Ohio State Navbar

Our Research

Dr. Stacy Ardoin


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 North America were randomized to receive atorvastatin or placebo for three years in n addition to standard SLE care. Carotid intimal medial thickening (CIMT) was measured to determine whether atorvastatin reduced atherosclerosis development as measured by progression of CIMT.

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.

http://www.ncbi.nlm.nih.gov/pubmed/20861207

http://www.newswise.com/articles/statins-not-routinely-indicated-for-children-and-adolescents-with-lupus

http://www.ncbi.nlm.nih.gov/pubmed/19404953

Dr. Stacy Ardoin and Amanda Kibler are currently conducting the following clinical trials:

  • Laquinimod to Treat Lupus Arthritis, Sponsor: TEVA
  • Assessment of Transition Readiness, Sponsor: Investigator Initiated
  • Lupus Nephritis Histology, Sponsor: Cincinnati Children's Hospital
  • Myocardial Inflammation in SLE, Sponsor: Investigator Initiated
  • Estrogen Effects in Autoimmunity, Sponsor: Investigator Initiated
  • Impact of Fragmentation of Care in Lupus, Sponsor: Investigator Initiated
  • Lupus/Vasculitis Clinic Registry, Sponsor: Investigator Initiated

PubMed list of publications