Efficacy and Adverse Effect of Simvastatin Compare to Rosuvastatin in Systemic Lupus Erythematosus (SLE) Patients With Corticosteroid Therapy and High Low-Density Lipoprotein (LDL) Cholesterol Level
NCT00866229 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 140
Last updated 2009-03-20
Summary
Early statin therapy in SLE patients that have high cholesterol level and other atherosclerosis risk should reduce atherosclerosis and coronary artery events in later course of disease. By the way, statin is used in restricted groups of rheumatologists due to awareness of side effects; myositis and hepatitis, that are frequently found in SLE patients more so than other groups of atherosclerosis patients and reporting data of autoimmune diseases that occur after statin use.
Conditions
- Systemic Lupus Erythematosus
- High LDL Cholesterol Level
Interventions
- DRUG
-
Rosuvastatin
10 mg per day for 12 weeks
- DRUG
-
Simvastatin
20 mg per day
Sponsors & Collaborators
- collaborator INDUSTRY
-
Ramathibodi Hospital
lead OTHER
Principal Investigators
-
Parawee Suwannalai, M.D. · Ramathibodi Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-04-30
- Primary Completion
- 2010-03-31
- Completion
- 2010-06-30
Countries
- Thailand
Study Locations
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