ATLANTA – Atorvastatin did prevent early atherosclerosis in children and adolescents with lupus, based on data from 221 patients aged 10-21 years. The results were presented at the annual scientific meeting of the American College of Rheumatology.
"This is a landmark study in the pediatric rheumatology community," said Dr. Laura Schanberg, co-chief of the division of pediatric rheumatology at Duke University Medical Center in Durham, N.C.
To assess the risk of cardiovascular problems, the researchers used an accepted surrogate marker: an ultrasound measurement of the thickening of the carotid arteries. The study participants underwent ultrasound examinations seven times during the 3-year study period.
Overall, the progression of thickening in the arteries was not significantly different between the statin and placebo groups.
"This was a surprise to us," Dr. Schanberg said. The researchers had expected significantly less carotid intima-media thickening (CIMT) in the statin group.
The data were trending toward a positive effect, but the findings did not show enough benefit to recommend routine statin treatment for most children and adolescents with lupus. The difference in CIMT was 0.0024 mm/year in the statin group, vs. 0.0010 mm/year in the placebo group (P =.24).
However, the statin group did achieve statistically significant reductions in high-sensitivity C-reactive protein levels, total cholesterol, and low-density lipoprotein. Changes in lupus disease activity and damage, quality of life measures, and measures of muscle, liver, and neurotoxicity were similar between the two groups.
Previous studies have shown that lupus is a strong risk factor for cardiovascular problems. Pediatric lupus patients are considered at increased risk because they typically live with the disease for a longer period of time. Statins have not previously been studied as a way to reduce cardiovascular risk in children with lupus, but some clinicians already prescribe statins to children with lupus at especially high risk from factors such as high cholesterol, Dr. Schanberg said.
"We wanted to see whether there was a way to decrease the long-term risk" of cardiovascular problems in children with lupus, she said. In this study, the researchers enrolled children and adolescents from 21 sites through the Childhood Arthritis and Rheumatology Research Alliance.
All the children received standard lupus care including aspirin, a multivitamin, hydroxychloroquine, and counseling about a low-cholesterol diet and other cardiovascular risk factors. They were randomized to receive atorvastatin or a placebo.
Of note, the study did not include children at especially high risk for cardiovascular problems, such as those with high cholesterol, said Dr. Schanberg. In fact, a subgroup analysis may reveal certain groups that would benefit from statin use in childhood and adolescence, she said.
Despite the lack of clinical significance, the results showed that atorvastatin was safe and well-tolerated in the study population, and Dr. Schanberg advised clinicians to continue prescribing statins for pediatric lupus patients with abnormal cholesterol or lipid levels.
Dr. Schanberg has served on the advisory board for Bristol-Myers Squibb, and Pfizer provided the drugs used in the study.