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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2010-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Systemic Lupus Erythematosus High LDL Cholesterol Level

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Rosuvastatin

10 mg per day for 12 weeks

Intervention Type DRUG

Simvastatin

20 mg per day

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No