{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,8]],"date-time":"2026-06-08T13:09:29Z","timestamp":1780924169217,"version":"3.54.1"},"reference-count":20,"publisher":"Walter de Gruyter GmbH","issue":"2","funder":[{"name":"Uni-Pharma"},{"name":"Uni-PharmaNone","award":["EudraCT 2013-002139-15"],"award-info":[{"award-number":["EudraCT 2013-002139-15"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2022,2,23]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec id=\"j_jpem-2021-0458_abs_001\">\n                  <jats:title>Objectives<\/jats:title>\n                  <jats:p>The aim of the current prospective randomized control study was to assess efficacy, safety, and non-inferiority of a new liquid L-thyroxine formulation dissolved in glycerol and water (T4<jats:sup>\u00ae<\/jats:sup> drops, produced by a Greek pharmaceutical Company, Uni-Pharma, Athens, Greece) in comparison to the standard Tablets form (T4<jats:sup>\u00ae<\/jats:sup> tablets, Uni-Pharma, Athens, Greece) in the substitutive treatment of children with congenital hypothyroidism (CH).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec id=\"j_jpem-2021-0458_abs_002\">\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Thirty-nine children with CH, aged 3\u201312\u00a0years old, were enrolled in the study, after parental Informed Consent has been obtained, while three patients were lost from follow-up. At baseline, all participants had normal thyroid-stimulating hormone (TSH) and Free T4 values. Patients were randomly subdivided according to the assigned treatment in Group A (n=17)-Tablet Form and Group B (n=19)-Liquid Form. TSH and Free T4 levels were evaluated at 0, 2, 4, and 6\u00a0months.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec id=\"j_jpem-2021-0458_abs_003\">\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>TSH values showed a statistically significant difference (p=0.017) between groups only at six\u00a0months (Group A having higher TSH levels than Group B, albeit within the normal range), while Free T4 levels had no statistical difference throughout the six\u00a0month study period and were always within the normal range. Moreover, dose adjustments were more frequent in Group A (p=0.038) during the six\u00a0months. Liquid L-thyroxine substitutive treatment exhibited no statistically significant adverse effects in comparison to the widely used tablets.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec id=\"j_jpem-2021-0458_abs_004\">\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Levothyroxine (LT4) as liquid solution formulation is safe and noninferior to the widely used <jats:sc>L<\/jats:sc>-thyroxine Tablets, with less need for dose adjustment, and can therefore be safely used in the treatment of children with CH.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1515\/jpem-2021-0458","type":"journal-article","created":{"date-parts":[[2021,10,15]],"date-time":"2021-10-15T21:48:56Z","timestamp":1634334536000},"page":"239-247","source":"Crossref","is-referenced-by-count":8,"title":["Non-inferiority of liquid thyroxine in comparison to tablets formulation in the treatment of children with congenital hypothyroidism"],"prefix":"10.1515","volume":"35","author":[{"given":"Flora","family":"Tzifi","sequence":"first","affiliation":[{"name":"Division of Endocrinology, Diabetes and Metabolism, First Department of Pediatrics Medical School , National and Kapodistrian University of Athens, \u201cAghia Sophia\u201d Children\u2019s Hospital , Athens , Greece"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexandra","family":"Iliadi","sequence":"additional","affiliation":[{"name":"Institute of Child Health, \u201cAghia Sophia\u201d Children\u2019s Hospital , Athens , Greece"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antonis","family":"Voutetakis","sequence":"additional","affiliation":[{"name":"Division of Endocrinology, Diabetes and Metabolism, First Department of Pediatrics Medical School , National and Kapodistrian University of Athens, \u201cAghia Sophia\u201d Children\u2019s Hospital , Athens , Greece"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dimitris","family":"Platis","sequence":"additional","affiliation":[{"name":"Institute of Child Health, \u201cAghia Sophia\u201d Children\u2019s Hospital , Athens , Greece"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Panagiotis","family":"Girginoudis","sequence":"additional","affiliation":[{"name":"Institute of Child Health, \u201cAghia Sophia\u201d Children\u2019s Hospital , Athens , Greece"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christina","family":"Kanaka-Gantenbein","sequence":"additional","affiliation":[{"name":"Division of Endocrinology, Diabetes and Metabolism, First Department of Pediatrics Medical School , National and Kapodistrian University of Athens, \u201cAghia Sophia\u201d Children\u2019s Hospital , Athens , Greece"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"374","published-online":{"date-parts":[[2021,10,18]]},"reference":[{"key":"2023041309511478689_j_jpem-2021-0458_ref_001","doi-asserted-by":"crossref","unstructured":"Bauer, AJ, Wassner, AJ. 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