Statins Not Routinely Indicated For Children & Adolescents With Lupus
While statins are known to help prevent the progression of atherosclerosis, research presented this week at the American College of Rheumatology Annual Scientific Meeting in Atlanta indicates they should not be routinely prescribed in children and adolescents with lupus despite their increased risk of premature atherosclerosis.
Lupus, or SLE, is a chronic inflammatory disease that can affect the skin, joints, kidneys, lungs, nervous system, and other organs of the body. Usually, patients have skin rashes and arthritis, as well as fatigue and fever. It is often more severe when it begins in childhood. Lupus has been identified as a strong independent risk factor for heart attack and stroke, and children with lupus are at a particularly high risk because of their lifelong exposure to the disease. Atherosclerosis a buildup of fatty deposits in the artery walls which normally leads to heart attack and strokes in older adults, starts at an at an unusually early age and progresses more quickly in people with lupus.
Statins have been shown to reduce cardiovascular complications and death among the general adult population, but they have not been studied in the prevention of atherosclerosis among young people with lupus. In the largest trial of its kind and the first major trial completed by the Childhood Arthritis and Rheumatology Research Alliance (called CARRA) researchers recently completed a study looking at whether the use of statins would be helpful enough in the prevention of atherosclerosis in children and adolescents with lupus to make it worthwhile for them to start taking at such a young age.
With funding from the National Institute of Arthritis and Musculoskeletal and Skin Diseases of the National Institutes of Health, researchers followed 221 participants (ages 10 to 21) with lupus who were recruited through 21 CARRA sites. The participants were randomly placed into two groups: one received atorvastatin (Lipitor®) and one received placebo for 36 months. Participants also received hydroxychloroquine, aspirin, a daily multi-vitamin, as well as recommendations for a low cholesterol diet and cardiovascular risk factor counseling. All participants continued routine care for lupus as prescribed by their local pediatric rheumatologist.
The researchers used a very accurate ultrasound technique that can detect even tiny differences in the thickening of the arterial wall of the carotid arteries, which has been shown to predict future heart attacks and strokes.
They also studied blood lipid levels, blood markers of inflammation, lupus disease activity and damage as well as each participant's quality of life.
The study showed no clinically important differences in measurements of the carotid artery thickening for those participants taking atorvastatin. However, the study did show that participants on atorvastatin showed improvements in levels of inflammation and lipids in the blood (e.g., lower levels of high-sensitivity C-reactive protein, total cholesterol, and low-density lipoprotein [a combination of protein and fat]). There were no differences in overall lupus disease activity.
"This study shows that while statins decrease CRP and lipid levels in young people with SLE as they do in other populations, statins do not have enough of a positive effect to routinely prescribe them for children with lupus," says Laura E. Schanberg, MD; principal investigator and professor of pediatrics at Duke University Medical Center. "There are risks with all medications, and this data doesn't convince us that the risks are worth it for all children with lupus."
One thing the study did convince researchers of is the safety of statins in people with lupus. In this study, atorvastatin was shown to be safe and well-tolerated among participants with no increase in the number of serious side effects in the atorvastatin group compared to the placebo group. "This shows that statins are safe for most people with lupus," explains Christy Sandborg, MD; co-principal investigator and professor at Stanford University.
This is the first 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. In particular, there are likely subsets of young people with lupus who will benefit from early statin therapy, and the researchers believe this deserves future investigation. "We think the take home message for pediatric rheumatologists is that they shouldn't plan on routinely prescribing statins to their patients just yet," agree Drs. Sandborg and Schanberg.
ACR Meeting November 2010