{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,29]],"date-time":"2026-10-29T17:34:47Z","timestamp":1793295287443,"version":"4.5.0"},"reference-count":39,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2024,1,1]],"date-time":"2024-01-01T00:00:00Z","timestamp":1704067200000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100014756","name":"HEXAL AG","doi-asserted-by":"crossref","id":[{"id":"10.13039\/501100014756","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Therapeutic Advances in Endocrinology"],"published-print":{"date-parts":[[2024,1]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>Recombinant human growth hormone (rhGH, somatropin) therapy is approved in children with Prader\u2013Willi syndrome (PWS).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objectives:<\/jats:title>\n                    <jats:p>\n                      To report safety and effectiveness data for children with PWS treated with biosimilar rhGH (Omnitrope\n                      <jats:sup>\u00ae<\/jats:sup>\n                      , Sandoz) in the PAtients TReated with Omnitrope (PATRO) Children study.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design:<\/jats:title>\n                    <jats:p>PATRO Children was a multicenter, non-interventional, postmarketing surveillance study.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>Children with PWS received Omnitrope according to standard clinical practice. Adverse events (AEs) were monitored for the duration of Omnitrope treatment. Effectiveness outcomes were also assessed, including height standard deviation (SD) scores (HSDS).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>As of July 2020 (study completion), 235 patients with PWS had been enrolled. At baseline, 95.7% ( n\u2009=\u2009225) of patients were prepubertal and 86.4% ( n\u2009=\u2009203) were rhGH treatment-na\u00efve. At analysis, the median (range) treatment duration in the study was 56.8 (2.9\u2013155.8)\u2009months. AEs were reported in 192 patients (81.7%) and were suspected as treatment-related in 39 patients (16.6%). Serious AEs (SAEs) were reported in 96 patients (40.9%) and were suspected as treatment-related in 22 patients (9.4%). The most frequent treatment-related SAEs were sleep apnea syndrome ( n\u2009=\u200911; 4.7%), tonsillar hypertrophy ( n\u2009=\u20094; 1.7%), and adenoidal hypertrophy ( n\u2009=\u20094; 1.7%). Development of scoliosis was considered treatment-related in two patients; development of impaired glucose tolerance in one patient and type 2 diabetes mellitus in another patient were considered treatment-related. Effectiveness outcomes were primarily assessed in 153 patients who completed 3\u2009years of treatment. Among the 151 prepubertal patients (135 treatment-na\u00efve), mean (SD) change from baseline in HSDS after 3\u2009years was +1.50 (1.07) across all patients and +1.57 (1.07) for treatment-na\u00efve patients.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>These data suggest that biosimilar rhGH is well tolerated and effective in patients with PWS managed in real-life clinical practice. Patients with PWS should continue to be closely monitored for well-known safety issues (including respiratory, sleep, and glucose metabolism disorders, and scoliosis) during rhGH treatment.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/20420188241264343","type":"journal-article","created":{"date-parts":[[2024,9,30]],"date-time":"2024-09-30T04:35:36Z","timestamp":1727670936000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":11,"title":["Growth hormone treatment in children with Prader\u2013Willi syndrome: safety and effectiveness data from the PATRO Children study"],"prefix":"10.1177","volume":"15","author":[{"given":"Constanze","family":"L\u00e4mmer","sequence":"first","affiliation":[{"name":"Department of Pediatrics, KJF Josefinum, Joseph-Mayer-Stra\u00dfe 1, Augsburg 86154, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Philippe","family":"Backeljauw","sequence":"additional","affiliation":[{"name":"Cincinnati Children\u2019s Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, OH, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maite","family":"Tauber","sequence":"additional","affiliation":[{"name":"Unit\u00e9 d\u2019Endocrinologie, Ob\u00e9sit\u00e9, Maladies Osseuses, G\u00e9n\u00e9tique et Gyn\u00e9cologie M\u00e9dicale, Centre de R\u00e9f\u00e9rence du Syndrome de Prader\u2013Willi et Autres Syndrome avec Ob\u00e9sit\u00e9 et Troubles du Comportement Alimentaire, H\u00f4pital des Enfants, Toulouse, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shankar","family":"Kanumakala","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Royal