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)

Coutant, Régis; Muñoz, Jordi Bosch; Dumitrescu, C; Schnabel, Dirk; Sert, Caroline; Perrot, Valérie; Dattani, Mehul

doi:10.3389/fendo.2021.676083

Cited by 9 publications

(16 citation statements)

References 25 publications

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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%

The association between idiopathic scoliosis and growth hormone treatment in short children

Park

Kim

et al. 2022

Ann Pediatr Endocrinol Metab

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Purpose: Idiopathic scoliosis is the most common form of scoliosis, and the risk of onset and progression has been found to correlate with growth spurts. Therefore, treatment with recombinant human growth hormone (GH) treatment in short children may initiate and/or aggravate scoliosis. The aim of this study was to investigate the relationship between idiopathic scoliosis and GH treatment in short children.Methods: The medical records of 113 subjects seen at the participating institution between January 2010 and December 2020 and who were diagnosed with GH deficiency and small for gestational age, had idiopathic short stature, and were treated with GH for at least one year were reviewed. Scoliosis was defined as a Cobb angle greater than 10 degrees as assessed using a spine x-ray. Clinical data and laboratory findings before and 12 months after GH treatment were compared.Results: There was significant increase in height, height-standard deviation score, insulin-like growth factor 1, and insulin-like growth factor binding protein 3 (p<0.001) with GH treatment. However, there were no significant differences in the average Cobb angle (6.2°±3.3° vs. 6.1°±3.5°, p=0.842) and the prevalence of scoliosis (9.7% vs. 13.3%, p=0.481) before and after one year of GH treatment. A comparative analysis of both initial Cobb angle and change in Cobb angle during GH treatment showed no relationship with other factors.Conclusion: Although GH treatment in short children increased height and growth velocity, it was not associated with development or aggravation of idiopathic scoliosis.

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Section: Discussionmentioning

confidence: 99%

The association between idiopathic scoliosis and growth hormone treatment in short children

Park

Kim

et al. 2022

Ann Pediatr Endocrinol Metab

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“…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%

Effectiveness and Safety of Combination Therapy with Herbal Medicine and Growth Hormone Compared to Growth Hormone Monotherapy for Short Stature Children: A Systematic Review and Meta-Analysis

Shim

Ahn

Lee

et al. 2022

Evidence-Based Complementary and Alternative Medicine

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Introduction. Herbal medicines (HM) and growth hormones (GH) are widely used to treat short stature (SS) in children. This systematic review aimed to evaluate the effectiveness and safety of combination therapy with HM and GH (CHG) compared to those of GH monotherapy (GHM) in children with SS. Methods. We searched 17 electronic databases from inception to 1 April 2021. Only randomized controlled trials (RCTs) were included. Two authors independently performed the selection and quality assessment of the included studies using Cochrane Handbook criteria. Relative risk (RR) was used to measure dichotomous outcomes with a 95% confidence interval (CI). Mean difference (MD) or standard MD (SMD) was used to measure continuous outcomes with a 95% CI. Results. Seven RCTs involving 455 participants with SS were included. Standard deviations in height (MD = 0.31, 95% CI: 0.24–0.38, p < 0.00001 ), and insulin-like growth factor binding protein-3 (MD = 1.39, 95% CI: 0.93–1.85, p < 0.00001 ) were significantly higher in the CHG group than in the GHM group. Growth velocity (MD = 1.82, 95% CI: 1.34–2.31, p < 0.00001 ) and insulin-like growth factor-1 (MD = 61.85, 95% CI: 55.80–67.90, p < 0.00001 ) were significantly higher in the CHG group. Adverse events were significantly lower in the CHG group (risk ratio: 0.10, 95% CI: 0.02–0.54, p = 0.007 ). However, the level of evidence was low. Conclusions. CHG demonstrated significantly better efficacy than GHM for treating SS, with a low incidence of adverse events. However, since the level of evidence is low, methodologically standardized RCTs are required to verify these results.

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“…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%

Growth and Growth Hormone through the Ages: Art and Science

Rogol

Reiter

2022

Horm Res Paediatr

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Background: People have long been fascinated with the size and growth of living things, from the giants of classic mythology and art to the little people who also have appeared in classical art, as well as the courts of European monarchs, and were exploited in “shows.” Serious medical evaluation began in the late 19th century with the description of acromegaly and its association with pituitary tumors. In the early 20th century, multiple investigators attempted to extract a growth-promoting factor from the anterior pituitary and then, over the decades, to purify it and distinguish it from other anterior pituitary hormones. With relatively pure growth hormone (GH), its biological activity in growth promotion and as a metabolic hormone were studied, and species specificity became apparent: primate GH was the only GH active in man. Human GH was prepared from cadaveric pituitaries and distributed by the NIH to treat children with GH deficiency, but there was never enough pituitary hGH for all of the children who required it. When Creutzfeldt-Jakob disease was found in some patients who received pituitary GH, the production and FDA approval of biosynthetic hGH dramatically accelerated. With a large supply, one could treat those who were GH deficient and test its efficacy in other causes of short stature; longer acting versions of hGH have now been developed, tested, and in a few instances received FDA approval. Summary: It has been a long journey from the description of over- and underproduction of GH in animals to the production and clinical use of the biosynthetic hormones. Key Messages: The efforts of basic scientists led to the extraction and purification of GH. Clinical scientists have expanded the appropriate use of hGH for short children with conditions in addition to GH deficiency.

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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)

Cited by 9 publications

References 25 publications

The association between idiopathic scoliosis and growth hormone treatment in short children

The association between idiopathic scoliosis and growth hormone treatment in short children

Effectiveness and Safety of Combination Therapy with Herbal Medicine and Growth Hormone Compared to Growth Hormone Monotherapy for Short Stature Children: A Systematic Review and Meta-Analysis

Growth and Growth Hormone through the Ages: Art and Science

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