Statin Monotherapy and Rosuzet Tab.(Rosuvastatin/Ezetimibe) Administration in Patients With Dyslipidemia in Korea

Study Overview
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Brief Summary
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A Cohort Study for Comparison of Statin Monotherapy and Rosuzet Tab.(Rosuvastatin/Ezetimibe) Administration and Statin Prescription Patterns in Patients With Dyslipidemia in Korea.

Detailed Description
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The main objective of this study is to evaluate the effect of reducing LDL-C levels after 12 months of administration of Statin Monotherapy or Rosuzet Tab.(Rosuvastatin/Ezetimibe) in patients with dyslipidemia in Korea

Official Title
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A Cohort Study for Comparison of Statin Monotherapy and Rosuzet Tab.(Rosuvastatin/Ezetimibe) Administration and Statin Prescription Patterns in Patients With Dyslipidemia in Korea.

Conditions
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Dyslipidemias

Intervention / Treatment
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* Other: Observational


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age≥19 Subject who is taking or is scheduled to take Statins therapy or Rosuzet Tab. Not diagnosed with diabetes Subject who can written informed consent voluntarily Subject can continue to participate for 12 months on Study Exclusion Criteria: Patients for whom use of Rosuzet Tab. and Statin therapy is prohibited (e.g. patient who are hypersensitive to the main or compositional component of this drug, patient with active liver disease, patient with severe renal failure, patient using combinations with cyclosporin) A pregnant or nursing woman

Ages Eligible for Study
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Minimum Age: 19 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 |
| --- | --- |
| Statin therapy group (No interventional)<br>Observational. Statin therapy group: Once daily administered per the locally approved product information of rosuvastatin, simvastatin, atorvastatin, pitavastatin etc,. (except Rosuzet Tab.) | Other: Observational<br>* Statin therapy group and Rosuzet tablet group<br>|
| Rosuzet tablet group (No interventional)<br>Observational. Rosuzet Tab.(ezetimibe/rosuvastatin) group: once daily administered per the locally approved product information of Rosuzet Tab. 10/5mg, 10/10mg, 10/20mg | Other: Observational<br>* Statin therapy group and Rosuzet tablet group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipid profiles | LDL-C percentage of change in Statin therapy group and Rosuzet group from baseline | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipid profiles | LDL-C percentage of change in Statin therapy group and Rosuzet group from baseline | 6 months | 
| Lipid profiles | Triglyceride, HDL-C, Total Cholesterol percentage of change in Statin therapy group and Rosuzet group from baseline | 6, 12 months | 
| Occurrence and aspect of new onset diabetes and adverse events | Occurrence and aspect of new onset diabetes and adverse events in Statin therapy group and Rosuzet group during the study period | 12 months | 
| Prescription rate | Prescription rate of Statin therapy group and Rosuzet group during the study period | 12 months | 
| Reason for medication change | Evaluation of Rate on reason for medication change in Statin therapy group and Rosuzet group during the study period | 12 months | 
| Medication compliance | MPR(medication possession ratio) of Statin therapy group and Rosuzet group during the study period | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Statin, Rosuvastatin, New onset DM, LDL-C