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Long-term safety and efficacy of the recombinant human growth hormone omnitrope® in the treatment of Spanish growth hormone deficient children: Results of a phase III study
Ist Teil von
Advances in therapy, 2011-10, Vol.28 (10), p.879-893
Ort / Verlag
Heidelberg: Springer Healthcare Communications
Erscheinungsjahr
2011
Link zum Volltext
Quelle
Alma/SFX Local Collection
Beschreibungen/Notizen
Introduction
This phase III study in growth hormone (GH) deficient (GHD) children with growth retardation was designed to demonstrate the safety and efficacy of longterm treatment with the recombinant human GH Omnitrope® (Sandoz BioPharmaceuticals, Holzkirchen, Germany).
Methods
Treatmentnaïve, prepubertal Spanish children (
n
=70) with isolated GHD were treated with Omnitrope 0.03 mg/kg/day subcutaneously. Changes in height, height standard deviation score (HSDS), height velocity (HV), HV standard deviation score (HVSDS), serum insulin-like growth factor (IGF)-1, and insulin-like growth factor binding protein (IGFBP)-3 levels were recorded.
Results
Omnitrope treatment provided a good growth response after 4 years, shown by a significant increase in mean body height (31.1 cm [95% CI: 29.6–32.6]), HSDS (Tanner) (1.42 [1.13–1.70]), HV (2.4 cm [1.7–3.1]), and HVSDS values (3.5 [2.7–4.3]). Mean IGF-1 and IGFBP-3 serum levels also increased significantly.
Conclusion
At a dose of 0.03 mg/kg/day, Omnitrope was safe, effective, and well tolerated during long-term treatment of children with GHD.