Cargando…

THU162 Impact On Visual Function And Optic Nerve Morphology In Early Stages Of Growth Hormone Treatment

Disclosure: D.G. Braslavsky: None. A.C. Keselman: None. M.G. Ballerini: None. S. Rosenbrock: None. N. Cappa: None. G. Negrete: None. G. Dech: None. M.G. Ropelato: None. S. Gamio: None. I. Bergada: None. Background Current safety of recombinant human growth hormone (rhGH) treatment arises mainly from...

Descripción completa

Detalles Bibliográficos
Autores principales: Braslavsky, Debora Giselle, Keselman, Ana Claudia, Ballerini, Maria Gabriela, Rosenbrock, Solange, Cappa, Nicolas, Negrete, Gabriel, Dech, Gaston, Ropelato, Maria Gabriela, Gamio, Susana, Bergada, Ignacio
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10555796/
http://dx.doi.org/10.1210/jendso/bvad114.1413
_version_ 1785116737337819136
author Braslavsky, Debora Giselle
Keselman, Ana Claudia
Ballerini, Maria Gabriela
Rosenbrock, Solange
Cappa, Nicolas
Negrete, Gabriel
Dech, Gaston
Ropelato, Maria Gabriela
Gamio, Susana
Bergada, Ignacio
author_facet Braslavsky, Debora Giselle
Keselman, Ana Claudia
Ballerini, Maria Gabriela
Rosenbrock, Solange
Cappa, Nicolas
Negrete, Gabriel
Dech, Gaston
Ropelato, Maria Gabriela
Gamio, Susana
Bergada, Ignacio
author_sort Braslavsky, Debora Giselle
collection PubMed
description Disclosure: D.G. Braslavsky: None. A.C. Keselman: None. M.G. Ballerini: None. S. Rosenbrock: None. N. Cappa: None. G. Negrete: None. G. Dech: None. M.G. Ropelato: None. S. Gamio: None. I. Bergada: None. Background Current safety of recombinant human growth hormone (rhGH) treatment arises mainly from postmarketing surveillance. Headache is a relatively frequent symptom in children under rhGH. Secondary intracranial hypertension (SIH), is an adverse effect (AE), usually occurring within the first 12 weeks of treatment associated to headaches. Permanent visual defects are the most feared complication. Scarce information exists regarding incidence and natural history of visual impairment under rhGH. Aim To evaluate visual impairment and/or optic nerve affection in children throughout early rhGH treatment. Materials and Methods Prospective interventional study conducted from February 2018 to January 2020. Children ≥4 yr who received rhGH treatment for growth hormone deficiency (GHD), 0.16-0.25 mg/kg/w; Turner syndrome (TS), small for gestational age (SGA), 0.33 mg/kg/w and Prader Willy Syndrome (PWS) 1 mg/m(2)/d. Patients were assessed at basal, 1, 3, and 6 months of treatment. Each visit included clinical variables (adherence, auxology, AE, presence of headache), serum IGF1, IGFBP3, glucose, insulin, aldosterone, plasma renin activity, electrolytes and ophthalmologic evaluation [fundoscopy, optical coherence tomography (OCT), retinal nerve fiber layer (RNFL), ganglionic eye complex, ocular ultrasound, intraocular pressure (IOP), autorefractometry, biomicroscopy]. Results Sixty patients were enrolled, 12 GHD, 11 ST, 31 SGA, 3 PWS, 3 TBI (23 females), with a median age of 8.08 yrs (ranged 4.24-15). Median height was -2.25 ± 1.05 SDS. Baseline ophthalmologic evaluation was normal. Abnormal ophthalmological findings were observed in 15/60 (25%). Twelve patients showed changes in OCT, spontaneous recovery occurred in 8, whereas persistence or worsening of RNFL thickening lead to an MRI assessment and lumbar puncture (LP) in 4 patients (1 GHD, 2 SGA, 1 ST); only one referred headache. LP revealed opening pressure of 19, 21, 22 and 30 mmHg, respectively, the latter assumed as SIH at the 1(st) month of treatment. In these four patients, during the findings of ocular