High LDL Cholesterol Level, Systemic Lupus Erythematosus
Conditions
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.
Interventions
DRUGRosuvastatin
10 mg per day for 12 weeks
DRUGSimvastatin
20 mg per day
Sponsors
AstraZeneca
Ramathibodi Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage reduction of LDL Cholesterol level | 6 and 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients that have transminitis, myositis or active SLE | 6,12, 18 and 24 weeks |
Countries
Thailand
Contacts
Primary ContactParawee Suwannalai, M.D.
Backup ContactPiyaporn Sirijanchun, M.D.
Outcome results
None listed