Statin Monotherapy or Statins in Combination With Ezetimibe in Patients for Prevention of CVD

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Lipid Metabolism Disorders, Cardiovascular Diseases

Intervention / Treatment
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* Drug: statin and ezetimibe combination therapy
* Drug: statin monotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| combination therapy group<br>750 Subjects in the statin and ezetimibe combination therapy group | Drug: statin and ezetimibe combination therapy<br>* Receiving statins (atorvastatin/rosuvastatin or others) in combination with ezetimibe 10mg/day in a stable dosing regimen (without changing the dose of the therapy and/or replacing the statin) for 3 or more months at the time of enrolment in the study.<br>* Other names: no other intervention;|
| monotherapy group<br>250 Subjects in the statin monotherapy group | Drug: statin monotherapy<br>* Receiving statins (atorvastatin/rosuvastatin or others) as monotherapy in a stable dosing regimen (without changing the dose of the therapy and/or replacing the statin) for 3 or more months at the time of enrolment in the study.<br>* Other names: no other intervention;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of achieving target LDL (%) | Frequency of achieving target LDL cholesterol levels at the time of enrolment (%) | at the time of enrolment in the study | 
| Average change in LDL (absolute difference) | Average change in LDL cholesterol level from the moment of the index event to inclusion (absolute difference) | 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 (% from the baseline) | Average change in LDL cholesterol level from the moment of the index event to inclusion (% from the baseline) | 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 (% and absolute difference) | Average change in total cholesterol level from the moment of the index event to inclusion (% and absolute difference) | 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 (% and absolute difference) | Average change in LDL cholesterol level from the moment of the index event to inclusion (% and absolute difference) | 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 (% and absolute difference) | Average change in TG level from the moment of the index event to inclusion (% and absolute difference) | 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 | 
| The incidence of liver damage | an increase in ALT/AST levels over 1.5 of the upper limit normal [ULN] | 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 | 
| The frequency of development of muscle damage | an increase in CPK level while excluding other possible factors of the development of the disorder | 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 | 
| Major adverse cardiovascular events (MACE) incidence | 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%. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ezetimibе, Statin, Cardiovascular diseases, Lipid-lowering therapy