Nov. 9, 2010 (Atlanta) -- The routine use of cholesterol-lowering statin drugs in children and adolescents with systemic lupus is not warranted, a new study suggests.
Researchers say the findings surprised them, as children with systemic lupus are at increased risk of early-onset atherosclerosis that progresses rapidly. A buildup of plaque in the artery walls that can lead to heart attacks and strokes, atherosclerosis is typically not diagnosed until adulthood.
"Statins have been shown to help prevent the progression of atherosclerosis and reduce the risk of cardiovascular disease in adults, so we thought children with lupus should be put on statins as soon as they are diagnosed," says Laura Schanberg, MD, professor of pediatrics at Duke University Medical Center in Durham, N.C.
"Our study shows that's not the case. The statins had positive effects on lipid levels and appear to be safe and well tolerated. But their effect on atherosclerosis was not significant enough to warrant routine use," she says.
In systemic lupus, the immune system goes awry, causing widespread inflammation and organ damage. Lupus is an independent risk factor for premature heart disease and stroke, Schanberg says.
She presented the findings here at the annual meeting of the American College of Rheumatology.
No Difference in Artery Changes in Statin, Placebo Groups
All participants also received standard therapy for lupus, which includes aspirin, a daily multivitamin, and hydroxychloroquine. They were also counseled to follow a low-cholesterol diet, exercise regularly, and avoid smoking to reduce their risk of cardiovascular disease.
All underwent ultrasound scans at the start and the end of the study to determine changes in the thickness of the wall of their carotid arteries, the arteries that travel up each side of the neck. "Thickening of the arterial walls has been shown in many studies to be a predictor of increased risk of atherosclerosis and cardiovascular disease," Schanberg tells WebMD.
Results showed that over the course of the study, the thickness of the artery wall increased slightly -- and to a similar extent -- in the Lipitor group and the placebo group.
Total and bad LDL cholesterol levels dropped more in the Lipitor group than in the placebo group. People on Lipitor also achieved lower levels of C-reactive protein, or CRP, a marker of inflammation associated with an increased risk of cardiovascular disease.
There were no differences in overall lupus disease activity between the groups, Schanberg says.
Statins May Be Warranted in Some Kids With Systemic Lupus
Since a child started on a statin would presumably be on the drug for life, and statins can carry long-term side effects and a high price tag, the drawbacks of routine use in children with lupus outweigh the benefits, she says.
"That doesn't mean statins should never be used in kids with lupus," Schanberg says. Statins use may be warranted in children with very high cholesterol and those with kidney disease, both of which are independent risk factors for cardiovascular disease, she says
Timothy Niewold, MD, a lupus expert at the University of Chicago, tells WebMD that further study should offer insights into which children with lupus may benefit from statins.
"Lupus is a very heterogeneous disease. This is the largest study to date on this issue and subgroups analyses should tell us for which children statins are economic and sensible," he says.
While the researchers only looked at Lipitor, there is no reason to believe the findings don't apply to other statins as well, the researchers say.
Schanberg is on the advisory board for Pfizer, which makes Lipitor.
This study was presented at a medical conference. The findings should be considered preliminary as they have not yet undergone the "peer review" process, in which outside experts scrutinize the data prior to publication in a medical journal.