Bonus coverage of study results announced at ACR/ARHP 2010 showing the effects of statins on cardiovascular disease risk in children with lupus.
Statin therapy did not delay the progression of atherosclerosis, as measured by a surrogate marker of carotid artery wall thickness, in a randomized study of children and adolescents with systemic lupus erythematosus (SLE). However, statin therapy did improve lipid levels and inflammatory markers associated with atherosclerosis compared with placebo. And statin therapy was found to be safe in this group of patients.
“These findings show that statins should not be used routinely for children and adolescents with lupus to reduce the risk of cardiovascular disease. However, we routinely treat children and adolescents who have lupus and have elevated lipid levels or who are nephrotic [ie, losing protein in the urine], and we recommend continuing statins in those groups,” stated lead author Laura E. Schanberg, MD, Duke University Medical School, Durham, NC.
“Atherosclerosis starts at an unusually early age in children with lupus and progresses more quickly in people with lupus. Children with lupus are at increased risk for developing myocardial infarction and stroke, but they are too young to look at endpoints that will show up 20 years later, so we used a surrogate endpoint for atherosclerosis — thickening of the carotid artery wall,” she explained.
Schanberg presented these results of the APPLE trial at a late-breaking abstract session during the 2010 Scientific Sessions of the American College of Rheumatology. “This is the first multicenter pediatric randomized controlled trial studying the use of statins in children with lupus and the longest trial of statins among children, but there is still more work to be done,” she commented at an official Press Conference. “We think there will be specific subgroups of patients in this trial who can benefit from early statin therapy,” she said.
APPLE enrolled 221 SLE patients aged 10 to 21 years and randomized them to atorvastatin or placebo in addition to standard treatment for SLE (hydroxychloroquine, folate, and aspirin) for 36 months. Patients were followed for 36 months and carotid artery thickness was assessed by ultrasound at seven intervals.
There was no statistically significant difference in the progression of carotid intima media thickness between the two treatment groups. Schanberg said that the investigators deemed an increase of .0045 mm of thickening as “clinically meaningful” and neither group progressed to that level. However, atorvastatin significantly reduced levels of C-reactive protein (P=.04), total cholesterol (P<.001), and low density lipoprotein (P<.001). Changes in quality of life, and lupus disease activity scores were similar in both groups of patients.
Importantly, Schanberg said that atorvastatin was safe in this group of children and adolescents. There was no increase in the number and frequency of serious side effects in the atorvastatin-treated group versus placebo. The frequency of pre-defined safety measures of statins — muscle, liver, and neurotoxicity – was similar in both groups.