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APPLE: Atorvastatin fails to slow progression of atherosclerosis in pediatric patients with lupus

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During a 3-year period, researchers found no significant effect on subclinical atherosclerosis progression with routine statin use in young patients with systemic lupus erythematosus.

Participants in the Atherosclerosis Prevention in Pediatric Lupus Erythematosus (APPLE) trial were randomly assigned to receive a daily dose of 10 mg or 20 mg atorvastatin (Lipitor, Pfizer; n=113) or placebo (n=108) in addition to usual care. The dosage was assigned depending on the weight of the participant. The study was conducted between August 2003 and November 2006.

Researchers found no significant difference in the primary endpoint of carotid intima-medial thickening progression between patients assigned atorvastatin (0.0010 mm/year) vs. placebo (0.0024 mm/year; P=.24). Carotid intima-medial thickness progressed significantly in the placebo group (0.0023 mm/year to 0.0144 mm/year; P<.05) across all outcomes. High-sensitivity C-reactive protein (P=.04), total cholesterol (P<.001) and LDL (P<.001) were lower in the atorvastatin group vs. placebo.

Researchers found no difference in serious adverse events and critical safety measures between the groups.

In an accompanying editorial, Angelo Ravelli, MD, associate professor of pediatrics at the University of Genoa, wrote, “Patients with systemic lupus erythematosus are five to eight times more likely to develop premaster CHD compared with the general population. Furthermore, over the past 3 decades mortality in patients with systemic lupus erythematosus has decreased for all causes except CVD. Atherosclerosis is known to begin in childhood, even in healthy populations. Hence, patients who are diagnosed with systemic lupus erythematosus during childhood or adolescence are particularly susceptible to a long-term threat to their CV health, owing to their life-long burden of exposure to a multisystem inflammatory disease with a high atherogenic potential.”

Disclosure: Among the study researchers, Dr. Evans has served as a consultant for ImagePace and AstraZeneca and has been an expert panel member for Merck/Schering Plough; Dr. McCurdy holds stock on Amgen; and Dr. Schanberg has served as a consultant for Pfizer. All other researchers and editorialist Dr. Ravelli report no relevant financial disclosures.

For more information:

• Schanberg LE. Arthritis Rheum. 2011;doi:10.1002/art.30645.
• Ravelli A. Arthritis Rheum. 2011;doi:10.1002/art.30642.

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