Dyslipidemias
Conditions
Keywords
Cholesterol, LDL, Asian, Rosuvastatin, Low-dose
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.
Interventions
DRUGLow-dose (10mg) rosuvastatin
Low-dose (10mg) rosuvastatin in 4 statin benefit groups per 2013 ACC/AHA guideline
Sponsors
Seoul National University Hospital
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to 79 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Contacts
STUDY_CHAIRHyo-Soo Kim, MD., PhD.
Seoul National University Hospital
Outcome results
None listed