PATRO children, a multi-center, non-interventional study of the safety and effectiveness of Omnitrope
Omnitrope®
growth hormone
growth hormone deficiency
idiopathic short stature
pediatrics
Journal
Journal of pediatric endocrinology & metabolism : JPEM
ISSN: 2191-0251
Titre abrégé: J Pediatr Endocrinol Metab
Pays: Germany
ID NLM: 9508900
Informations de publication
Date de publication:
27 Apr 2021
27 Apr 2021
Historique:
received:
17
06
2020
accepted:
30
11
2020
pubmed:
2
3
2021
medline:
16
11
2021
entrez:
1
3
2021
Statut:
epublish
Résumé
Omnitrope All visits and assessments are carried out according to routine clinical practice, and doses of Omnitrope By September 2018, 294 US patients were recruited; the two largest groups were GHD (n=193) and ISS (n=62). Across all indications, HSDS improvement (ΔHSDS) from baseline at three years was +1.0 (rhGH-naïve, +1.2; pre-treated, +0.7). In pre-pubertal patients, ΔHSDS from baseline at three years was +0.94 (rhGH-naïve, +1.3; pre-treated, +0.7). Following three years of treatment, ΔHSDS from baseline was +1.3 in rhGH-naïve GHD patients and +1.1 in rhGH-naïve ISS patients. In pre-pubertal rhGH-naïve patients, ΔHSDS from baseline was +1.3 and +1.2 in GHD and ISS patients, respectively. Overall, 194 patients (66.0%) experienced adverse events (AEs; n=886 events); most were of mild-moderate intensity. Five patients (1.7%) had AEs that were suspected to be treatment-related (n=5 events). All reported neoplasms were benign, non-serious, and considered unrelated to rhGH therapy. No AEs of diabetes mellitus or hyperglycemia were reported. Omnitrope
Identifiants
pubmed: 33647196
pii: jpem-2020-0360
doi: 10.1515/jpem-2020-0360
doi:
Substances chimiques
Recombinant Proteins
0
Human Growth Hormone
12629-01-5
Types de publication
Journal Article
Multicenter Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
431-440Informations de copyright
© 2020 Philippe Backeljauw et al., published by De Gruyter, Berlin/Boston.
Références
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