The growth and cardiovascular effects of high dose growth hormone therapy in idiopathic short stature

Barton, John; Gardiner, Helena M.; Cullen, Shay; Hindmarsh, Peter C.; Brook, C. G. D.; Preece, MA

doi:10.1111/j.1365-2265.1995.tb02689.x

Cited by 33 publications

(39 citation statements)

References 34 publications

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“…GVSDS showed a significant increase in GHtreated children at 1 year in prepubertal children (p < 0.001) 40 and pubertal children (p < 0.05) 41 compared with untreated controls, and at 6 months in prepubertal children compared with those receiving placebo (p < 0.0001).…”

Section: Gvsdsmentioning

confidence: 92%

“…In the Soliman trial, 23 a change in HtSDS was also shown after 1 year of GH treatment in prepubertal children, from -2.55 ± 0.5 to -1.7 ± 0.45 in the GH-treated group, compared with a change from -2.8 ± 0.96 to -2.6 ± 0.9 in untreated controls (p < 0.05). The Barton trial 40 testing prepubertal children found no significant differences in HtSDS between treated and untreated children after 1 year, even when considering a high dose of GH (40 IU/m 2 per week). In the Volta trial, 41 a significant change in HtSDS from baseline was reported after 1 year of GH treatment in pubertal children in whom HtSDS changed from -2.2 ± 0.2 to -1.7 ± 0.2 (p < 0.05), compared with no change in untreated controls or those children receiving LHRHa.…”

Section: Htsdsmentioning

confidence: 96%

“…Inclusion criteria for participants were broadly similar, specifying short normal children less than the 3rd percentile in height, with no chronic illness or dysmorphic syndromes. Five studies 23,[38][39][40]43 included children who were prepubertal, and two studies 37,41 had pubertal children, one of which included girls only. 37 Six of the trials 23,37-41 compared GH-treated children with untreated controls, with an additional treatment group receiving luteinising hormone-releasing hormone analogue (LHRHa) to delay puberty in one trial, 41 and an additional group of patients who did not give consent to randomisation in another trial.…”

Section: Rctsmentioning

confidence: 99%

“…Only one of the trials 43 received a score of 3/5, but it did not describe the randomisation method used or give details of withdrawals. All of the five trials 23,37,39,40,42 receiving scores of 2/5 did not describe the method of randomisation used, four trials lacked any mention of blinding, 23,37,39,40 and one trial 42 did not give details of blinding or withdrawals. The trials receiving scores of 1/5 did not give adequate description of randomisation, did not mention blinding, and did not clearly describe drop-outs and withdrawals.…”

Section: Rctsmentioning

confidence: 99%

See 3 more Smart Citations

Clinical effectiveness and cost-effectiveness of growth hormone in children: a systematic review and economic evaluation

Bryant

Cave

Mihaylova

et al. 2002

Health Technol Assess

139

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Section: Gvsdsmentioning

confidence: 92%

Section: Htsdsmentioning

confidence: 96%

Section: Rctsmentioning

confidence: 99%

Section: Rctsmentioning

confidence: 99%

See 2 more Smart Citations

Clinical effectiveness and cost-effectiveness of growth hormone in children: a systematic review and economic evaluation

Bryant

Cave

Mihaylova

et al. 2002

Health Technol Assess

139

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“…Several randomized trials have demonstrated that GH administration accelerates growth in the short term (6)(7)(8). Furthermore, most, but not all, nonrandomized long-term studies suggest that GH increases adult height of children with idiopathic short stature (9)(10)(11)(12)(13)(14)(15)(16)(17)(18).…”

Section: Efficacy Of Gh Treatment In Issmentioning

confidence: 99%

Management of children with idiopathic short stature

Dunkel

2006

eur j endocrinol

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The Food and Drug Administration (FDA) approved the use of biosynthetic GH for the treatment of children with idiopathic short stature (ISS) in the US in 2003. Primarily, the decision was based on two studies: a randomized placebo-controlled study and a dose-response study, both demonstrating an increase in adult height over the predicted height at baseline and over placebo-treated controls by an average of 4-7 cm. Despite these data and FDA approval of GH treatment for ISS, there is still a significant controversy among paediatric endocrinologists about how, and to what extent, GH should be used in this indication. GH is clearly efficacious in several growth disorders and has the potential to alleviate debilitating short stature. However, it has been questioned whether ISS should be considered a condition warranting pharmacological treatment, whether the degree of morbidity of untreated ISS is clinically significant, and whether improved psychosocial status or well-being is achieved through GH treatment and height gain. The benefits must outweigh treatment costs and risks to justify GH treatment in ISS. The safety of GH treatment in ISS has been the main subject in two recent articles from pharmaceutical companies that conducted the pioneering studies mentioned earlier. No new safety concerns were observed in the ISS populations, but there were some limitations in study designs that prevent clinicians, their patients and families from 'resting assured'. Studies addressing these controversial issues are needed before the widespread use of GH treatment in ISS is warranted. European Journal of Endocrinology 155 S35-S38

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Recombinant growth hormone for idiopathic short stature in children and adolescents

Bryant¹,

Cave²,

Milne³

2003

Cochrane Database of Systematic Reviews

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Results suggest that growth hormone therapy can increase short-term growth and improve (near) final height. Increases in height are such that treated individuals remain relatively short when compared with peers of normal stature. Further research in the form of large, multicentre RCTs are required. These should focus on final height, which is the best outcome for assessing the effects of growth hormone, and address quality of life and cost issues.

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The growth and cardiovascular effects of high dose growth hormone therapy in idiopathic short stature

Cited by 33 publications

References 34 publications

Clinical effectiveness and cost-effectiveness of growth hormone in children: a systematic review and economic evaluation

Clinical effectiveness and cost-effectiveness of growth hormone in children: a systematic review and economic evaluation

Management of children with idiopathic short stature

Recombinant growth hormone for idiopathic short stature in children and adolescents

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