%0 Generic
%A R., Pfäffle
%A C., Land
%A E., Schönau
%A P.-M., Holterhus
%A J.L., Ross
%A C., PirasdeOliveira
%A C.J., Child
%A I., Benabbad
%A N., Jia
%A H., Jung
%A W.F., Blum
%D 2018
%T Supplementary Material for: Growth Hormone Treatment for Short Stature in the USA, Germany and France: 15 Years of Surveillance in the Genetics and Neuroendocrinology of Short-Stature International Study (GeNeSIS)
%U https://karger.figshare.com/articles/dataset/Supplementary_Material_for_Growth_Hormone_Treatment_for_Short_Stature_in_the_USA_Germany_and_France_15_Years_of_Surveillance_in_the_Genetics_and_Neuroendocrinology_of_Short-Stature_International_Study_GeNeSIS_/7067354
%R 10.6084/m9.figshare.7067354.v1
%2 https://karger.figshare.com/ndownloader/files/12994745
%2 https://karger.figshare.com/ndownloader/files/12994748
%K Growth hormone treatment
%K Short stature
%K Growth
%K Safety
%K Final height
%X Background/Aims: To describe characteristics, auxological outcomes and safety in paediatric patients with growth disorders treated with growth hormone (GH), for cohorts from the USA, Germany and France enrolled in GeNeSIS, a post-authorisation surveillance programme. Methods: Diagnosis and biochemical measurement data were based on reporting from, and GH treatment was initiated at the discretion of, treating physicians. Auxological outcomes during the first 4 years of GH treatment and at near-adult height (NAH) were analysed. Serious and treatment-emergent adverse events were described. Results: Children in the USA (n = 9,810), Germany (n = 2,682) and France (n = 1,667) received GH (dose varied between countries), most commonly for GH deficiency. Across diagnostic groups and countries, mean height velocity standard deviation score (SDS) was > 0 and height SDS increased from baseline during the first 4 years of treatment, with greatest improvements during year 1. Most children achieved NAH within the normal range (height SDS >−2). No new or unexpected safety concerns were noted. Conclusion: GH treatment improved growth indices to a similar extent for patients in all three countries despite variations in GH doses. Data from these three countries, which together contributed > 60% of patients to GeNeSIS, indicated no new safety signals and the benefit-risk profile of GH remains unchanged.
%I Karger Publishers