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Abstract
Aim of the study was to evaluate the efficacy and safety of the combined use of statins with ezetimibe in patients of various nosological groups of high and very high cardiovascular risk. Material and methods. A prospective interventional non-randomized study included 40 people, mean age 60.7±9.5 years, high and very high cardiovascular risk, who did not receive statin therapy or took statins without reaching the target low density lipoprotein (LDL) cholesterol values. Patients were recommended to receive high-intensity statin therapy in combination with ezetimibe for 3 months. Biochemical parameters were determined by standard enzymatic methods and the beginning of combined lipid-correcting therapy and after 3 months. Results. In patients with high cardiovascular risk, the level of total cholesterol decreased by 39.7 % 3 months after treatment (6.8 ± 2.5 and 4.7 ± 2.5 mmol/L; p = 0.0001), the level of LDL cholesterol by 52.2 % (4.6 ± 2.4 and 2.8 ± 2.2 mmol/L; p = 0.0001), the TG level by 26 % (2.7 ± 1.1 and 2.0 ± 1.0 mmol/L; p = 0.008). In the group of patients with very high cardiovascular risk, we also noted a decrease in the total cholesterol level by 39.1 % (6.4 ± 1.4 and 4.4 ± 1.2 mmol/L; p = 0.0001), the level of LDL cholesterol by 45.5 % (4.4 ± 1.4 and 2.5 ± 0.9 mmol/L; p = 0.0001). We did not find statistically significant changes in the remaining lipid parameters. LDL cholesterol targets were achieved in 64 % of patients with high and 52 % of very high cardiovascular risk. There were no significant changes in activity of alanine and aspartate amino transferases, content creatine phosphokinase, glucose and glycated hemoglobin, glomerular filtration rate. Conclusions. Initial combination therapy with statin and ezetimibe is well tolerated and can reduce LDL cholesterol levels by 2 times within 3 months in various categories of patients with high and very high cardiovascular risk.
Highlights
Цель исследования – оценить эффективность и безопасность комбинированного применения статинов с эзетимибом у пациентов различных нозологических групп высокого и очень высокого сердечно-сосудистого риска
In patients with high cardiovascular risk, the level of total cholesterol decreased by 39.7 % 3 months after treatment (6.8 ± 2.5 and 4.7 ± 2.5 mmol/L; p = 0.0001), the level of low density lipoprotein (LDL) cholesterol by 52.2 % (4.6 ± 2.4 and 2.8 ± 2.2 mmol/L; p = 0.0001), the TG level by 26 % (2.7 ± 1.1 and 2.0 ± 1.0 mmol/L; p = 0.008)
In the group of patients with very high cardiovascular risk, we noted a decrease in the total cholesterol level by 39.1 % (6.4 ± 1.4 and 4.4 ± 1.2 mmol/L; p = 0.0001), the level of LDL cholesterol by 45.5 % (4.4 ± 1.4 and 2.5 ± 0.9 mmol/L; p = 0.0001)
Summary
Проспективное интервенционное нерандомизированное исследование выполнено в клинике НИИ терапии и профилактической медицины – филиала Института цитологии и генетики СО РАН (НИИТПМ – филиал ИЦиГ СО РАН). Критерии включения: некоторые группы пациентов высокого сердечно-сосудистого риска без поражения органовмишеней, СД ≥ 10 лет или с факторами риска, наличие умеренной хронической болезни почек (ХБП) со скоростью клубочковой фильтрации (СКФ) 30–59 мл/мин/1,73 м2 и очень высокого сердечно-сосудистого риска (документированное атеросклеротическое ССЗ клинически или по результатам обследования, включая перенесенный острый коронарный синдром, стабильную стенокардию, операции реваскуляризации, инсульт/транзиторная ишемическая атака), которые не получают лечение статинами или получают статины без достижения целевых значений ХС ЛПНП [9]. Критерии исключения: пациенты умеренного и низкого сердечно-сосудистого риска, пациенты высокого и очень высокого сердечно-сосудистого риска, у которых достигнут целевой уровень ХС ЛПНП, СКФ менее 30 мл/мин, острый коронарный синдром, острое нарушение мозгового кровообращения или операции реваскуляризации коронарных артерий менее одного года до включения в исследование, выраженные нарушения функции печени, беременность, лактация, алкоголь, наркомания, эндокринопатии (помимо СД 2 типа).
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