{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,19]],"date-time":"2026-09-19T16:18:34Z","timestamp":1789834714479,"version":"4.0.1"},"reference-count":33,"publisher":"The Endocrine Society","issue":"1","license":[{"start":{"date-parts":[[2023,8,14]],"date-time":"2023-08-14T00:00:00Z","timestamp":1691971200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100001254","name":"Ipsen","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100001254","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2023,12,21]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Context<\/jats:title>\n                  <jats:p>The European Increlex\u00ae Growth Forum Database (Eu-IGFD) is an ongoing surveillance registry (NCT00903110) established to collect long-term safety and effectiveness data on the use of recombinant human insulin-like growth factor-1 (rhIGF-1, mecasermin, Increlex) for the treatment of children\/adolescents with severe primary insulin-like growth factor-1 deficiency (SPIGFD).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Objective<\/jats:title>\n                  <jats:p>This analysis of Eu-IGFD data aimed to identify the frequency and predictive factors for hypoglycemia adverse events (AEs) in children treated with rhIGF-1.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Data were collected from December 2008 to May 2021. Logistic regression was performed to identify predictive risk factors for treatment-induced hypoglycemia AEs. Odds ratios (ORs) are presented with 95% CIs for each factor.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>In total, 306 patients were enrolled in the registry; 84.6% were diagnosed with SPIGFD. Patients who experienced \u2265 1 hypoglycemia AE (n = 80) compared with those with no hypoglycemia AEs (n = 224) had a lower mean age at treatment start (8.7 years vs 9.8 years), a more frequent diagnosis of Laron syndrome (27.5% vs 10.3%), and a history of hypoglycemia (18.8% vs 4.5%). Prior history of hypoglycemia (OR 0.25; 95% CI: [0.11; 0.61]; P = .002) and Laron syndrome diagnosis (OR 0.36; 95% CI: [0.18; 0.72]; P = .004) predicted future hypoglycemia AEs. Total hypoglycemia AEs per patient per treatment year was 0.11 and total serious hypoglycemia AEs per patient per treatment year was 0.01.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>Hypoglycemia occurs more frequently in patients with prior history of hypoglycemia and\/or Laron syndrome compared with patients without these risk factors, and these patients should be carefully monitored for this AE throughout treatment.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1210\/clinem\/dgad479","type":"journal-article","created":{"date-parts":[[2023,8,14]],"date-time":"2023-08-14T19:27:35Z","timestamp":1692041255000},"page":"46-56","source":"Crossref","is-referenced-by-count":8,"title":["Frequency and Predictive Factors of Hypoglycemia in Patients Treated With rhIGF-1: Data From the Eu-IGFD Registry"],"prefix":"10.1210","volume":"109","author":[{"given":"Peter","family":"Bang","sequence":"first","affiliation":[{"name":"Division of Pediatrics, Department of Biomedical and Clinical Sciences, Faculty of Health Sciences, Link\u00f6ping University , 581 83 Link\u00f6ping , Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michel","family":"Polak","sequence":"additional","affiliation":[{"name":"Department of Pediatric Endocrinology, Gynaecology, and Diabetology, Assistance Publique\u2014H\u00f4pitaux de Paris, H\u00f4pital Universitaire Necker-Enfants Malades , 75015 Paris , France"},{"name":"IMAGINE Institute, INSERM U1016, France University of Paris Cit\u00e9 , 75015 Paris , France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6316-5342","authenticated-orcid":false,"given":"Artur","family":"Bossowski","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Endocrinology, Diabetology with Cardiology Division, Medical University of Bia\u0142ystok , 15-274 Bia\u0142ystok , Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7183-5238","authenticated-orcid":false,"given":"Mohamad","family":"Maghnie","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, IRCCS Istituto Giannina Gaslini , 16100 Genova , Italy"},{"name":"Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health University of Genova , 16132 Genova , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5826-0276","authenticated-orcid":false,"given":"Jes\u00fas","family":"Argente","sequence":"additional","affiliation":[{"name":"Department of Endocrinology, Hospital Infantil Universitario Ni\u00f1o Jes\u00fas, Instituto de Investigaci\u00f3n La Princesa , 28009 Madrid , Spain"},{"name":"Department of Pediatrics, Universidad Aut\u00f3noma de Madrid , 28029 Madrid , Spain"},{"name":"Centro de Investigaci\u00f3n Biom\u00e9dica en Red de la Fisiopatolog\u00eda (CIBER) de Fisiopatolog\u00eda de Obesidad y Nutrici\u00f3n, Instituto de Salud Carlos III , 28029 Madrid , Spain"},{"name":"IMDEA Food Institute , 28049 Madrid , Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3027-9105","authenticated-orcid":false,"given":"Marta","family":"Ramon-Krauel","sequence":"additional","affiliation":[{"name":"Hospital Sant Joan de D\u00e9u, Institut de Recerca Sant Joan de D\u00e9u , 08950 Barcelona , Spain"},{"name":"Centro de Investigaci\u00f3n Biom\u00e9dica en Red de Diabetes y Enfermedades Metab\u00f3licas Asociadas (CIBERDEM), Instituto de Salud Carlos III , 28029 Madrid , Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Caroline","family":"Sert","sequence":"additional","affiliation":[{"name":"Ipsen Pharma , 92100 Boulogne-Billancourt , 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