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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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Ramathibodi Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
Ramathibodi Hospital
ClinicalTrials.gov Identifier:
NCT00866229
First received: March 19, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  Purpose

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 Intervention Phase
Systemic Lupus Erythematosus
High LDL Cholesterol Level
 Drug: Rosuvastatin
Drug: Simvastatin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ramathibodi Hospital:

Primary Outcome Measures:
  • Percentage reduction of LDL Cholesterol level [ Time Frame: 6 and 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients that have transminitis, myositis or active SLE [ Time Frame: 6,12, 18 and 24 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 140
Study Start Date: April 2008
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Rosuvastatin
    10 mg per day for 12 weeks
    Drug: Simvastatin
    20 mg per day
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00866229

Contacts
Contact: Parawee Suwannalai, M.D. +31614364578 tepwa@mahidol.ac.th
Contact: Piyaporn Sirijanchun, M.D. +66816810700 tepsrc@mahidol.ac.th

Locations
Thailand
Faculty of Medicine, Ramathibodi Hospital, Mahidol University Recruiting
Bangkok, Thailand, 10240
Contact: Pintip Ngamjanyaporn, M.D.     +6622011477     pintiptip@yahoo.com    
Contact: Piyaporn Sirijanchun, M.D.     +6622011477     tepsrc@mahidol.ac.th    
Principal Investigator: Parawee Suwannalai, M.D.            
Sponsors and Collaborators
Ramathibodi Hospital
AstraZeneca
Investigators
Principal Investigator: Parawee Suwannalai, M.D. Ramathibodi Hospital
  More Information

No publications provided

Responsible Party: Parawee Suwannalai , M.D., Ramathibodi Hospital
ClinicalTrials.gov Identifier: NCT00866229     History of Changes
Other Study ID Numbers: ID03-51-15
Study First Received: March 19, 2009
Last Updated: March 19, 2009
Health Authority: Thailand: Ethical Committee

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Simvastatin
Rosuvastatin
Hypolipidemic Agents
Antimetabolites
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 23, 2013