Dr. Ardoin and a Multi-center group of investigators completed an NIH funded Atherosclerosis Prevention in Pediatric Lupus Erythematosus (APPLE) trial. Systemic lupus erythematosus (SLE) significantly increases the risk of developing cardiovascular disease including stroke and heart attack. As available SLE therapies have improved, people with SLE are living longer, and the problem of cardiovascular disease has emerged as a very important long-term concern. Children and adolescents with lupus are at especially high risk as they face a longer burden of disease. Statins are known to prevent atherosclerosis, heart attack and stroke but their effectiveness in SLE, particularly in children and adolescents with SLE, remains unknown. In the APPLE trial, 210 children and adolescents from21 sites in
The APPLE trial did not meet its primary endpoint but did show a trend of less CIMT progression in the atorvastatin-treated participants. Atorvastatin also effectively lowered LDL and c-reactive protein. Atorvastatin was well tolerated without safety concerns. An important observation of the APPLE trial was that the placebo group showed definite progression in CIMT, providing clear evidence that atherosclerosis does begin and progress in children and adolescents with SLE.
Results from the APPLE study do not provide support for routine use of statins in children and adolescents with SLE. Further analysis may identify subgroups that may benefit.
Dr. Stacy Ardoin is currently conducting the following clinical trials: