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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Statin therapy group (No interventional) | Observational. Statin therapy group: Once daily administered per the locally approved product information of rosuvastatin, simvastatin, atorvastatin, pitavastatin etc,. (except Rosuzet Tab.) |
| |
| Rosuzet tablet group (No interventional) | Observational. Rosuzet Tab.(ezetimibe/rosuvastatin) group: once daily administered per the locally approved product information of Rosuzet Tab. 10/5mg, 10/10mg, 10/20mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational | Other | Statin therapy group and Rosuzet tablet group |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lipid profiles | LDL-C percentage of change in Statin therapy group and Rosuzet group from baseline | 12 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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A Korean dyslipidemia patient who is taking or is scheduled to take statins therapy or Rosuzet tablets
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| Name | Affiliation | Role |
|---|---|---|
| Mi-Jeung KIM | Hanmi Pharmaceutical Company Limited | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hanmi Pharmaceutical Company Limited | Seoul | 05545 | South Korea |
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| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D057832 | Watchful Waiting |
| ID | Term |
|---|---|
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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| 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 |