{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,19]],"date-time":"2026-09-19T12:14:32Z","timestamp":1789820072309,"version":"4.0.1"},"reference-count":27,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2016,5,5]],"date-time":"2016-05-05T00:00:00Z","timestamp":1462406400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"FAES FARMA, S.A"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pediatric Allergy Immunology"],"published-print":{"date-parts":[[2016,8]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Regulations on medicinal products for paediatric use require that pharmacokinetics and safety be characterized specifically in the paediatric population. A previous study established that a 10\u2010mg dose of bilastine in children aged 2 to &lt;12 years provided an equivalent systemic exposure as 20 mg in adults. The current study assessed the safety and tolerability of bilastine 10 mg in children with allergic rhinoconjunctivitis and chronic urticaria.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      In this phase\n                      <jats:styled-content style=\"fixed-case\">III<\/jats:styled-content>\n                      , multicentre, double\u2010blind study, children were randomized to once\u2010daily treatment with bilastine 10\u2010mg oral dispersible table (n = 260) or placebo (n = 249) for 12 weeks. Safety evaluations included treatment\u2010emergent adverse events (\n                      <jats:styled-content style=\"fixed-case\">TEAE<\/jats:styled-content>\n                      s), laboratory tests, cardiac safety (\n                      <jats:styled-content style=\"fixed-case\">ECG<\/jats:styled-content>\n                      recordings) and somnolence\/sedation using the Pediatric Sleep Questionnaire (\n                      <jats:styled-content style=\"fixed-case\">PSQ<\/jats:styled-content>\n                      ).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      The primary hypothesis of non\u2010inferiority between bilastine 10 mg and placebo was demonstrated on the basis of a near\u2010equivalent proportion of children in each treatment arm without\n                      <jats:styled-content style=\"fixed-case\">TEAE<\/jats:styled-content>\n                      s during 12 weeks' treatment (31.5 vs. 32.5%). No clinically relevant differences between bilastine 10 mg and placebo were observed from baseline to study end for\n                      <jats:styled-content style=\"fixed-case\">TEAE<\/jats:styled-content>\n                      s or related\n                      <jats:styled-content style=\"fixed-case\">TEAE<\/jats:styled-content>\n                      s,\n                      <jats:styled-content style=\"fixed-case\">ECG<\/jats:styled-content>\n                      parameters and\n                      <jats:styled-content style=\"fixed-case\">PSQ<\/jats:styled-content>\n                      scores. The majority of\n                      <jats:styled-content style=\"fixed-case\">TEAE<\/jats:styled-content>\n                      s were mild or moderate in intensity.\n                      <jats:styled-content style=\"fixed-case\">TEAE<\/jats:styled-content>\n                      s led to discontinuation of two patients treated with bilastine 10 mg and one patient treated with placebo.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Bilastine 10 mg had a safety and tolerability profile similar to that of placebo in children aged 2 to &lt;12 years with allergic rhinoconjunctivitis or chronic urticaria.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/pai.12555","type":"journal-article","created":{"date-parts":[[2016,2,26]],"date-time":"2016-02-26T10:48:54Z","timestamp":1456483734000},"page":"493-498","source":"Crossref","is-referenced-by-count":41,"title":["Safety and tolerability of bilastine 10 mg administered for 12 weeks in children with allergic diseases"],"prefix":"10.1111","volume":"27","author":[{"given":"Zolt\u00e1n","family":"Nov\u00e1k","sequence":"first","affiliation":[{"name":"Aranyklinika Eg\u00e9szs\u00e9g\u00fcgyi \u00e9s Innov\u00e1ci\u00f3s Kft. Szeged Hungary"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anah\u00ed","family":"Y\u00e1\u00f1ez","sequence":"additional","affiliation":[{"name":"INAER\u2010Investigaciones en Alergia y Enfermedades Respiratorias Buenos Aires Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ildik\u00f3","family":"Kiss","sequence":"additional","affiliation":[{"name":"Children Department Zala Megyei K\u00f3rh\u00e1z Zalaegerszeg Hungary"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Piotr","family":"Kuna","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Asthma and Allergy Medical University of Lodz Lodz Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Miguel","family":"Tortajada\u2010Girb\u00e9s","sequence":"additional","affiliation":[{"name":"Pediatric Department Hospital Universitario Dr. Peset Valencia Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rom\u00e1n","family":"Valiente","sequence":"additional","affiliation":[{"name":"Clinical Research Department FAES FARMA S. 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Leioa Bizkaia Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"the \u201cBilastine Paediatric Safety Study Group\u201d","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2016,5,5]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaci.2009.05.013"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/cea.12494"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1186\/s40413-014-0052-x"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1398-9995.2007.01620.x"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/all.12313"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.2165\/9884960-000000000-00000"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1136\/archdischild-2013-304446"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1111\/pai.12036"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1186\/2045-7022-4-S1-O10"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMra035092"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2222.2009.03257.x"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1398-9995.2008.01813.x"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00011-009-0117-4"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1398-9995.2009.02217.x"},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.1177\/0091270011407191"},{"key":"e_1_2_8_17_1","doi-asserted-by":"publisher","DOI":"10.2165\/11599270-000000000-00000"},{"key":"e_1_2_8_18_1","doi-asserted-by":"publisher","DOI":"10.2165\/00126839-200506060-00005"},{"key":"e_1_2_8_19_1","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.12421"},{"key":"e_1_2_8_20_1","doi-asserted-by":"publisher","DOI":"10.3109\/01480545.2012.682651"},{"key":"e_1_2_8_21_1","unstructured":"WahnU ValienteR VozmedianoV et al.10 mg of oral bilastine in 2 to 11 years old children has similar exposure to the adult therapeutic dose (20 mg). 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