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Vol. 76, Suppl. 3, 2011
Issue release date: September 2011
Section title: Paper
Horm Res Paediatr 2011;76(suppl 3):45–47
(DOI:10.1159/000330159)

Safety of Growth Hormone Treatment of Children with Idiopathic Short Stature: The US Experience

Allen D.B.
University of Wisconsin School of Medicine and Public Health and UW American Family Children’s Hospital, Madison, Wisc., USA

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Article / Publication Details

First-Page Preview
Abstract of Paper

Published online: 9/7/2011

Number of Print Pages: 2
Number of Figures: 0
Number of Tables: 0

ISSN: 1663-2818 (Print)
eISSN: 1663-2826 (Online)

For additional information: http://www.karger.com/HRP

Abstract

Recombinant human growth hormone (rhGH) is approved in the United States for treatment of idiopathic short stature (ISS). The occurrence of adverse events (AEs) and the long-term safety of rhGH treatment in this patient population are reviewed. Data were analyzed from postmarketing surveillance studies that included ISS patients, prospective ISS treatment trials and studies of specific AEs in smaller groups of rhGH-treated children. Frequency rates of targeted AEs (i.e., scoliosis, slipped capital femoral epiphysis, intracranial hypertension, pancreatitis) in patients with ISS are similar to or lower than the rates observed in other rhGH-treated conditions. At dosages of 0.24–0.37 mg/kg/week, rhGH treatment in children with ISS does not adversely affect blood glucose levels. At dosages ≧0.3 mg/kg/week, a dose-dependent increase in mean fasting and stimulated insulin levels is observed. Current evidence derived from ‘on-treatment’ surveillance studies suggests that rhGH does not increase the risk for new malignancies in children with ISS.The safety profile of rhGH at doses ≤0.37 mg/kg/week for the treatment of children with ISS is similar to or better than the profile seen in other rhGH-treated conditions and is not associated with any predictable AEs. Due to a continuing trend toward dose escalation to achieve greater height-promoting effects and the possibility of delayed post-treatment effects of hyperinsulinemia and/or heightened GH and insulin-like growth factor I exposure on cancer risk, caution and ongoing scrutiny of risks versus benefits are warranted.


  

Article Information

Published online: September 7, 2011
Number of Print Pages : 3
Number of Figures : 0, Number of Tables : 0, Number of References : 15

  

Publication Details

Hormone Research in Paediatrics (From Developmental Endocrinology to Clinical Research)

Vol. 76, No. Suppl. 3, Year 2011 (Cover Date: September 2011)

Journal Editor: Czernichow P. (Paris)
ISSN: 1663-2818 (Print), eISSN: 1663-2826 (Online)

For additional information: http://www.karger.com/HRP


Article / Publication Details

First-Page Preview
Abstract of Paper

Published online: 9/7/2011

Number of Print Pages: 2
Number of Figures: 0
Number of Tables: 0

ISSN: 1663-2818 (Print)
eISSN: 1663-2826 (Online)

For additional information: http://www.karger.com/HRP


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Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in goverment regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
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