2021
DOI: 10.3389/fendo.2021.676083
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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: ObjectiveThe 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.MethodsOpen-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).Results2792 patients were enro… Show more

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Cited by 12 publications
(16 citation statements)
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“…17,24) Side effects of GH therapy have been reported, ranging from a mild injection site reaction, headache, intracranial hypertension, slipped capital femoral epiphysis, to progression of scoliosis. [25][26][27][28] The incidence of these events is rare and varies by diagnostic group.…”
Section: Discussionmentioning
confidence: 99%
“…17,24) Side effects of GH therapy have been reported, ranging from a mild injection site reaction, headache, intracranial hypertension, slipped capital femoral epiphysis, to progression of scoliosis. [25][26][27][28] The incidence of these events is rare and varies by diagnostic group.…”
Section: Discussionmentioning
confidence: 99%
“…Two cases of obesity, three cases of redness and swelling at the injection site, and two cases of a decrease in serum T4 concentration were reported in the GHM group. The side effects of recombinant human GH therapy, currently used as a conventional treatment for ISS, may include injection site hematoma, pain, headache, scoliosis, glucose intolerance, and compromised cardiorespiratory functions [ 34 , 35 ]. In two [ 30 , 31 ] of the three studies [ 29 – 31 ] that reported AE, obesity, decrease in serum T4 concentration, and redness and swelling at the injection site were reported in the GHM group.…”
Section: Discussionmentioning
confidence: 99%
“…A number of pharmaceutical companies have published results from their registries and other longer term results are available [96][97][98][99][100][101][102][103][104]. In general, all groups of patients grew at a more rapid trajectory, especially during the first year.…”
Section: Efficacy Of Biosynthetic Hgh Therapy In Children (Adult Heig...mentioning
confidence: 99%
“…Multiple apparently hGH treatment-related adverse events have been reported but the overall occurrence of serious adverse events has been modest. The significant problems include headache but rarely caused by increased intracranial pressure, and several conditions noted with rapid growth: increased incidence of scoliosis and slipped capital femoral epiphysis, and glucose intolerance, rarely rising to the category of type 2 diabetes mellitus [96][97][98][99][100][101][102][103][104]. Patients at greatest risk for adverse CNS events were those treated with CNS radiation for neoplastic diseases.…”
Section: Safety Of Biosynthetic Hgh Therapy In Children (Short and Lo...mentioning
confidence: 99%