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

Mahidol University

Status and phase

Unknown

Phase 4

Conditions

High LDL Cholesterol Level

Systemic Lupus Erythematosus

Treatments

Drug: Rosuvastatin

Drug: Simvastatin

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00866229

ID03-51-15

Details and patient eligibility

About

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.

Enrollment

140 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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