CONTEXT: Safety concerns regarding premature mortality, diabetes, neoplasia and cerebrovascular disease in association with growth hormone (GH) therapy have been raised. OBJECTIVE: To assess incidence of key safety outcomes. DESIGN: Prospective, multinational, observational study (1999-2015). SETTING: 22,311 GH-treated children from 827 investigative sites in 30 countries. PATIENTS: Children with growth disorders. INTERVENTIONS: GH treatment. MAIN OUTCOME MEASURES: Standardized mortality (SMR) and incidence (SIR) ratios with 95% confidence intervals (CI) for mortality, diabetes, and primary cancer, using general population registries. RESULTS: Predominant short stature diagnoses were GH deficiency (63%), idiopathic short stature (13%), and Turner syndrome (8%), with mean±SD follow-up of 4.2±3.2 years (∼92,000 person-years [PY]). Forty-two deaths occurred in patients with follow-up, with SMR (95% CI) of 0.61 (0.44-0.82); the SMR was elevated for patients with cancer-related organic GH deficiency (5.87 [3.21-9.85]). Based on 18 cases, Type 2 diabetes (T2DM) risk was elevated (SIR 3.77 [2.24-5.96]), but 72% had risk factors. In patients without cancer history, 14 primary cancers were observed (SIR 0.71 [0.39-1.20]). Second neoplasms occurred in 31/622 (5.0%) cancer survivors (10.7 [7.5-15.2] cases/1000 PY), and intracranial tumor recurrences in 67/823 (8.1%) tumor survivors (16.9 [13.3-21.5] cases/1000 PY). All 3 hemorrhagic stroke cases had risk factors. CONCLUSIONS: GeNeSIS data support the favourable safety profile of pediatric GH treatment. Overall risk for death or primary cancer was not elevated in GH-treated children, and no hemorrhagic strokes occurred in patients without risk factors. T2DM incidence was elevated compared to the general population, but most cases had diabetes risk factors.
|Data di pubblicazione:||2019|
|Titolo:||Safety outcomes during pediatric GH therapy: final results from the prospective GeNeSIS observational program|
|Autore/i:||Child, Cj; Zimmermann, Ag; Chrousos, Gp; Cummings, E; Deal, Cl; Hasegawa, T; Jia, N; Lawrence, S; Linglart, A; Loche, S; Maghnie, M; Pérez Sánchez, J; Polak, M; Predieri, B; Richter-Unruh, A; Rosenfeld, Rg; Yeste, D; Yorifuji, T; Blum, Wf|
|Digital Object Identifier (DOI):||10.1210/jc.2018-01189|
|Codice identificativo ISI:||WOS:000462864100022|
|Codice identificativo Scopus:||2-s2.0-85058922929|
|Codice identificativo Pubmed:||30219920|
|Citazione:||Safety outcomes during pediatric GH therapy: final results from the prospective GeNeSIS observational program / Child, Cj; Zimmermann, Ag; Chrousos, Gp; Cummings, E; Deal, Cl; Hasegawa, T; Jia, N; Lawrence, S; Linglart, A; Loche, S; Maghnie, M; Pérez Sánchez, J; Polak, M; Predieri, B; Richter-Unruh, A; Rosenfeld, Rg; Yeste, D; Yorifuji, T; Blum, Wf. - In: THE JOURNAL OF CLINICAL ENDOCRINOLOGY AND METABOLISM. - ISSN 0021-972X. - 104:2(2019), pp. 379-389.|
|Tipologia||Articolo su rivista|
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