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Rohrer, Tilman R.; Ceplis-Kastner, Sabine; Jorch, Norbert; Müller, Hermann L.; Pfaeffle, Roland; Reinehr, Thomas; Richter-Unruh, Annette; Weissenbacher, Claudia; Holterhus, Paul-Martin (2018): Needle-Free and Needle-Based Growth Hormone Therapy in Children: A Pooled Analysis of Three Long-Term Observational Studies. In: Hormone Research in Paediatrics, Vol. 90, No. 6: pp. 393-406
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Background: 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 (R) have been published. Data comparing needle-free administration (NF) and needle injection (NI) of GH are very sparse. Aims: To analyse longitudinal auxological outcome and safety data of GH treatment-naive patients diagnosed with GHD or TS and to compare NF and NI in a real-life setting. Methods: Pooled auxological data and safety information from three consecutive prospective observational Zomacton (R) studies covering 22 years of treatment were analysed and NF was compared to NI. Results: The safety cohort comprised 1,595 patients who received at least one GH dose. The auxological outcome cohort comprised 856 treatment-naive patients with followup 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. Conclusion: Real-life data show that treatment with Zomacton (R) improves auxological outcome parameters without new safety concerns. NF administration of GH represents a useful alternative to NI in children with growth disorders.