Abstract

The adverse events of growth hormone (GH) treatment in children with Prader-Willi syndrome (PWS) during clinical trials and in the Pharmacia & Upjohn International database (KIGS) have been found to be similar to those observed during GH treatments of children with classic GH deficiency, Turner syndrome, or chronic renal insufficiency. Although there is an increased risk of developing scoliosis in PWS, no significant exacerbation was reported in the clinical trials and only few cases were reported in KIGS. The prevalence of impaired carbohydrate metabolism and diabetes mellitus have been reported to be higher in individuals with PWS, especially obese subjects, than in the normal population. However, clinical studies have found normal or increased insulin sensitivity in children with PWS. During clinical trials with GH treatment, no glucose intolerance or diabetes mellitus was reported. In the KIGS database, only one case of non-insulin-dependent diabetes millitus was reported. Thus, published data suggest that there are few safety risks associated with GH treatment of subjects with PWS, but long-term safety follow-up is required, particularly with regard to effects of GH treatment on glucose metabolism. The Endocrinologist 2000; 10: 63S-64S

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