Growth hormone (GH) treatment to final height in children with idiopathic short stature: Evidence for a dose effect - 15/08/11
, Lyset T.M. Rekers-Mombarg, PhD, Gordon B. Cutler, MD, Brenda Crowe, PhD, Tracy J. Beck, PhD, Kristen Roberts, MSc, Anne Gill, MSc, Jean-Louis Chaussain, MD, Herwig Frisch, MD, PhD, Rafael Yturriaga, MD, Andrea F. Attanasio, MDon Behalf of the European Idiopathic Short Stature Study Group
Reprint requests: Jan M. Wit, MD, Department of Pediatrics, Leiden University Medical Center, PO Box 9600, 2300 RC Leiden, the Netherlands.See editorial, p 10.
Abstract |
Objectives |
To investigate in an open-label randomized study, the effect of two doses of growth hormone (GH) on final height and height velocity during the first 2 years of treatment of children with idiopathic short stature (mean baseline height standard deviation score [SDS] −3.2).
Study design |
Patients were treated with GH at 0.24 mg/kg/week, 0.24 mg/kg/week for the first year and at 0.37 mg/kg/week thereafter (0.24→0.37), or 0.37 mg/kg/week. Final height was evaluated in 50 patients at study completion (mean treatment duration, 6.5 years).
Results |
Patients who received 0.37 mg/kg/week (n=72) experienced a significantly greater increase in height velocity than those who received 0.24 mg/kg/week (n=70) (treatment difference=0.8 cm/year; P=.003) or 0.24→0.37 mg/kg/week (n=67) (treatment difference=0.9 cm/year; P=.001). For the 50 patients for whom final height measurements were available, mean height SDS increased by 1.55, 1.52, and 1.85 SDS, respectively, for the three dose groups. For the primary comparison between the 0.37 mg/kg/week and 0.24 mg/kg/week dose groups, the mean treatment difference (adjusted for differences in baseline predicted height SDS) was 0.57 SDS (3.6 cm; P=.025). Mean overall height gains (final height minus baseline predicted height) were 7.2 cm and 5.4 cm for the 0.37 mg/kg/week and 0.24 mg/kg/week dose groups, respectively, without dose effects on safety parameters. Final height measurements were within the normal adult height range for 94% of patients randomized to 0.37 mg/kg/week who continued to final height.
Conclusion |
GH treatment dose-dependently increases height velocity and final height in children with idiopathic short stature.
Le texte complet de cet article est disponible en PDF.Mots-clés : GH, SDS, TW2
Plan
| G. B. Cutler, B. Crowe, T. J. Beck, K. Roberts, and A. Gill are employees and shareholders of Eli Lilly and Company, which sponsored this study. A. Attanasio is a consultant to and shareholder of Eli Lilly and Company. J. M. Wit, J.-L. Chaussain, H. Frisch, and R. Yturriaga were all principal investigators for this study. |
Vol 146 - N° 1
P. 45-53 - janvier 2005 Retour au numéro
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