![]() ![]() KIGS (Kabi/Pfizer International Growth Database) was an investigator driven and pharmaceutical company–supported surveillance study ( 8) first established as a survey in Sweden to determine the long-term safety and treatment outcomes of pediatric rhGH therapy (Genotropin Pfizer). ![]() ![]() Various registries/postmarketing surveillance databases were developed to follow rhGH-treated pediatric patients for long-term efficacy and safety in real-world clinical settings, and, in particular, to provide information regarding potential rare serious adverse consequences of rhGH therapy, including recurrent or new malignancies in children with preexisting malignancies, development of intracranial hypertension, unmasking of (type 2) diabetes mellitus, induction of stroke, and a possible association with increased overall mortality ( 3–7). Initially approved only for pediatric GH deficiency (GHD), rhGH treatment currently is approved, depending on the country/region, for 8 indications in children (GHD, Prader-Willi syndrome, children born small for gestational age, Turner syndrome, Noonan syndrome, idiopathic short stature, chronic renal failure, and short stature homeobox-containing gene deficiency ) and 3 in adults (GHD, short bowel syndrome, and HIV wasting syndrome). In 1985, Creutzfeldt-Jakob disease was linked to the use of pituitary-derived hGH leading to its discontinuation, which, shortly thereafter, was followed by the first full regulatory approval worldwide of recombinant hGH (rhGH) by the US Food and Drug Administration and by the European Medicines Agency in the same year ( 2). Children, short stature, growth hormone, KIGS, efficacy, safetyĮffective growth-promoting treatment with pituitary-derived human growth hormone (hGH) was first reported more than 60 years ago ( 1). ![]()
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