Browsing by Subject "Human Growth Hormone"

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    GH safety workshop position paper: a critical appraisal of recombinant human GH therapy in children and adults
    (Bioscientifica, 2016-02) Allen, D. B.; Backeljauw, P.; Bidlingmaier, M.; Biller, B. M. K.; Boguszewski, M.; Burman, P.; Butler, G.; Chihara, K.; Christiansen, J.; Cianfarani, S.; Clayton, P.; Clemmons, D.; Cohen, P.; Darendeliler, F.; Deal, C.; Dunger, D.; Erfurth, E. M.; Fuqua, J. S.; Grimberg, A.; Haymond, M.; Higham, C.; Ho, K.; Hoffman, A. R.; Hokken-Koelega, A.; Johannsson, G.; Juul, A.; Kopchick, J.; Lee, P.; Pollak, M.; Radovick, S.; Robison, L.; Rosenfeld, R.; Ross, R. J.; Savendahl, L.; Saenger, P.; Toft Sorensen, H.; Stochholm, K.; Strasburger, C.; Swerdlow, A.; Thorner, M.; Department of Pediatrics, IU School of Medicine
    Recombinant human GH (rhGH) has been in use for 30 years, and over that time its safety and efficacy in children and adults has been subject to considerable scrutiny. In 2001, a statement from the GH Research Society (GRS) concluded that 'for approved indications, GH is safe'; however, the statement highlighted a number of areas for on-going surveillance of long-term safety, including cancer risk, impact on glucose homeostasis, and use of high dose pharmacological rhGH treatment. Over the intervening years, there have been a number of publications addressing the safety of rhGH with regard to mortality, cancer and cardiovascular risk, and the need for long-term surveillance of the increasing number of adults who were treated with rhGH in childhood. Against this backdrop of interest in safety, the European Society of Paediatric Endocrinology (ESPE), the GRS, and the Pediatric Endocrine Society (PES) convened a meeting to reappraise the safety of rhGH. The ouput of the meeting is a concise position statement.
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    Safety Outcomes and Near-Adult Height Gain of Growth Hormone-Treated Children with SHOX Deficiency: Data from an Observational Study and a Clinical Trial
    (S. Karger AG, 2017) Benabbad, Imane; Rosilio, Myriam; Child, Christopher J.; Carel, Jean-Claude; Ross, Judith L.; Deal, Cheri L.; Drop, Stenvert L. S.; Zimmermann, Alan G.; Jia, Nan; Quigley, Charmian A.; Blum, Werner F.; Pediatrics, School of Medicine
    BACKGROUND/AIMS: To assess auxological and safety data for growth hormone (GH)-treated children with SHOX deficiency. METHODS: Data were examined for GH-treated SHOX-deficient children (n = 521) from the observational Genetics and Neuroendocrinology of Short Stature International Study (GeNeSIS). For patients with near-adult height information, GeNeSIS results (n = 90) were compared with a clinical trial (n = 28) of SHOX-deficient patients. Near-adult height was expressed as standard deviation score (SDS) for chronological age, potentially increasing the observed effect of treatment. RESULTS: Most SHOX-deficient patients in GeNeSIS had diagnoses of Leri-Weill syndrome (n = 292) or non-syndromic short stature (n = 228). For GeNeSIS patients with near-adult height data, mean age at GH treatment start was 11.0 years, treatment duration 4.4 years, and height SDS gain 0.83 (95% confidence interval 0.49-1.17). Respective ages, GH treatment durations and height SDS gains for GeNeSIS patients prepubertal at baseline (n = 42) were 9.2 years, 6.0 years and 1.19 (0.76-1.62), and for the clinical trial cohort they were 9.2 years, 6.0 years and 1.25 (0.92-1.58). No new GH-related safety concerns were identified. CONCLUSION: Patients with SHOX deficiency who had started GH treatment before puberty in routine clinical practice had a similar height gain to that of patients in the clinical trial on which approval for the indication was based, with no new safety concerns.