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

NCT00866229 | Unknown Phase 4 DMC

• 1 other identifier: ID03-51-15
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Systemic Lupus Erythematosus; High LDL Cholesterol Level

Outcome Measures

Primary Outcomes (1)

• Percentage reduction of LDL Cholesterol level

  6 and 12 weeks

Secondary Outcomes (1)

• Proportion of patients that have transminitis, myositis or active SLE

  6,12, 18 and 24 weeks

Interventions

Rosuvastatin DRUG

10 mg per day for 12 weeks

Simvastatin DRUG

20 mg per day

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ramathibodi Hospital: lead
• AstraZeneca: collaborator

Study Sites (1)

Faculty of Medicine, Ramathibodi Hospital, Mahidol University

Bangkok, 10240, Thailand

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

Rosuvastatin Calcium; Simvastatin

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds

Study Officials

• Parawee Suwannalai, M.D.

  Ramathibodi Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Parawee Suwannalai, M.D.

CONTACT

+31614364578; tepwa@mahidol.ac.th

Piyaporn Sirijanchun, M.D.

CONTACT

+66816810700; tepsrc@mahidol.ac.th

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 19, 2009
• First Posted: March 20, 2009
• Study Start: April 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: June 1, 2010
• Last Updated: March 20, 2009

Record last verified: 2009-03

Locations

TH (1)