Universität zu Köln

Pfaeffle, Roland, Land, Christof, Schoenau, Eckhard, Holterhus, Paul-Martin, Ross, Judith L., de Oliveira, Carolina Piras, Child, Christopher J., Benabbad, Imane, Jia, Nan, Jung, Heike and Blum, Werner F. (2018). Growth Hormone Treatment for Short Stature in the USA, Germany and France: 15 Years of Surveillance in the Genetics and Neuroendocrinology of Short-Stature International Study (GeNeSIS). Horm. Res. Paediatr., 90 (3). S. 169 - 181. BASEL: KARGER. ISSN 1663-2826

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Abstract

Background/Aims: To describe characteristics, auxological outcomes and safety in paediatric patients with growth disorders treated with growth hormone (GH), for cohorts from the USA, Germany and France enrolled in GeNeSIS, a postauthorisation surveillance programme. Methods: Diagnosis and biochemical measurement data were based on reporting from, and GH treatment was initiated at the discretion of, treating physicians. Auxological outcomes during the first 4 years of GH treatment and at near-adult height (NAH) were analysed. Serious and treatment-emergent adverse events were described. Results: Children in the USA (n = 9,810), Germany (n = 2,682) and France (n = 1,667) received GH (dose varied between countries), most commonly for GH deficiency. Across diagnostic groups and countries, mean height velocity standard deviation score (SDS) was > 0 and height SDS increased from baseline during the first 4 years of treatment, with greatest improvements during year 1. Most children achieved NAH within the normal range (height SDS >-2). No new or unexpected safety concerns were noted. Conclusion: GH treatment improved growth indices to a similar extent for patients in all three countries despite variations in GH doses. Data from these three countries, which together contributed > 60% of patients to GeNeSIS, indicated no new safety signals and the benefit-risk profile of GH remains unchanged. (c) 2018 S. Karger AG, Basel

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Pfaeffle, Roland UNSPECIFIED UNSPECIFIED UNSPECIFIED Land, Christof UNSPECIFIED UNSPECIFIED UNSPECIFIED Schoenau, Eckhard UNSPECIFIED UNSPECIFIED UNSPECIFIED Holterhus, Paul-Martin UNSPECIFIED UNSPECIFIED UNSPECIFIED Ross, Judith L. UNSPECIFIED UNSPECIFIED UNSPECIFIED de Oliveira, Carolina Piras UNSPECIFIED UNSPECIFIED UNSPECIFIED Child, Christopher J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Benabbad, Imane UNSPECIFIED UNSPECIFIED UNSPECIFIED Jia, Nan UNSPECIFIED UNSPECIFIED UNSPECIFIED Jung, Heike UNSPECIFIED UNSPECIFIED UNSPECIFIED Blum, Werner F. UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-200487
DOI:	10.1159/000492397
Journal or Publication Title:	Horm. Res. Paediatr.
Volume:	90
Number:	3
Page Range:	S. 169 - 181
Date:	2018
Publisher:	KARGER
Place of Publication:	BASEL
ISSN:	1663-2826
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language IDIOPATHIC SHORT STATURE; TURNER-SYNDROME; PREPUBERTAL CHILDREN; DIABETES-MELLITUS; TREATED CHILDREN; PUBERTAL CHANGES; ADULT HEIGHT; SOCIETY-DRUG; CHILDHOOD; SAFETY Multiple languages Endocrinology & Metabolism; Pediatrics Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/20048