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
Phase 4
- Conditions
- Systemic Lupus ErythematosusHigh LDL Cholesterol Level
- Registration Number
- NCT00866229
- Lead Sponsor
- Ramathibodi Hospital
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 140
Inclusion Criteria
- SLE patients that on prednisolone more than 30 mg/day
- Normal liver faction: AST and ALT < 80 mg/dl
- Normal muscle enzyme : CPK < 100 U/L
- LDL cholesterol level > 100 mg/dl
Exclusion Criteria
- Patients that was treated with pulse methylprednisolone or corticosteroid equivalent to prednisolone > 1mg/kg/day at screening.
- Statin allergy
- On statin treatment before screening
- On cyclosporine, antifugal (azole group), antibiotics (macrolide group), rifampicin, warfarin, phenytoin
- Pregnancy
- Abnormal liver function: AST or ALT > 80 mg/dl
- Abnormal muscle enzyme : CPK > 300 U/L
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Percentage reduction of LDL Cholesterol level 6 and 12 weeks
- Secondary Outcome Measures
Name Time Method Proportion of patients that have transminitis, myositis or active SLE 6,12, 18 and 24 weeks
Trial Locations
- Locations (1)
Faculty of Medicine, Ramathibodi Hospital, Mahidol University
🇹ðŸ‡Bangkok, Thailand