = 0.019). Glycemic control was better in group 2 than in group 1. CONCLUSION: According to 12-month follow-up data, empagliflozin has a positive effect on HF formation and symptoms in patients having MI and DM 2. This effect may be based on the ability of empagliflozin to improve the state of the heart including the delay of postinfarction remodeling, the improvement of pulmonary artery hemodynamics, systolic and diastolic function, the reduction of risk of chronic HF with reduced and mid-range ejection fraction

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

Kriterii diagnoza sakharnogo diabeta i prognoz glyukoznoy intolerantnosti

Цель: Поиск дополнительных показателей, которые могут помочь оптимизировать диагностические критерии СД Материалы и методы: Обследовано 1150 пациентов (мужчин 519, женщин 631); 272 пациента с впервые (выявлены по обращению) зарегистрированным уровнем гликемии натощак >5.6 ммоль/л (капиллярная кровь) обследованы в стационаре. У них в течение 8-10 лет прослежена динамика гликемии. 878 лиц составили случайную выборку активно обследованных с применением орального глюкозотолерантного теста (ОПТ) и анкет по факторам риска СД; у 38 из них проведено исследование первой фазы секреторного ответа на глюкозный стимул с помощью предложенного нами укороченного теста. Пациенту в положении сидя пунктируют локтевую вену и производят забор крови для исследования иммунореактивного инсулина (ИРИ). После этого через ту же иглу в течение не более 3 мин вводится 40% раствор глюкозы из расчета 0.33 г/кг и немедленно после завершения введения через ту же иглу забирается кровь для определения стимулированной концентрации ИРИ. Результат теста оценивается по отношению стимулированного инсулина к базальному. Такое отношение названо индексом реактивности секреции инсулина (ИРСИ). Результаты: Полученные данные позволили предложить модифицированные критерии диагноза СД: 1) гликемия натощак >7 ммоль/л; 2) гликемия натощак > 6.1 ммоль/л при наличии семейной отягощенное? по СД или при наличии глюкозурии и симптомов осмодиуреза, или при наличии иных доказанных неблагоприятных прогностических факторов; 3) гликемия > 11.1 ммоль/л через 2 ч после пероральной нагрузки глюкозой (75 г). Третий критерий взят из международных рекомендаций без изменений. Предложенные критерии применяются в клинике более 10 лет

Znachenie glikemicheskogo kontrolya v ostrom periode infarkta miokarda u bol'nykh sakharnym diabetom 2 tipa

Риск сердечно-сосудистых заболеваний (ССЗ) и смертности от них при сахарном диабете в 2?5 раза превышает популяционный. Среди больных острым инфарктом миокарда (ОИМ) доля больных сахарным диабетом (СД) по самым консервативным оценкам составляет 20?25%, а число пациентов с ненарушенным углеводным обменом менее половины. Эти данные European Heart Survey нашли полное подтверждение в аналогичном исследовании, проведенном в Китае, которое выявило лишь 35,8% пациентов с нормальным метаболизмом глюкозы. Гипергликемия является главным проявлением СД, значение которого как фактора риска ССЗ показано во многих исследованиях. Роль этого потенциально управляемого фактора при ОИМ естественно привлекает самое пристальное внимание

The effects of structured self-monitoring of blood glucose on therapeutic effectiveness and adherence in patients with type 2 diabetes mellitus initiating insulin treatment

