Возможности клинического применения препарата эзетимиба Отрио (АО "АКРИХИН", Россия) у пациентов высокого и очень высокого сердечно-сосудистого риска, не достигших целевых значений показателей липидного обмена. Заключение Совета экспертов

This Conclusion of the Board of experts is devoted to the analysis of the evidence base, the position in modern clinical guidelines, the efficacy and safety analysis as well as the options of combined therapy with statins and ezetimibe (Otrio, JSC “AKRIKHIN”) in various categories of patients in routine clinical practice in theRussian Federation. Cardiovascular diseases (CVD) continue to lead in the structure of morbidity and mortality inRussia. Hypercholesterolemia is one of the main modifiable risk factors for CVD. Administration of HMGCo-A-reductase inhibitors (statins) remains the basis for the prevention and treatment of the main complications of atherosclerosis, but the achievement of target levels of LDL-C on of statin monotherapy in Russian practice among different categories of risk does not exceed 50%. Proportion of patients (up to 12%) does not tolerate statin therapy, which requires the search for alternative therapies. To optimize the control of the level of LDL-C, combination therapy with statins and ezetimibe is used. Ezetimibe is an effective lipid-lowering drug, an inhibitor of intestinal absorption of cholesterol, which was investigated in many international and Russian studies, the results of which have demonstrated good tolerability, safety and efficacy (reduction of LDL-C levels by 18% in monotherapy). It was noted that the combined therapy with low/medium doses of statins and ezetimibe effectively reduces the level of LDL-C by 44-53%, which is comparable to the effect of high doses of statins and reduces CV risk in patients with CKD and ACS. Otrio (INN Ezetimib) tablets 10 mg ( JSC “AKRIKHIN”,Russia) has demonstrated bioequivalence to the original drug Ezetrol tablets 10 mg (Schering-plough Labo N. V,Belgium). Broad use of a new generic product Otrio in combination with different statins will significantly increase the frequency of achievement of target lipid levels in patients with high and very high CV risk, including patients with chronic renal failure, type 2 diabetes and in patients with high hypercholesterolemia (LDL-C > 5 mmol/l) and, ultimately, reduce the burden of CV disease and mortality in Russia.Настоящее Заключение Совета экспертов посвящено анализу доказательной базы, месту в современных клинических рекомендациях, анализу эффективности и безопасности, а также возможностям комбинированной терапии статинами и препаратом эзетимиба (Отрио, АО «АКРИХИН») у различных категорий пациентов в повседневной клинической практике в Российской Федерации. Сердечно-сосудистые заболевания (ССЗ) продолжают лидировать в структуре заболеваемости и смертности в РФ. Одним из главных модифицируемых факторов риска ССЗ является гиперхолестеринемия. Основа профилактики и лечения основных осложнений атеросклероза - терапия ингибиторами ГМГ-КоА-редуктазы (статинами), однако достижение целевых уровней ХС ЛНП на фоне монотерапии статинами в российской практике в различных категориях риска не превышает 50%. Часть больных (до 12%) не переносит терапию статинами, что требует поиска альтернативных схем терапии. Для оптимизации контроля уровня холестерина ХС ЛНП применяют комбинированную терапию статинами и эзетимибом. Эзетимиб - эффективный гиполипидемический препарат, ингибитор кишечной абсорбции ХС, хорошо изученный в международных и российских исследованиях, результаты которых показали хорошую переносимость, безопасность и эффективность (снижение уровня ХС ЛНП на 18% в монотерапии). Отмечено, что комбинированная терапия низкими/средними дозами статинов и эзетимибом за счет двух синергичных механизмов действия (концепция «двойного ингибирования» ХС) позволяет весьма эффективно снижать уровень ХС ЛНП на 44-53%, что сопоставимо с эффектом высоких доз статинов, а также уменьшает сердечно-сосудистый риск у больных с хронической почечной недостаточностью (ХПН) и ОКС. Препарат Отрио (МНН Эзетимиб), таблетки 10 мг (АО «АКРИХИН», Россия) биоэквивалентен оригинальному препарату Эзетрол®, таблетки 10 мг (Шеринг-Плау Лабо Н В, Бельгия). Широкое применение генерического препарата Отрио в комбинации с различными статинами позволит значительно увеличить частоту достижения целевых уровней липидов у больных высокого и очень высокого сердечно-сосудистого риска, в том числе у пациентов с ХПН, СД 2 типа и у лиц с высокой гиперхолестеринемией (ХС ЛНП >5 ммоль/л) и, в тем самым, уменьшить бремя сердечно-сосудистых заболеваний и смертности в РФ

