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

Seoul National University

Status: Unknown

Conditions: Dyslipidemias

Treatments: Drug: Low-dose (10mg) rosuvastatin

Study type: Observational

Funder types: Other

Identifiers

NCT03903029

NewStaR4G

Details and patient eligibility

About

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.

Full 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.

Enrollment: 242 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

242 participants in 1 patient group

Low-dose (10mg) rosuvastatin

Description:

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

Treatment:

Drug: Low-dose (10mg) rosuvastatin