Monitoring rhGH Safety: rhGH Registries, SAGhE and Future Needs.
Pediatr Endocrinol Rev
; 16(Suppl 1): 150-161, 2018 Sep.
Article
em En
| MEDLINE
| ID: mdl-30378793
ABSTRACT
The safety of growth hormone (GH) therapy in children has been studied extensively. The identification of Creutzfeldt-Jacob disease in individuals who received pituitary-derived GH led to heightened surveillance for safety issues related to recombinant human GH (rhGH). An excellent safety profile of rhGH has been demonstrated in large Phase IV registries comprising > 600,000 patient-years of rhGH exposure and long-term safety cohorts of adults treated with GH as children. Increased mortality risk has been reported but eliminated when corrected for small size at birth. Increased risk of mortality from cerebrovascular disease has been reported but interpretation of these events remains difficult due to the lack of appropriate control groups and a lack of replication of these findings in other studies. The advent of new long-acting growth hormone (LAGH) products provides an opportunity for the development of cohorts of individuals receiving LAGH replacement therapy for continued long-term safety studies.
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Texto completo:
1
Bases de dados:
MEDLINE
Assunto principal:
Sistema de Registros
Tipo de estudo:
Prognostic_studies
Limite:
Humans
Idioma:
En
Revista:
Pediatr Endocrinol Rev
Assunto da revista:
ENDOCRINOLOGIA
/
PEDIATRIA
Ano de publicação:
2018
Tipo de documento:
Article