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

• Conditions: Dyslipidemias
• Interventions: Drug: Low-dose (10mg) rosuvastatin

• Registration Number: NCT03903029
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-10-10
• Primary Completion: 2015-07-05
• Status Verified: 2019-03
• Study First Submitted: 2019-04-03
• Study First Submitted QC: 2019-04-03
• Last Update Submitted: 2019-04-03
• Study First Posted: 2019-04-04
• Last Update Posted: 2019-04-04
• Study Completion: 2019-12-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 242

Inclusion Criteria

1. subjects with prior history of clinical ASCVD
2. subjects with primary elevation of LDL cholesterol ≥190 mg/dL
3. subjects with diabetes, age 40 to 75 years, and LDL cholesterol 70 to 189 mg/dL
4. 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

1. history of significant statin-induced rhabdomyolysis or myopathy
2. history of a significant hypersensitivity reaction to rosuvastatin
3. uncontrolled diabetes mellitus (HbA1c >9%)
4. uncontrolled hypertension (systolic blood pressure >190 mmHg or diastolic blood pressure >100 mmHg)
5. current active liver disease (alanine aminotransferase and/or aspartate aminotransferase >2 times the upper limit of normal)
6. chronic kidney disease (serum creatinine clearance <30 ml/min)
7. creatine kinase levels >3 times the upper limit of normal
8. use of prohibited concomitant therapies
9. history of malignancy within the last 5 years
10. women who were pregnant, breast-feeding or of childbearing potential without contraception
11. subjects who would take any medication for purposes other than this trial within 30 days after taking this study's medication.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Low-dose (10mg) rosuvastatin	Low-dose (10mg) rosuvastatin	Four statin benefit groups per 2013 ACC/AHA guideline in Korea

Primary Outcome Measures

Name	Time	Method
Percentage reduction in low-density lipoprotein (LDL) cholesterol	8 weeks	Percentage reduction in low-density lipoprotein (LDL) cholesterol from baseline to 8 weeks of treatment

Secondary Outcome Measures

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