An Open Labeled Pilot Study of Atorvastatin in Systemic Lupus Erythematosus

Systemic Lupus Erythematosus Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00432354
• Other study ID #: DTCRD 96-03
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: February 6, 2007
• Last updated: March 19, 2007
• Start date: March 2007
• Est. completion date: March 2009

Study information

• Verified date: March 2007
• Source: Buddhist Tzu Chi General Hospital
• Contact: Ming-Chi Lu, MD
• Phone: 886-5-2648000
• Email: e360187[@]yahoo.com.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to to determine whether atorvastatin 40mg per day is effective in the treatment of SLE.

Description:

Background: Statins are lipid-lower agents with pleiotropic effects. Beyond the traditional effect as inhibitors of 3-hydroxy-3methylglytaryl coenzyme A (HMG-CoA) reductase, it has anti-inflammatory and immunomodulatory properties. The administration of atorvastatin to lupus-prone model NZB/W F1 mice results in a significant reduction in serum IgG anti-dsDNA Abs and decreased proteinuria. In a pilot study with three patients with SLE, simvastatin induced rapid and significant reduction in proteinuria levels. However, further randomized double-blinded placebo-controlled study is pending.

Objective: The goal of this study was to evaluate the clinical efficacy and laboratory effect of atorvastatin in SLE.

Methods: Forty patients with SLE will randomize in two groups to receive atorvastatin or not as an adjuvant to immunosuppressive agent therapy. Patients who received atorvastatin for 6 months will stop atorvastatin for 8 weeks as a washout period. We will cross over the placebo and experimental groups, then given atorvastatin for another 6 months. Primary outcome is improvement of lupus disease status measured by SLEDAI and microcirculation improvement via nailfold capillaroscopy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 80 Years

Eligibility

Inclusion Criteria:

1. 16–80 years of age, fulfilling ACR criteria for the classification of SLE (no limit on disease duration)

2. Active disease status including (1) active nephritis with moderate proteinuria (between 1.0gm/day and 2.5gm/day) despite ongoing immunosuppressive therapy or (2) moderate active extra-renal component of the SLEDAI score in the range of 3 to 10. The SLE-DAI score should have been stable for at least two weeks prior to screening.

3. The type and number immunosuppressive agents were not changed in recent one months

Exclusion Criteria:

1. inability to give informed consent;

2. myositis (CK>3×normal value);

3. dialysis or serum creatinin>2.5mg/dL;

4. abnormal liver function (ALT>3×normal value);

5. pregnant or breastfeeding;

6. life-threatening illness that would interfere with ability to complete the study;

7. current drug or alcohol abuse

8. Already under statin therapy

9. Active SLE disease need added new immunosuppressive agent or increased current drug dosage for more than 50%.

Study Design

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

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Drug:
• atorvastatin

Locations

Country	Name	City	State
Taiwan	Buddhist Dalin Tzu Chi General Hospital	Chia-Yi
Taiwan	Dalin Tzu Chi General Hospital	Chia-yi

Sponsors (2)

Lead Sponsor	Collaborator
Buddhist Tzu Chi General Hospital	Pfizer

Country where clinical trial is conducted

Taiwan, 

References & Publications (2)

Kiss E, Soltesz P, Der H, Kocsis Z, Tarr T, Bhattoa H, Shoenfeld Y, Szegedi G. Reduced flow-mediated vasodilation as a marker for cardiovascular complications in lupus patients. J Autoimmun. 2006 Dec;27(4):211-7. Epub 2006 Nov 7. Review. — View Citation

McCarey DW, McInnes IB, Madhok R, Hampson R, Scherbakov O, Ford I, Capell HA, Sattar N. Trial of Atorvastatin in Rheumatoid Arthritis (TARA): double-blind, randomised placebo-controlled trial. Lancet. 2004 Jun 19;363(9426):2015-21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome was the change in SLE-DAI, a validated composite disease activity score.
Secondary	The secondary endpoint was the improvement of microcirculation evaluated by Raynaud’s condition score and nailfold capillaroscopy in the beginning and end of the atorvastatin.