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

Systemic Lupus Erythematosus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00866229
• Other study ID #: ID03-51-15
• Status: Recruiting
• Phase: Phase 4
• First received: March 19, 2009
• Last updated: March 19, 2009
• Start date: April 2008
• Est. completion date: June 2010

Study information

• Verified date: March 2009
• Source: Ramathibodi Hospital
• Contact: Parawee Suwannalai, M.D.
• Phone: +31614364578
• Email: tepwa[@]mahidol.ac.th
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: June 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• High LDL Cholesterol Level
• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Drug:
• Rosuvastatin
10 mg per day for 12 weeks
• Simvastatin
20 mg per day

Locations

Country	Name	City	State
Thailand	Faculty of Medicine, Ramathibodi Hospital, Mahidol University	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
Ramathibodi Hospital	AstraZeneca

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage reduction of LDL Cholesterol level		6 and 12 weeks	No
Secondary	Proportion of patients that have transminitis, myositis or active SLE		6,12, 18 and 24 weeks	Yes