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| |  DG DISPATCH - WCPGHN: Modest Efficacy For Controlled Ileal-Release Budesonide In Pediatric Crohn's Disease By Maria Bishop Special to DG News
BOSTON, MA -- August 10, 2000 -- Researchers from Toronto's Hospital for Sick Children, in Canada, reported modest efficacy of controlled ileal-release (CIR) budesonide in children with active Crohn's disease. Their study was presented on Wednesday (Aug. 9) at the first World Congress of Pediatric Gastroenterology, Hepatology and Nutrition in Boston, MA. Mary Zachos, MD, of the pediatric gastroenterology department, led the study based on the fact that randomized, controlled trials have shown that CIR budesonide has modest efficacy versus placebo adults with Crohn's disease. The efficacy was shown in acute disease and prolongation of clinical remission, and with fewer adverse effects than with prednisone. Crohn’s disease is usually accompanied by a delay in physical growth and maturation. In this study, therefore, the effects of CIR budesonide therapy on the children's linear growth were of particular interest. Thirty-two adolescents and pre-adolescents with active Crohn's disease of the distal ileum (with or without the right colon) were treated with 9 mg daily of CIR budesonide. At the first follow-up (at a mean of 10.7 weeks), over 51 percent of the participants responded to therapy (29 percent partially and 23 percent completely). Eight of the 10 pre-pubertal responders who continued to receive 6 mg CIR budesonide for more than six months remained free of gastrointestinal symptoms and gained weight. Nevertheless, height velocity was less than four centimeters per year in seven of the 10 participants. Mean height velocity of those 10 children was 3.0 +/- 1.4 cm/year. Dr. Zachos concluded that the data "provide Grade III evidence of modest efficacy of CIR budesonide in children with active Crohn's disease confined to the ileum (with or without the right colon)." "The subnormal growth we observed is concerning, however" she added, "and may reflect either inadequately controlled intestinal inflammation or direct suppression of growth hormone…as is observed with conventional steroids." Randomized, controlled trials of CIR budesonide in pediatric patients are needed, the team felt, and should include parameters of linear growth as outcome variables. Related Link: budesonide.
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