Issues and trends in pediatric growth hormone therapy--an update from the GHMonitor observational registry.
The GHMonitor 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 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.
Pitukcheewanont
Pisit
P
Department of Endocrinology, The Keck School of Medicine at USC and Childrens Hospital, Los Angeles, California 90026, USA. dpisit@chla.usc.edu
Desrosiers
Paul
P
Steelman
Joel
J
Rapaport
Robert
R
Fuqua
John S
JS
Kreher
Nerissa C
NC
Hamlett
Anthony
A
D000293:Adolescent; D047072:Aromatase Inhibitors / Q000008:administration & dosage; D015992:Body Mass Index; D005260:Female; D012739:Gonadal Steroid Hormones / Q000627:therapeutic use; D007987:Gonadotropin-Releasing Hormone / Q000819:agonists; D019382:Human Growth Hormone / Q000009:adverse effects / Q000172:deficiency* / Q000627:therapeutic use*; D006801:Humans; D007334:Insulin-Like Growth Factor I / Q000032:analysis; D008297:Male; D009485:Neuroradiography; D009765:Obesity / Q000453:epidemiology; D010349:Patient Compliance; D010372:Pediatrics / Q000639:trends*; D011627:Puberty; D012042:Registries
D047072:Aromatase Inhibitors; D012739:Gonadal Steroid Hormones; D019382:Human Growth Hormone; D007987:Gonadotropin-Releasing Hormone; D007334:Insulin-Like Growth Factor I