Possibilities of clinical use of ezetimibe Otrio (JSC "AKRIKHIN", Russia) in patients with high and very high cardiovascular risk who have not reached the target values of lipid metabolism. Conclusion of the Board of experts

This Conclusion of the Board of experts is devoted to the analysis of the evidence base, the position in modern clinical guidelines, the efficacy and safety analysis as well as the options of combined therapy with statins and ezetimibe (Otrio, JSC "AKRIKHIN") in various categories of patients in routine clinical practice in theRussian Federation. Cardiovascular diseases (CVD) continue to lead in the structure of morbidity and mortality inRussia. Hypercholesterolemia is one of the main modifiable risk factors for CVD. Administration of HMGCo-A-reductase inhibitors (statins) remains the basis for the prevention and treatment of the main complications of atherosclerosis, but the achievement of target levels of LDL-C on of statin monotherapy in Russian practice among different categories of risk does not exceed 50%. Proportion of patients (up to 12%) does not tolerate statin therapy, which requires the search for alternative therapies. To optimize the control of the level of LDL-C, combination therapy with statins and ezetimibe is used. Ezetimibe is an effective lipid-lowering drug, an inhibitor of intestinal absorption of cholesterol, which was investigated in many international and Russian studies, the results of which have demonstrated good tolerability, safety and efficacy (reduction of LDL-C levels by 18% in monotherapy). It was noted that the combined therapy with low/medium doses of statins and ezetimibe effectively reduces the level of LDL-C by 44-53%, which is comparable to the effect of high doses of statins and reduces CV risk in patients with CKD and ACS. Otrio (INN Ezetimib) tablets 10 mg ( JSC "AKRIKHIN",Russia) has demonstrated bioequivalence to the original drug Ezetrol tablets 10 mg (Schering-plough Labo N. V,Belgium). Broad use of a new generic product Otrio in combination with different statins will significantly increase the frequency of achievement of target lipid levels in patients with high and very high CV risk, including patients with chronic renal failure, type 2 diabetes and in patients with high hypercholesterolemia (LDL-C > 5 mmol/l) and, ultimately, reduce the burden of CV disease and mortality in Russia

Position paper. The role of iron deficiency in patients with chronic heart failure and current corrective approaches

Further to the discussions, a position paper with the following main provisions was elaborated: 1. Iron Deficiency (ID) must be regarded as an independent clinically significant concomitant condition, with the prevalence reaching 50% among Chronic Heart Failure (CHF) patients in Russia. 2. According to observation studies iron deficiency in patients with CHF adversely affects functional performance and is associated with increased hospitalization rates and mortality. 3. ID must be excluded in all CHF patients, regardless of haemoglobin levels; the severity of ID should be evaluated. Blood ferritin concentration and transferrin saturation (TSAT, transferrin saturation coefficient) are currently optimal parameters for defining ID. 4. According to current data, therapy aimed only at increasing blood haemoglobin concentrations does not seem to have advantages in influencing the prognosis and clinical manifestations of CHF, while the elimination of ID in CHF patients leads to significant clinical benefits even in the absence of anaemia. 5. According to recently available data (the results of Randomized Clinical Trials, RCTs), the intravenous use of ferric carboxymaltose should be considered the most consistent approach for the treatment of ID in CHF patients. © 2020 Seoul National University. All rights reserved

Iron deficiency in Russia heart failure patients. Observational cross-sectional multicenter study

Aim    To evaluate the prevalence of iron deficiency (ID) in Russian patients with heart failure (HF).Material and methods    Iron metabolism variables were studied in 498 (198 women, 300 men) patients with HF. Data were evaluated at admission for HF (97 %) or during an outpatient visit (3 %). ID was determined according to the European Society of Cardiology Guidelines.Results    83.1 % of patients had ID; only 43.5 % of patients with ID had anemia. Patients with ID were older: 70.0 [63.0;79.0] vs. 66.0 years [57.0;75.2] (p=0.009). The number of patients with ID increased in parallel with the increase in HF functional class (FC). Among patients with ID, fewer people were past or current alcohol users (p=0.002), and a greater number of patients had atrial fibrillation (60.1 vs. 45.2 %, p=0.016). A multiple logistic regression showed that more severe HF (HF FC) was associated with a higher incidence of ID detection, whereas past alcohol use was associated with less pronounced ID. An increase in N-terminal pro-brain natriuretic peptide (NT-proBNP) by 100 pg/ml was associated with an increased likelihood of ID (odds ratio, 1.006, 95 % confidence interval: 1.002-1.011, p=0.0152).Conclusion    The incidence rate of HF patients is high in the Russian Federation (83.1 %). Only 43.5 % of these patients had anemia. The prevalence of ID in the study population increased with increases in HF FC and NT-proBNP