Efficacy of Low-dose (10 mg) Rosuvastatin in Korean 4 Statin Benefit Groups Per 2013 ACC/AHA Guideline

Study Overview
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Brief Summary
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This study aimed to evaluate the efficacy of low-dose rosuvastatin (10 mg) in the 4 statin benefit groups requiring high- or moderate-intensity statin therapy according to the 2013 American College of Cardiology/American Heart Association guideline in Korean population.

Detailed Description
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The primary endpoint was percentage reduction in low-density lipoprotein (LDL) cholesterol. Secondary endpoints were percentage reduction in other lipids and achievement of ≥50% reduction in LDL cholesterol. Intention-to-treat analyses were performed.

Official Title
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AssessmeNt of Efficacy of Low-dose rosuvaStatin in KoRean 4 Statin Benefit Groups Per 2013 ACC/AHA Guideline

Conditions
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Dyslipidemias

Intervention / Treatment
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* Drug: Low-dose (10mg) rosuvastatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: subjects with prior history of clinical ASCVD subjects with primary elevation of LDL cholesterol ≥190 mg/dL subjects with diabetes, age 40 to 75 years, and LDL cholesterol 70 to 189 mg/dL subjects without diabetes, age 40 to 75 years, LDL cholesterol 70 to 189 mg/dL, and with estimated 10-year ASCVD risk ≥7.5%. Exclusion Criteria: history of significant statin-induced rhabdomyolysis or myopathy history of a significant hypersensitivity reaction to rosuvastatin uncontrolled diabetes mellitus (HbA1c >9%) uncontrolled hypertension (systolic blood pressure >190 mmHg or diastolic blood pressure >100 mmHg) current active liver disease (alanine aminotransferase and/or aspartate aminotransferase >2 times the upper limit of normal) chronic kidney disease (serum creatinine clearance <30 ml/min) creatine kinase levels >3 times the upper limit of normal use of prohibited concomitant therapies history of malignancy within the last 5 years women who were pregnant, breast-feeding or of childbearing potential without contraception subjects who would take any medication for purposes other than this trial within 30 days after taking this study's medication.

Ages Eligible for Study
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Minimum Age: 21 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 |
| --- | --- |
| Low-dose (10mg) rosuvastatin<br>Four statin benefit groups per 2013 ACC/AHA guideline in Korea | Drug: Low-dose (10mg) rosuvastatin<br>* Low-dose (10mg) rosuvastatin in 4 statin benefit groups per 2013 ACC/AHA guideline<br>* Other names: Crestor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage reduction in low-density lipoprotein (LDL) cholesterol | Percentage reduction in low-density lipoprotein (LDL) cholesterol from baseline to 8 weeks of treatment | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage reduction in other lipids | Percent changes from baseline to 8 weeks in total cholesterol, high-density lipoprotein (HDL) cholesterol, triglyceride (TG), non-HDL cholesterol, apolipoprotein B, apolipoprotein A1 | 8 weeks | 
| Achievement of ≥50% reduction in LDL cholesterol | Achievement of ≥50% reduction in LDL cholesterol with use of rosuvastatin 10 mg in 8 weeks | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cholesterol, LDL, Asian, Rosuvastatin, Low-dose