Aim.  To compare the efficiency of standard and structured approaches to self-monitoring of blood glucose (SMBG) in patients with type 2 diabetes mellitus (T2DM) initiating insulin treatment. Materials and Methods. This open prospective randomized clinical trial included 51 T2DM patients who initiated insulin therapy in either outpatient or inpatient setting. Subjects were randomized in standard and structured SMBG groups, the structured group used an advanced Accu-Chek 360 View protocol. Evaluation included clinical examination and laboratory testing of HbA1c levels at the beginning of the treatment and after 3 months of the follow-up period. Results. 70% of the structured self-monitoring group and 32% of the control group achieved therapeutic goals (p=0.008). Higher adherence was associated with better glycemic control in both groups ? and vice versa. However, among patients with low adherence, 73% of advanced SMBG group managed to achieve therapeutic goals vs. 19% in the control group (p=0.005). In addition, patients in the structured monitoring group gained less weight as compared to the control (1.0?2.88 kg vs. 3.2?2.56 kg; p=0.005). Conclusion. Structured SMBG commenced at the initiation of insulin therapy improves glycemic control in a greater fraction of patients, especially in those with low adherence to treatment. Structured SMBG also partially alleviates weight gain as side effect of insulin treatment

Undiagosed hypothyroidism as risk factor of statin-induced rhabdomyolysis

Dyslipidemia is a frequent condition in patients with hypothyroidism which determines possible need for statin use in treatement. However, both hypothyroidism and statin use can lead to myopathy and rhabdomyolysis so safety concerns are important for clinical decision. Current article is a review of publications, clinical guidelines and drug labels which are related to the problem of statin safety in patients with hypothyroidism. Recommendations are given for use of statin in patients with compensated and decompensated hypothyroidism based on review of data

Diabetic nephropathy and myocardial lesions in children with type 1 diabetes mellitus

Aim. To elucidate the role of diabetic nephropathy in pathogenesis of myo-cardial lesions in children with type 1 diabetes mellitus from the results of dopplerography of intrarenal vessels. Materials and methods. The study involved 39 children with DM1 (mean age 12,5?2,6) divided into 2 groups. Group 1 included 12 patients with subclinical diabetic lesions in the kidneys (hyperfiltration), group 2 and 3 comprised 21 and 6 patients with diabetic neph-ropathy (microalbuminuria 30?300 mg/day or proteinuria respectively). All patients under-went standard examination to evaluate cardiovascular and vegetative nervous function. Analysis of spectrograms obtained by dopplerography of intrarenal vessels included main renal artery (MRA), segmental (SA), interlobe (ILA), arch (AA), and interlobular (ILbA) arteries. Results. The study groups were not significantly different in terms of MRA, SA, AA, and ILA hemodynamics but, unlike healthy controls, showed a nonlinear decreasing gradient in vascular resistance from MRA toward peripheral vessels especially ILA and AA. Left ven-tricular hypertrophy with disturbed diastolic performance documented in 64% of the patients correlated with microalbuminuria (r=0,56,

Clinical and pathogenetic features of lesions of the lower extremities in patients with type 2 diabetes mellitus and chronic venous insufficiency

Comorbid chronic venous insufficiency (CVI) and type 2 diabetes mellitus (T2DM) are common, particularly in older people. The severity of DM and its complications can worsen the course of CVI and affect its management.Aim. To assess the impact of T2DM on lesions of the lower extremities in patients with CVI.Materials and methods. Eighty patients with CVI of the lower limbs were examined. Forty patients had T2DM (main group) and 40 patients did not have T2DM (control group). Physical examination, clinical and biochemical tests, ultrasound scanning of veins and arteries of the lower extremities and electroneuromyography (ENMG) of the lower extremities were performed for all patients. The state of the microvasculature was studied by laser Doppler flowmetry (LDF) for 15 patients in the main group and 15 patients in the control group.Results. T2DM exacerbated the course of CVI, which was clinically characterized by a greater severity of trophic (p = 0.0001) and oedema (p = 0.03) syndromes. Morphological changes in the venous blood flow in patients with T2DM with CVI were characterized by bilateral lesions (p = 0.03), more frequent failure of sapheno-femoral anastomosis (p = 0.02) and perforating veins of the lower leg (p = 0.0004). The pathogenesis of such complications was associated with diabetic factors, including hyperglycaemia, НbА1с &gt; 10%, duration of DM &gt; 10 years and the presence diabetic microangiopathy of the lower limbs. Diabetic macroangiopathy and polyneuropathy were associated with disruption of the morphological and functional characteristics of the venous system and the disruption of the microcirculation in the lower extremities, contributing to increased oedema and trophic changes. At the same time, the presence of diabetic neuropathy masked the symptoms of CVI due to reductions in pain (p = 0.0004).Conclusion. Diabetes exacerbates the course of CVI due to poor glycaemic control (HbA1c &gt; 10%), long duration of diabetes (&gt;10 years) and the presence of macroangiopathy in the lower extremities. Diabetic neuropathy of the lower limbs and diabetic microangiopathy aggravates the venous disease through disruption of microcirculation and increases the expression of trophic changes in the lower extremities

