Retrospective Observational Study of the Efficacy and Safety of Statin Monotherapy or Statins in Combination With Ezetimibe in Patients Receiving Lipid-lowering Therapy in Both Primary and Secondary Prevention of CVD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,000
- 试验地点
- 31
- 主要终点
- Frequency of achieving target LDL (%)
研究概览
简要总结
Retrospective observational study of the efficacy and safety of statin monotherapy or statins in combination with ezetimibe in patients receiving lipid-lowering therapy in both primary and secondary prevention of cardiovascular diseases (CVD). The study will include patients receiving lipid-lowering therapy in both primary and secondary prevention of CVD who have received therapy of interest for ≥ 3 months in the 2 years preceding the signing of informed consent, i.e. statins as monotherapy or in combination with ezetimibe in a stable mode (without dose adjustment and/or statin replacement). Effectiveness of therapy will be evaluated based on the data on changes in baseline levels of total cholesterol (CS), low density lipoproteins (LDL), high density lipoproteins (HDL), triglycerides (TG), data on which will be obtained from primary medical records. Demographic and anthropometric data on patients, information on the history of hyperlipidemia and concomitant diseases will also be obtained. Also, the study will collect data on the development of adverse reactions of particular interest during therapy (liver/muscle damage, major cardiovascular events (MACE).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient can be included in the study only once.
- •Age > 18 years.
- •Patient receiving lipid-lowering therapy with statin monotherapy or statins in combination with ezetimibe for both primary and secondary prevention of CVD.
- •Receiving statins as monotherapy or statins in combination with ezetimibe in a stable dosing regimen for 3 or more months at the time of enrolment in the study.
- •Willingness and ability to sign an informed consent to participate in the study.
- •Availability of primary medical documentation, which allows assessment of all parameters necessary for the study from the moment of initiation of statin monotherapy or statins in combination with ezetimibe.
- •Initiation of lipid-lowering therapy not earlier than 2 years before enrolment into the study.
排除标准
- •Age < 18 years.
- •A diagnosis of familial hypercholesterolemia made prior to study enrolment or the investigator's suspicious of the possible presence of familial hypercholesterolemia.
- •Change in lipid-lowering therapy within 3 months prior to study enrolment.
- •Concomitant administration of omega-3 PUFA with statin monotherapy or combination therapy of statins and ezetimibe, as well as the use of any methods of extracorporeal filtration and/or plasmapheresis.
- •Clinically significant impairment of liver and/or kidney function, which may impede interpretation of test results
- •Presence of hypothyroidism
- •Ezetimibe monotherapy
- •Intolerance to statins at any dose
研究组 & 干预措施
combination therapy group
750 Subjects in the statin and ezetimibe combination therapy group
干预措施: statin and ezetimibe combination therapy (Drug)
monotherapy group
250 Subjects in the statin monotherapy group
干预措施: statin monotherapy (Drug)
结局指标
主要结局
Frequency of achieving target LDL (%)
时间窗: at the time of enrolment in the study
Frequency of achieving target LDL cholesterol levels at the time of enrolment (%)
Average change in LDL (absolute difference)
时间窗: from the moment of initiation of lipid-lowering drug therapy (not earlier than 2 years before enrolment into the study) to inclusion in the study
Average change in LDL cholesterol level from the moment of the index event to inclusion (absolute difference)
Average change in LDL (% from the baseline)
时间窗: from the moment of initiation of lipid-lowering drug therapy (not earlier than 2 years before enrolment into the study) to inclusion in the study
Average change in LDL cholesterol level from the moment of the index event to inclusion (% from the baseline)
Average change in total cholesterol (% and absolute difference)
时间窗: from the moment of initiation of lipid-lowering drug therapy (not earlier than 2 years before enrolment into the study) to inclusion in the study
Average change in total cholesterol level from the moment of the index event to inclusion (% and absolute difference)
Average change in LDL (% and absolute difference)
时间窗: from the moment of initiation of lipid-lowering drug therapy (not earlier than 2 years before enrolment into the study) to inclusion in the study
Average change in LDL cholesterol level from the moment of the index event to inclusion (% and absolute difference)
Average change in TG (% and absolute difference)
时间窗: from the moment of initiation of lipid-lowering drug therapy (not earlier than 2 years before enrolment into the study) to inclusion in the study
Average change in TG level from the moment of the index event to inclusion (% and absolute difference)
The incidence of liver damage
时间窗: from the moment of initiation of lipid-lowering drug therapy (not earlier than 2 years before enrolment into the study) to inclusion in the study
an increase in ALT/AST levels over 1.5 of the upper limit normal \[ULN\]
The frequency of development of muscle damage
时间窗: from the moment of initiation of lipid-lowering drug therapy (not earlier than 2 years before enrolment into the study) to inclusion in the study
an increase in CPK level while excluding other possible factors of the development of the disorder
Major adverse cardiovascular events (MACE) incidence
时间窗: from the moment of initiation of lipid-lowering drug therapy (not earlier than 2 years before enrolment into the study) to inclusion in the study
Within the framework of this study, major adverse cardiovascular events (MACE) are considered as follows: myocardial infarction (MI), unstable angina pectoris, ischaemic stroke, aortocoronary bypass, mammary coronary bypass, coronary artery bypass, peripheral artery surgery, atherosclerotic stenosis of any artery more than 50%.
次要结局
未报告次要终点