Issues and trends in pediatric growth hormone therapy - An update from the GHMonitor^SM observational registry

The GHMonitor^SM observational registry collates data on pediatric subjects receiving Saizen® (recombinant human growth hormone (GH)) therapy. From January 2003 through August 2006, 1335 subjects were enrolled in the registry, approximately two-thirds of whom are male. The most common diagnosis in the registry is idiopathic growth hormone deficiency (58%). Most subjects in GHMonitor^SM are receiving Saizen® doses using a needle-free delivery device, the cool.click® (73%). Mean height standard deviation scores show an improvement from -2.1 at screening to -1.1 following 3 years of Saizen® therapy. To date, adverse events have been reported in 4% of subjects. Three serious adverse events were identified to be related to Saizen® by the primary investigator: cellulitis at the injection site, behavioral problems/suicidal ideation, and enlargement of a craniopharyngioma. This article provides an update on data from the registry and briefly discusses topical and controversial issues in the treatment of pediatric patients requiring GH therapy.