abnormalities, they presented a mean IGF1 1.12 ± 1.04 SDS and IGFBP3 -0.02 ± 2.34 SDS. ΔBMI -0.45 ± 0.71 SDS. Prevalence of SIH was 1.6%. All four patients received acetazolamide; median time for RNFL improvement took 4 months (range 4-8). One patient developed post-dural puncture headache. Three had elevated IOP. Along the protocol 19/60 referred headache (26 events). Three of these patients with headaches had abnormal ophthalmological findings (2 mild changes in OCT; 1 elevated IOP). Conclusion We have demonstrated a marked prevalence of abnormal ophthalmological findings upon early rhGH treatment. These observations occurred in the absence of suggestive clinical symptoms, and conversely, headache did not predict SIH. The prevalence of SIH due to rhGH is higher than previously reported. Presentation: Thursday, June 15, 2023
format Online
Article
Text
id pubmed-10555796
institution National Center for Biotechnology Information
language English
publishDate 2023
publisher Oxford University Press
record_format MEDLINE/PubMed
spelling pubmed-105557962023-10-07 THU162 Impact On Visual Function And Optic Nerve Morphology In Early Stages Of Growth Hormone Treatment Braslavsky, Debora Giselle Keselman, Ana Claudia Ballerini, Maria Gabriela Rosenbrock, Solange Cappa, Nicolas Negrete, Gabriel Dech, Gaston Ropelato, Maria Gabriela Gamio, Susana Bergada, Ignacio J Endocr Soc Pediatric Endocrinology Disclosure: D.G. Braslavsky: None. A.C. Keselman: None. M.G. Ballerini: None. S. Rosenbrock: None. N. Cappa: None. G. Negrete: None. G. Dech: None. M.G. Ropelato: None. S. Gamio: None. I. Bergada: None. Background Current safety of recombinant human growth hormone (rhGH) treatment arises mainly from postmarketing surveillance. Headache is a relatively frequent symptom in children under rhGH. Secondary intracranial hypertension (SIH), is an adverse effect (AE), usually occurring within the first 12 weeks of treatment associated to headaches. Permanent visual defects are the most feared complication. Scarce information exists regarding incidence and natural history of visual impairment under rhGH. Aim To evaluate visual impairment and/or optic nerve affection in children throughout early rhGH treatment. Materials and Methods Prospective interventional study conducted from February 2018 to January 2020. Children ≥4 yr who received rhGH treatment for growth hormone deficiency (GHD), 0.16-0.25 mg/kg/w; Turner syndrome (TS), small for gestational age (SGA), 0.33 mg/kg/w and Prader Willy Syndrome (PWS) 1 mg/m(2)/d. Patients were assessed at basal, 1, 3, and 6 months of treatment. Each visit included clinical variables (adherence, auxology, AE, presence of headache), serum IGF1, IGFBP3, glucose, insulin, aldosterone, plasma renin activity, electrolytes and ophthalmologic evaluation [fundoscopy, optical coherence tomography (OCT), retinal nerve fiber layer (RNFL), ganglionic eye complex, ocular ultrasound, intraocular pressure (IOP), autorefractometry, biomicroscopy]. Results Sixty patients were enrolled, 12 GHD, 11 ST, 31 SGA, 3 PWS, 3 TBI (23 females), with a median age of 8.08 yrs (ranged 4.24-15). Median height was -2.25 ± 1.05 SDS. Baseline ophthalmologic evaluation was normal. Abnormal ophthalmological findings were observed in 15/60 (25%). Twelve patients showed changes in OCT, spontaneous recovery occurred in 8, whereas persistence or worsening of RNFL thickening lead to an MRI assessment and lumbar puncture (LP) in 4 patients (1 GHD, 2 SGA, 1 ST); only one referred headache. LP revealed opening pressure of 19, 21, 22 and 30 mmHg, respectively, the latter assumed as SIH at