Safety and efficacy of growth hormone treatment: GeNeSIS study in Spain

Tomás, C. Luzuriaga; Irigoyen, Miren Oyarzábal; Cepas, E. Caveda; García-Pérez, L.E.

doi:10.1016/j.anpede.2015.05.025

Cited by 4 publications

(2 citation statements)

References 30 publications

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“…Patients should be diagnosed before the age of 5 years, because the treatment results are closely related to the age when the treatment is initiated. The studies recommend to start the treatment at an early age in the prepubertal stage, the most relevant results being noticed in children younger than 4 years [6,24]. It is most reasonable to initiate postnatal growth hormone treatment when growth deficiency begins to be visible independently of the age.…”

Section: Discussionmentioning

confidence: 99%

New Insights in Growth Hormone Stimulation Tests Protocols

Armean

Pop

Gherlan

et al. 2018

Acta Medica Marisiensis

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Objective: The objective of this study was to analyze the performance of 2 stimulation tests used in the diagnosis of growth hormone deficiency.Method: A retrospective study was conducted on a non-random sample of 310 patients, between 2 and 20 years old, who were hospitalized in the Mureș County Hospital’s Endocrinology Department and in the National Institute of Endocrinology C.I. Parhon with short stature between 2009-2015. Inclusion criteria: all subjects who underwent growth hormone stimulation tests in accordance with the national protocol. Microsoft Office Excel was used for data collection and MedCalc v 12.5 was used for statistical analysis.Results: From the total of 310 patients, 102 were diagnosed in Târgu Mureș and 208 in Bucharest. Sex ratio favored boys (boys:girls 1.64:1). In 173 subjects growth hormone deficiency was confirmed. For both tests the percentage of maximum response was the highest for the 60 minutes blood sample regardless if the test were positive or not. Both tests have 100% sensitivity and negative predictive value, with the highest specificity for the 60 minutes clonidine and 30 minutes insulin. The false positive rate was 60% for the insulin test and 27.2% for clonidine for Târgu Mureș sample and 86.9% for the insulin test and 62.5% for clonidine for Bucharest sample. The concordance of the 2 tests was 49.36%.Conclusions: Stimulating growth hormone testing has a number of limitations but is still needed in some auxological circumstances. We recommend performing the clonidine test first to exclude idiopathic short stature and then the insulin tolerance test for the diagnosis of growth hormone deficiency.

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Section: Discussionmentioning

confidence: 99%

New Insights in Growth Hormone Stimulation Tests Protocols

Armean

Pop

Gherlan

et al. 2018

Acta Medica Marisiensis

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“…A total of 10,000 patients with GHD were simulated individually per treatment arm; 56.0% of the simulated patients were boys, in accordance with the distribution of this population in Spain 31 . Also, 13.6% of them were considered low responders as for population data in our settings 32 .…”

Section: Study Population Characteristicsmentioning

confidence: 99%

Cost-consequence analysis for recombinant human growth hormone treatment administered via different devices in children in Spain

Alcón Sáez,

de Arriba Muñoz,

Latre Gorbe

et al. 2022

EDS

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Objetives: To compare height gain and treatment costs of the treatment with recombinant human growth hormone (r-hGH), administered either by Easypod® —an electronic injection allowing adherence monitoring— or other conventional devices licensed in Spain (non-Easypod®) in children and adolescents with growth hormone deficiency. Methods: The analysis was based on a patient-level simulation model including a decision tree and a Markov model; the Markov model represented the different levels of r-hGH use (adherent, non-adherent, and treatment interruption), whereas the decision tree categorized patients according to their r-hGH response. Model characteristics were adapted to Spanish standards and validated through an expert panel. Average costs per cm gained were estimated for each comparator (Easypod® versus non-Easypod®). Different alternative scenarios were performed to analyze the impact of varying individual parameters on the results. Results: For a mean of 10.4 years of treatment, patients receiving r-hGH via Easypod® gained, on average, 19.1 cm (final height: 165.1 cm) compared with 14.8 cm (final height: 160.8 cm) for the comparators (non-Easypod®); resulting in a difference of 4.3 cm. During treatment, patients on Easypod® arm were adherent for a longer time than comparators (52.4% versus 22.2% of the time), involving greater pharmacological costs for Easypod®. Despite greater costs, Easypod® was associated with the lowest cost per cm gained (€3237.0/cm) amongst comparators (non-Easypod®). Costs per cm gained were also lower for Easypod® than for comparators for all the alternative scenarios. Conclusions: The administration of r-hGH with Easypod® improves height gain through better adherence. Easypod® can be the most efficient treatment compared with the other licensed r-hGH treatments in Spain. Keywords: recombinant human growth hormone, device, adherence, cost-consequence analysis.

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Incidence of diabetes mellitus and neoplasia in Japanese short-statured children treated with growth hormone in the Genetics and Neuroendocrinology of Short Stature International Study (GeNeSIS)

Yokoya

Hasegawa

Ozono

et al. 2017

Clin Pediatr Endocrinol

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Abstract.The primary goal of the Genetics and Neuroendocrinology of Short Stature International Study (GeNeSIS) was to assess the safety and effectiveness of Humatrope®, a GH preparation, in the treatment of pediatric patients with short stature. We report our findings in the GH-treated Japanese pediatric population focusing on the incidence of type 2 diabetes (T2D) and occurrence of neoplasms. A total of 2,345 Japanese patients were assessed for safety. During a mean observation period of 3.2 yr, T2D occurred in 3 patients (0.13%) and slowly progressive insulin-dependent diabetes mellitus (SPIDDM) related to underlying mitochondrial encephalomyopathy, lactic acidosis, and stroke-like episodes (MELAS) in 1 patient (0.04%). Neoplasms were reported in 13 patients (0.56%), including 1 patient with brain tumor (germinoma) and 5 with craniopharyngiomas (4 recurrences); the remainder were benign, typically dermatological, neoplasms. The incidence of diabetes mellitus determined in the study did not differ from previous reports in GH-treated pediatric patients, and there was no apparent increase in the risk of new neoplastic lesions or malignant tumors.

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Safety and efficacy of growth hormone treatment: GeNeSIS study in Spain

Cited by 4 publications

References 30 publications

New Insights in Growth Hormone Stimulation Tests Protocols

New Insights in Growth Hormone Stimulation Tests Protocols

Cost-consequence analysis for recombinant human growth hormone treatment administered via different devices in children in Spain

Incidence of diabetes mellitus and neoplasia in Japanese short-statured children treated with growth hormone in the Genetics and Neuroendocrinology of Short Stature International Study (GeNeSIS)

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