Background Cardiovascular disease is one of the major causes of death in systemic lupus erythematosus (SLE). A study was undertaken to investigate whether treatment with statins would reduce subclinical measures of atherosclerosis over a 2-year period.
Methods 200 patients with SLE without clinical cardiovascular disease were randomised to receive atorvastatin 40 mg daily or an identical placebo. At baseline and after 2 years of follow-up, helical CT scanning (for coronary artery calcium) and carotid duplex (for intima media thickness/plaque) were performed. Patients were seen for measures of disease activity at 1 month, 3 months and quarterly thereafter. The primary outcome variable was change in coronary artery calcium.
Results At baseline, 43% had coronary artery calcium. At 2 years there was no significant difference between the groups in progression of coronary artery calcium, carotid intima media thickness or carotid plaque. There was no significant difference between the groups in disease activity, measures of inflammation or endothelial cell activation.
Conclusion This study provides no evidence that atorvastatin reduces subclinical measures of atherosclerosis or disease activity over 2 years in patients with SLE. In fact, it does not appear to reduce biochemical measures of inflammation. The anti-inflammatory effects of statins observed in the general population were not replicated in this SLE clinical trial.
Clinicaltrials.gov (NCT 00120887).
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Funding The Lupus Atherosclerosis Prevention Study was supported by a grant from the Alliance for Lupus Research, the Arthritis Foundation, the Hopkins Lupus Cohort (NIH AR 43727) and by grant number UL1 RR 025005 from the National Center for Research Resources (NCRR).
Competing interests MAP was formerly on a Pfizer Advisory Board and a Pfizer Speakers Bureau unrelated to atorvastatin. None of the other authors had any other competing interests.
Ethics approval This study was conducted with the approval of the Johns Hopkins University School of Medicine Institutional Review Board. All patients gave informed consent.
Provenance and peer review Not commissioned; externally peer reviewed.