Pediatric endocrinology reviews : PER

An overview of the GHMonitor, a registry of children treated with Saizen somatropin [recombinant hGH for injection].

PMID 16456499


The GHMonitor, introduced in 1998, monitors demographics and outcomes in children treated with Saizen (somatropin [recombinant hGH for injection]). Follow-up data are available on 697 patients. The proportion of male to female patients receiving growth hormone (GH) treatment was 67:33. Severity of the height deficit present at enrollment varied by diagnosis with patients with Turner syndrome being shortest [height standard deviation score (SDS)=-3.7+/-1.7] and those with organic GH deficiency the least severely stunted (height SDS=-1.9+/-1.5). Forty-eight patients (6.9%) discontinued participation in the registry. The most common reason for discontinuing GH was completion of growth; the second was family relocation. There were 53 adverse events reported in 33 patients in 1977 patient-years of followup. Most were self-limited but 13 were serious, and 5 resulted in discontinuation of treatment. Data from The GHMonitor provide a real world glimpse of current North American GH treatment practices.

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S0947000 Somatropin, European Pharmacopoeia (EP) Reference Standard