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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

242 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-10

Study Completion Date

2019-12-05

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.

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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.

Conditions

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Dyslipidemias

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Low-dose (10mg) rosuvastatin

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

Low-dose (10mg) rosuvastatin

Intervention Type DRUG

Low-dose (10mg) rosuvastatin in 4 statin benefit groups per 2013 ACC/AHA guideline

Interventions

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Low-dose (10mg) rosuvastatin

Low-dose (10mg) rosuvastatin in 4 statin benefit groups per 2013 ACC/AHA guideline

Intervention Type DRUG

Other Intervention Names

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Crestor

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No