Prediktory vyzhivaemosti bol'nykh khronicheskoy serdechnoy nedostatochnost'yu, stradayushchikh sakharnym diabetom 2 tipa

Цель. Оценить выживаемость больных ХСН, страдающих СД 2; выявить параметры диабета, влияющие на течение и прогноз пациентов с недостаточностью кровообращения. Материалы и методы. Проведено исследование когорты дожития, которую составили 72 больных ХСН, страдающих СД 2. Судьба больных прослежена в течение 12 мес. У всех больных был собран анамнез и проведено физикальное обследование. Производилась оценка ФК ХСН. Выполнено Эхо-КГ. Исследовали уровень предсердного натрийуретического пептида (ПНУП). Результаты. Всего за 12 мес. наблюдения скончались 17 больных. Достоверно с выживаемостью связаны показатели тяжести ХСН, отражающие переносимость нагрузки (функциональный класс), клиническую характеристику (ШОКС) и нейрогуморальную активацию (ПНУП). Уровень ПНУП, более чем в 4 раза превышающий норму (т.е. более 8000 фмоль/мл), явился мощным предиктором неблагоприятного исхода в течение одного года. В группе выживших больные со ?стажем? СД более 10 лет составили 43% против 76% в группе скончавшихся. В группе больных с уровнем НвА1с менее 6,5% в половине случаев отмечались признаки хронической почечной недостаточности. При ХПН снижается активность почечной инсулиназы. достоверно на выживаемость оказывали влияние тяжесть ХСН и наличие уремической стадии диабетической нефропатии. На каждый балл увеличения ШОКС риск смерти в течение года возрастает на 25%. Наличие ХПН увеличивает риск смерти в 3 раза. Выводы. Почти 1/4 часть больных ХСН, страдающих СД 2, погибает в течение года. Существенное влияние на выживаемость оказывает исходная тяжесть ХСН. Наибольшее значение для прогноза среди характеристик СД 2 имеет диабетическая нефропатия. Ухудшение выживаемости отмечено уже на стадии микроальбуминурии. При наличии уремии риск смерти возрастает в 3 раза. Для быстрой оценки риска смерти в течение года можно ориентироваться на ШОКС и на наличие признаков ХПН. Для улучшения прогноза больных ХСН, страдающих СД 2, необходимо особое внимание уделять профилактике, ранней диагностике и лечению диабетического поражения почек

Glycemic control on development of chronic heart failure in patients with type 2 diabetes mellitus

Aims. To assess contribution of therapeutic training, blood glucose self-monitoring and general improvement of glycemic control on development ofchronic heart failure (CHF) in patients with type 2 diabetes mellitus (T2DM). Materials and methods. We conducted a prospective, open-label, non-controlled before/after study. 80 patients with T2DM took part in this trialafter initial hospitalization for decompensation of both CHF and diabetes (НbА1с>=8.0%). Therapeutic training as well as provision of tools and consumablesfor self-monitoring was arranged for all patients. Therapeutic goal was set to lowering НbА1с for?1% by the end of 12 months of follow-up. Results. We observed lowering of НbА1с values from 9.3% [8,4-10,6] to 8.8% [7,6-10,0] (