Systemic Lupus Erythematosus Clinical Trial
The aim of this study is to to determine whether atorvastatin 40mg per day is effective in the treatment of SLE.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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