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

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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

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

  • history of significant statin-induced rhabdomyolysis or myopathy
  • history of a significant hypersensitivity reaction to rosuvastatin
  • uncontrolled diabetes mellitus (HbA1c >9%)
  • uncontrolled hypertension (systolic blood pressure >190 mmHg or diastolic blood pressure >100 mmHg)
  • current active liver disease (alanine aminotransferase and/or aspartate aminotransferase >2 times the upper limit of normal)
  • chronic kidney disease (serum creatinine clearance <30 ml/min)
  • creatine kinase levels >3 times the upper limit of normal
  • use of prohibited concomitant therapies
  • history of malignancy within the last 5 years
  • women who were pregnant, breast-feeding or of childbearing potential without contraception
  • 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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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