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- Title
Needle-Free and Needle-Based Growth Hormone Therapy in Children: A Pooled Analysis of Three Long-Term Observational Studies.
- Authors
Rohrer, Tilman R.; Ceplis-Kastner, Sabine; Jorch, Norbert; Müller, Hermann L.; Pfäffle, Roland; Reinehr, Thomas; Richter-Unruh, Annette; Weißenbacher, Claudia; Holterhus, Paul-Martin; Ferring Arzneimittel GmbH, Dr. Sabine Clips-Kastner
- Abstract
>bold<>italic<Background:>/italic<>/bold< Treatment with growth hormone (GH) is standard clinical practice in children with GH deficiency (GHD) or Turner syndrome (TS). Hitherto, no long-term data on auxological outcome and safety of Zomacton® have been published. Data comparing needle-free administration (NF) and needle injection (NI) of GH are very sparse. >bold<>italic<Aims:>/italic<>/bold< To analyse longitudinal auxological outcome and safety data of GH treatment-naïve patients diagnosed with GHD or TS and to compare NF and NI in a real-life setting. >bold<>italic<Methods:>/italic<>/bold< Pooled auxological data and safety information from three consecutive prospective observational Zomacton® studies covering 22 years of treatment were analysed and NF was compared to NI. >bold<>italic<Results:>/italic<>/bold< The safety cohort comprised 1,595 patients who received at least one GH dose. The auxological outcome cohort comprised 856 treatment-naïve patients with follow-up data ≥12 months. Height-SDS and height velocity improved significantly during the first 3 years of treatment. Documented choice of device was available for 658 patients (NF 69.1%, NI 30.9%). NF administration was non-inferior to NI. No previously unknown safety signals occurred. >bold<>italic<Conclusion:>/italic<>/bold< Real-life data show that treatment with Zomacton® improves auxological outcome parameters without new safety concerns. NF administration of GH represents a useful alternative to NI in children with growth disorders.
- Subjects
PITUITARY dwarfism; TURNER'S syndrome; SOMATOTROPIN
- Publication
Hormone Research in Paediatrics, 2018, Vol 90, Issue 6, p393
- ISSN
1663-2818
- Publication type
Article
- DOI
10.1159/000496614