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

Persistent dyslipidemia in statin-treated patients: Russian real-world clinical practice data (Russian part of the DYSIS Study)

The high prevalence of persistent dyslipidemia in primary and specialised care patients treated with statins justifies the need to identify its reasons and develop the recommendations on the treatment optimization. At present, Russian studies focusing on the achievement of target lipid levels remain scarce, which emphasizes the importance of the problem and its further investigation. Aim. Cross-sectional epidemiological study which assessed the prevalence of persistent dyslipidemia in statin-treated patients and analysed the predictors of the achievement of target lipid levels. Material and methods. The lipid profile parameters were analysed in 1586 statin-treated out-patients with varied levels of cardiovascular risk, taking into account the type of lipid-lowering therapy and its doses. The assessment of the cardiovascular event (CVE) risk and the definition of target levels of low-density lipoprotein cholesterol (LDL-CH), as well as normal levels of triglycerides (TG) and high-density lipoprotein cholesterol (HDL-CH), was based on the clinical recommendations by the European Society of Cardiology (ESC 2007) and by the European Society of Cardiology and the European Atherosclerosis Society (ESC/EAS 2011 ). Results. The analysis based on the ESC 2007 recommendations has demonstrated that the target levels of LDL-CH (<2,5 mmol/l for high-risk patients) were not achieved in 53,5% of the participants. The elevation of LDL-CH levels could be isolated or combined with the HDL-CH decrease and/or the TG increase. Low levels of HDL-CH were observed in 32,3% of the patients, while high TG levels were registered in 55,6% of the participants. The achievement of target LDL-CH levels was predicted by the higher-dose statin therapy (odds ratio 0,44). The analysis based on the ESC/EAS 2011 recommendations has shown that the prevalence of target LDL-CH levels was 12,2% in very high-risk patients (< 1,8 mmol/l), 30,3% in high-risk patients (<2,5 mmol/l), and 53,4% in moderate-risk patients (<3,0 mol/l). Conclusion. Over a half of the statin-treated patients failed to achieve target levels of LDL-CH. The lowest prevalence of target LDL-CH levels was observed in very high-risk and high-risk patients. The predictors of target LDL-CH level achievement included moderate cardiovascular risk and higher-dose statin therapy. The obtained results suggest that the correction of persistent dyslipidemia in statin-treated patients could be achieved via increasing the satin dose and combining lipid-lowering medications

Persistent dyslipidemia in statin-treated patients: Russian real-world clinical practice data (Russian part of the DYSIS Study)

The high prevalence of persistent dyslipidemia in primary and specialised care patients treated with statins justifies the need to identify its reasons and develop the recommendations on the treatment optimization. At present, Russian studies focusing on the achievement of target lipid levels remain scarce, which emphasizes the importance of the problem and its further investigation. Aim. Cross-sectional epidemiological study which assessed the prevalence of persistent dyslipidemia in statin-treated patients and analysed the predictors of the achievement of target lipid levels. Material and methods. The lipid profile parameters were analysed in 1586 statin-treated out-patients with varied levels of cardiovascular risk, taking into account the type of lipid-lowering therapy and its doses. The assessment of the cardiovascular event (CVE) risk and the definition of target levels of low-density lipoprotein cholesterol (LDL-CH), as well as normal levels of triglycerides (TG) and high-density lipoprotein cholesterol (HDL-CH), was based on the clinical recommendations by the European Society of Cardiology (ESC 2007) and by the European Society of Cardiology and the European Atherosclerosis Society (ESC/EAS 2011 ). Results. The analysis based on the ESC 2007 recommendations has demonstrated that the target levels of LDL-CH (<2,5 mmol/l for high-risk patients) were not achieved in 53,5% of the participants. The elevation of LDL-CH levels could be isolated or combined with the HDL-CH decrease and/or the TG increase. Low levels of HDL-CH were observed in 32,3% of the patients, while high TG levels were registered in 55,6% of the participants. The achievement of target LDL-CH levels was predicted by the higher-dose statin therapy (odds ratio 0,44). The analysis based on the ESC/EAS 2011 recommendations has shown that the prevalence of target LDL-CH levels was 12,2% in very high-risk patients (< 1,8 mmol/l), 30,3% in high-risk patients (<2,5 mmol/l), and 53,4% in moderate-risk patients (<3,0 mol/l). Conclusion. Over a half of the statin-treated patients failed to achieve target levels of LDL-CH. The lowest prevalence of target LDL-CH levels was observed in very high-risk and high-risk patients. The predictors of target LDL-CH level achievement included moderate cardiovascular risk and higher-dose statin therapy. The obtained results suggest that the correction of persistent dyslipidemia in statin-treated patients could be achieved via increasing the satin dose and combining lipid-lowering medications

