Effectiveness and Overall Safety of NutropinAq^® for Growth Hormone Deficiency and Other Paediatric Growth Hormone Disorders: Completion of the International Cooperative Growth Study, NutropinAq^® European Registry (iNCGS).

ABSTRACT:

Objective

The International Cooperative Growth Study, NutropinAq^® European Registry (iNCGS) (NCT00455728) monitored long-term safety and effectiveness of recombinant human growth hormone (rhGH; NutropinAq^® [somatropin]) in paediatric growth disorders.

Methods

Open-label, non-interventional, post-marketing surveillance study recruiting children with growth disorders. Endpoints included gain in height standard deviation score (SDS), adult height, and occurrence of adverse events (AEs).

Results

2792 patients were enrolled. 2082 patients (74.6%) had growth hormone deficiency (GHD), which was isolated idiopathic in 1825 patients (87.7%). Non-GHD diagnoses included Turner syndrome (TS) (n=199), chronic renal insufficiency (CRI) (n=10), other non-GHD (n

SUBMITTER: Coutant R 

PROVIDER: S-EPMC8185283 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature