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- Title
A 4-Year, Open-Label, Multicenter, Randomized Trial of Genotropin® Growth Hormone in Patients with Idiopathic Short Stature: Analysis of 4-Year Data Comparing Efficacy, Efficiency, and Safety between an Individualized, Target-Driven Regimen and Standard Dosing
- Authors
Counts, Debra R.; Silverman, Lawrence a.; Rajicic, Natasa; Geffner, Mitchell E.; Newfield, Ron S.; Thornton, Paul; Carakushansky, Mauri; Escobar, Oscar; Rapaport, Robert; Levitsky, Lynne; Rotenstein, Deborah; Hey-Hadavi, Judith; Wajnrajch, Michael P.
- Abstract
Background/Aims: Growth hormone (GH) treatment regimens for children with non-GH-deficient, idiopathic short stature (ISS) have not been optimized. To compare the efficacy, efficiency, and safety of an individualized, target-driven GH regimen with standard weight-based dosing after 4 years of treatment. Methods: This is a 4-year, open-label, multicenter, randomized trial comparing individualized, formula-based dosing of Genotropin® versus a widely used ISS dose of Genotropin®. Subjects were prepubertal, had a bone age of 3-10 years for males and 3-9 years for females, were naive to GH treatment, and had a height standard deviation score (Ht SDS) of -3 to -2.25, a height velocity <25th percentile for their bone age, and peak stimulated GH >10 ng/ml. After the first 2 years, the individualized-dosing group was further randomized to either 0.18 or 0.24 mg/kg/week. Results: At 4 years, subjects in all treatment regimens achieved similar average height gains of +1.3 SDS; however, the individualized dosing regimen utilized less GH to achieve an equivalent height gain. Conclusion: Individualized, formula-based GH dosing, followed by a dose reduction after 2 years, provides a more cost-effective growth improvement in patients with ISS than currently employed weight-based regimens. © 2015 S. Karger AG, Basel
- Subjects
HORMONE deficiencies; SHORT stature; SOMATOTROPIN; HORMONE therapy; STANDARD deviations; THERAPEUTICS
- Publication
Hormone Research in Paediatrics, 2015, Vol 84, Issue 2, p79
- ISSN
1663-2818
- Publication type
Article
- DOI
10.1159/000381642