NCT00866229

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

Efficacy and Adverse Effect of Simvastatin Compare to Rosuvastatin in SLE Patients With Corticosteroid Therapy and High LDL Cholesterol Level

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Ramathibodi Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Rosuvastatin	10 mg per day for 12 weeks
DRUG	Simvastatin	20 mg per day

Timeline

• Start date: 2008-04-01
• Primary completion: 2010-03-01
• Completion: 2010-06-01
• First posted: 2009-03-20
• Last updated: 2009-03-20

Locations

1 site across 1 country: Thailand