ScreenPro FH - Screening project for familial hypercholesterolemia in central, southern and eastern Europe: Rationale and design

PubMed ID: 28225290Familial hypercholesterolemia (FH) is a genetic disorder with well-known genetic transmission and clinical course. Despite great recent progress, FH is still underestimated, under-diagnosed and thus undertreated. Furthermore it represents a significant healthcare challenge as a common risk factor for the premature development of coronary heart disease. The ScreenPro FH Project is an international network project aiming at improving complex care - from timely screening, through diagnosis to up-to-date treatment of familial hypercholesterolemia in Central, Eastern and Southern Europe. An important task for the project is to harmonise and unify diagnostic and therapeutic approaches in participating countries, where the situation differs from country to country. Countries with more experience should serve as a model for countries developing the FH network

Overview of the current status of familial hypercholesterolaemia care in over 60 countries - The EAS Familial Hypercholesterolaemia Studies Collaboration (FHSC)

Background and aims: Management of familial hypercholesterolaemia (FH) may vary across different settings due to factors related to population characteristics, practice, resources and/or policies. We conducted a survey among the worldwide network of EAS FHSC Lead Investigators to provide an overview of FH status in different countries. Methods: Lead Investigators from countries formally involved in the EAS FHSC by mid-May 2018 were invited to provide a brief report on FH status in their countries, including available information, programmes, initiatives, and management. Results: 63 countries provided reports. Data on FH prevalence are lacking in most countries. Where available, data tend to align with recent estimates, suggesting a higher frequency than that traditionally considered. Low rates of FH detection are reported across all regions. National registries and education programmes to improve FH awareness/knowledge are a recognised priority, but funding is often lacking. In most countries, diagnosis primarily relies on the Dutch Lipid Clinics Network criteria. Although available in many countries, genetic testing is not widely implemented (frequent cost issues). There are only a few national official government programmes for FH. Under-treatment is an issue. FH therapy is not universally reimbursed. PCSK9-inhibitors are available in ∼2/3 countries. Lipoprotein-apheresis is offered in ∼60 countries, although access is limited. Conclusions: FH is a recognised public health concern. Management varies widely across countries, with overall suboptimal identification and under-treatment. Efforts and initiatives to improve FH knowledge and management are underway, including development of national registries, but support, particularly from health authorities, and better funding are greatly needed. © 2018 Elsevier B.V

Overview of the current status of familial hypercholesterolaemia care in over 60 countries - The EAS Familial Hypercholesterolaemia Studies Collaboration (FHSC)

Background and aims: Management of familial hypercholesterolaemia (FH) may vary across different settings due to factors related to population characteristics, practice, resources and/or policies. We conducted a survey among the worldwide network of EAS FHSC Lead Investigators to provide an overview of FH status in different countries. Methods: Lead Investigators from countries formally involved in the EAS FHSC by mid-May 2018 were invited to provide a brief report on FH status in their countries, including available information, programmes, initiatives, and management. Results: 63 countries provided reports. Data on FH prevalence are lacking in most countries. Where available, data tend to align with recent estimates, suggesting a higher frequency than that traditionally considered. Low rates of FH detection are reported across all regions. National registries and education programmes to improve FH awareness/knowledge are a recognised priority, but funding is often lacking. In most countries, diagnosis primarily relies on the Dutch Lipid Clinics Network criteria. Although available in many countries, genetic testing is not widely implemented (frequent cost issues). There are only a few national official government programmes for FH. Under-treatment is an issue. FH therapy is not universally reimbursed. PCSK9-inhibitors are available in ∼2/3 countries. Lipoprotein-apheresis is offered in ∼60% countries, although access is limited. Conclusions: FH is a recognised public health concern. Management varies widely across countries, with overall suboptimal identification and under-treatment. Efforts and initiatives to improve FH knowledge and management are underway, including development of national registries, but support, particularly from health authorities, and better funding are greatly needed. © 2018 Elsevier B.V