Alexandra Children\u2019s Hospital, University Hospitals Sussex NHS Foundation Trust, Brighton, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sandro","family":"Loche","sequence":"additional","affiliation":[{"name":"SSD Endocrinologia Pediatrica e Centro, Screening Neonatale, Ospedale Pediatrico Microcitemico \u2018A. Cao\u2019, Cagliari, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karl","family":"Otfried Schwab","sequence":"additional","affiliation":[{"name":"Department of General Pediatrics, Adolescent Medicine and Neonatology, Faculty of Medicine, Medical Centre, University of Freiburg, Freiburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roland","family":"Pf\u00e4ffle","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, University of Leipzig, Leipzig, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charlotte","family":"H\u00f6ybye","sequence":"additional","affiliation":[{"name":"Department of Endocrinology, Karolinska University Hospital, Stockholm, Sweden"},{"name":"Department of Molecular Medicine and Surgery, Karolinska Institute, Stockholm, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elena","family":"Lundberg","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Institution of Clinical Science, Ume\u00e5 University, Ume\u00e5, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jovanna","family":"Dahlgren","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, G\u00f6teborg Pediatric Growth Research Center, Institute of Clinical Sciences, University of Gothenburg, Gothenburg, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna E.","family":"Ek","sequence":"additional","affiliation":[{"name":"Division of Pediatrics, Intervention and Technology, Department of Clinical Science, Karolinska Institute, Stockholm, Sweden"},{"name":"Pediatric Endocrinology and Metabolic Diseases, Karolinska University Hospital, Stockholm, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tadej","family":"Battelino","sequence":"additional","affiliation":[{"name":"Department of Paediatric Endocrinology, Diabetes and Metabolic Diseases, Faculty of Medicine, University Children\u2019s Hospital, University Medical Centre, University of Ljubljana, Ljubljana, Slovenia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Berit","family":"Kristr\u00f6m","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Institution of Clinical Science, Ume\u00e5 University, Ume\u00e5, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Altaher","family":"Esmael","sequence":"additional","affiliation":[{"name":"HEXAL AG (a Sandoz Company), Holzkirchen, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Markus","family":"Zabransky","sequence":"additional","affiliation":[{"name":"HEXAL AG (a Sandoz Company), Holzkirchen, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2024,9,29]]},"reference":[{"key":"bibr1-20420188241264343","doi-asserted-by":"publisher","DOI":"10.2174\/1573396315666190716120925"},{"key":"bibr2-20420188241264343","doi-asserted-by":"publisher","DOI":"10.2147\/TCRM.S70068"},{"key":"bibr3-20420188241264343","doi-asserted-by":"publisher","DOI":"10.1007\/s40618-015-0312-9"},{"key":"bibr4-20420188241264343","doi-asserted-by":"publisher","DOI":"10.1016\/S2213-8587(21)00002-4"},{"key":"bibr5-20420188241264343","doi-asserted-by":"publisher","DOI":"10.1038\/gim.0b013e31822bead0"},{"key":"bibr6-20420188241264343","doi-asserted-by":"publisher","DOI":"10.1590\/1984-0462\/;2018;36;3;00003"},{"key":"bibr7-20420188241264343","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0101012"},{"key":"bibr8-20420188241264343","doi-asserted-by":"publisher","DOI":"10.1093\/ajcn\/65.5.1369"},{"key":"bibr9-20420188241264343","doi-asserted-by":"publisher","DOI":"10.1016\/j.yapd.2016.04.005"},{"key":"bibr10-20420188241264343","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2265.2008.03228.x"},{"key":"bibr11-20420188241264343","doi-asserted-by":"publisher","DOI":"10.1210\/jc.2009-0656"},{"key":"bibr12-20420188241264343","doi-asserted-by":"publisher","DOI":"10.1210\/jcem.87.4.8414"},{"key":"bibr13-20420188241264343","doi-asserted-by":"publisher","DOI":"10.1210\/jc.2016-2962"},{"key":"bibr14-20420188241264343","doi-asserted-by":"publisher","DOI":"10.1186\/s13633-020-00090-6"},{"key":"bibr15-20420188241264343","doi-asserted-by":"publisher","DOI":"10.1210\/jc.2013-2012"},{"key":"bibr16-20420188241264343","doi-asserted-by":"publisher","DOI":"10.1002\/ajmg.a.32131"},{"key":"bibr17-20420188241264343","first-page":"138","volume":"14","author":"Tauber M","year":"2016","journal-title":"Pediatr Endocrinol Rev"},{"key":"bibr18-20420188241264343","unstructured":"European Medicines Agency. 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