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

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

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.

Study Overview

• Status: Completed
• Conditions: Dyslipidemias
• Intervention / Treatment: Drug: Low-dose (10mg) rosuvastatin

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 Type: Observational
• Enrollment (Actual): 242

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Four statin benefit groups per 2013 ACC/AHA guideline in Korean

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Low-dose (10mg) rosuvastatin; Four statin benefit groups per 2013 ACC/AHA guideline in Korea	Drug: Low-dose (10mg) rosuvastatin; Low-dose (10mg) rosuvastatin in 4 statin benefit groups per 2013 ACC/AHA guideline; Other Names: Crestor

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Study Chair: Hyo-Soo Kim, MD., PhD., Seoul National University Hospital

Publications and helpful links

General Publications

• Kim KJ, Yoon J, Won KH, Lim SW, Chae IH, Lee SY, Kim SW, Kim HS. Assessment of the Efficacy of Lowering LDL Cholesterol with Rosuvastatin 10 mg in Four Korean Statin Benefit Groups as per ACC/AHA Guidelines (NewStaR4G). J Clin Med. 2020 Mar 27;9(4):916. doi: 10.3390/jcm9040916.

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2014
• Primary Completion (Actual): July 5, 2016
• Study Completion (Actual): December 5, 2019

Study Registration Dates

• First Submitted: April 3, 2019
• First Submitted That Met QC Criteria: April 3, 2019
• First Posted (Actual): April 4, 2019

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Rosuvastatin; Asian; Low-dose; Cholesterol, LDL
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Nutritional and Metabolic Diseases; Dyslipidemias; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Hydrocarbons; Amides; Pyrimidines; Hydrocarbons, Halogenated; Sulfonamides; Sulfones; Fluorobenzenes; Hydrocarbons, Fluorinated; Rosuvastatin Calcium
• Other Study ID Numbers: NewStaR4G

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No