the 1(st) month of treatment. In these four patients, during the findings of ocular abnormalities, they presented a mean IGF1 1.12 ± 1.04 SDS and IGFBP3 -0.02 ± 2.34 SDS. ΔBMI -0.45 ± 0.71 SDS. Prevalence of SIH was 1.6%. All four patients received acetazolamide; median time for RNFL improvement took 4 months (range 4-8). One patient developed post-dural puncture headache. Three had elevated IOP. Along the protocol 19/60 referred headache (26 events). Three of these patients with headaches had abnormal ophthalmological findings (2 mild changes in OCT; 1 elevated IOP). Conclusion We have demonstrated a marked prevalence of abnormal ophthalmological findings upon early rhGH treatment. These observations occurred in the absence of suggestive clinical symptoms, and conversely, headache did not predict SIH. The prevalence of SIH due to rhGH is higher than previously reported. Presentation: Thursday, June 15, 2023 Oxford University Press 2023-10-05 /pmc/articles/PMC10555796/ http://dx.doi.org/10.1210/jendso/bvad114.1413 Text en © The Author(s) 2023. Published by Oxford University Press on behalf of the Endocrine Society. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs licence (https://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited. For commercial re-use, please contact journals.permissions@oup.com
spellingShingle Pediatric Endocrinology
Braslavsky, Debora Giselle
Keselman, Ana Claudia
Ballerini, Maria Gabriela
Rosenbrock, Solange
Cappa, Nicolas
Negrete, Gabriel
Dech, Gaston
Ropelato, Maria Gabriela
Gamio, Susana
Bergada, Ignacio
THU162 Impact On Visual Function And Optic Nerve Morphology In Early Stages Of Growth Hormone Treatment
title THU162 Impact On Visual Function And Optic Nerve Morphology In Early Stages Of Growth Hormone Treatment
title_full THU162 Impact On Visual Function And Optic Nerve Morphology In Early Stages Of Growth Hormone Treatment
title_fullStr THU162 Impact On Visual Function And Optic Nerve Morphology In Early Stages Of Growth Hormone Treatment
title_full_unstemmed THU162 Impact On Visual Function And Optic Nerve Morphology In Early Stages Of Growth Hormone Treatment
title_short THU162 Impact On Visual Function And Optic Nerve Morphology In Early Stages Of Growth Hormone Treatment
title_sort thu162 impact on visual function and optic nerve morphology in early stages of growth hormone treatment
topic Pediatric Endocrinology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10555796/
http://dx.doi.org/10.1210/jendso/bvad114.1413
work_keys_str_mv AT braslavskydeboragiselle thu162impactonvisualfunctionandopticnervemorphologyinearlystagesofgrowthhormonetreatment
AT keselmananaclaudia thu162impactonvisualfunctionandopticnervemorphologyinearlystagesofgrowthhormonetreatment
AT ballerinimariagabriela thu162impactonvisualfunctionandopticnervemorphologyinearlystagesofgrowthhormonetreatment
AT rosenbrocksolange thu162impactonvisualfunctionandopticnervemorphologyinearlystagesofgrowthhormonetreatment
AT cappanicolas thu162impactonvisualfunctionandopticnervemorphologyinearlystagesofgrowthhormonetreatment
AT negretegabriel thu162impactonvisualfunctionandopticnervemorphologyinearlystagesofgrowthhormonetreatment
AT dechgaston thu162impactonvisualfunctionandopticnervemorphologyinearlystagesofgrowthhormonetreatment
AT ropelatomariagabriela thu162impactonvisualfunctionandopticnervemorphologyinearlystagesofgrowthhormonetreatment
AT gamiosusana thu162impactonvisualfunctionandopticnervemorphologyinearlystagesofgrowthhormonetreatment
AT bergadaignacio thu162impactonvisualfunctionandopticnervemorphologyinearlystagesofgrowthhormonetreatment