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

• Sponsor: Ramathibodi Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00866229
• Collaborator: AstraZeneca (Industry)
• Enrollment: 140
• Location: 1
• Duration (Months): 26
• Patients Per Site Per Month: 5.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Systemic Lupus Erythematosus; High LDL Cholesterol Level	Drug: Rosuvastatin; Drug: Simvastatin	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 140 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Efficacy and Adverse Effect of Simvastatin Compare to Rosuvastatin in SLE Patients With Corticosteroid Therapy and High LDL Cholesterol Level
• Study Start Date: Apr 1, 2008
• Anticipated Primary Completion Date: Mar 1, 2010
• Anticipated Study Completion Date: Jun 1, 2010

Outcome Measures

Primary Outcome Measures

1. Percentage reduction of LDL Cholesterol level [6 and 12 weeks]

Secondary Outcome Measures

1. Proportion of patients that have transminitis, myositis or active SLE [6,12, 18 and 24 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine, Ramathibodi Hospital, Mahidol University	Bangkok		Thailand	10240

Sponsors and Collaborators

• Ramathibodi Hospital
• AstraZeneca

Investigators

• Principal Investigator: Parawee Suwannalai, M.D., Ramathibodi Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00866229
• Other Study ID Numbers: ID03-51-15
• First Posted: Mar 20, 2009
• Last Update Posted: Mar 20, 2009
• Last Verified: Mar 1, 2009

• Additional relevant MeSH terms: Lupus Erythematosus, Systemic; Rosuvastatin Calcium; Simvastatin

Study Results

No Results Posted as of Mar 20, 2009