UnknownPhase 4

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

Thailand140 participantsStarted 2008-04

Plain-language 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.

Who can participate

Age range18 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Percentage reduction of LDL Cholesterol level

Timeframe: 6 and 12 weeks

Trial details

NCT IDNCT00866229

SponsorRamathibodi Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-03

Contact for this trial

Parawee Suwannalai, M.D.

+31614364578 tepwa@mahidol.ac.th

View on ClinicalTrials.gov More Systemic Lupus Erythematosus trials