{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,8]],"date-time":"2026-10-08T23:14:24Z","timestamp":1791501264737,"version":"4.3.4"},"reference-count":12,"publisher":"Springer Science and Business Media LLC","issue":"5","license":[{"start":{"date-parts":[[2020,1,9]],"date-time":"2020-01-09T00:00:00Z","timestamp":1578528000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2020,1,9]],"date-time":"2020-01-09T00:00:00Z","timestamp":1578528000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"FAES FARMA S.A","award":["N\/A"],"award-info":[{"award-number":["N\/A"]}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Eur J Pediatr"],"published-print":{"date-parts":[[2020,5]]},"abstract":"Abstract<\/jats:title>\n \n Bilastine, a second-generation antihistamine, is approved in Europe for the treatment of allergic rhinoconjunctivitis and urticaria in adults and children aged \u2265\u20096\u00a0years. Pharmacokinetic data for children aged 6\u201311\u00a0years were extracted post hoc from a study in which children (2\u201311\u00a0years) with allergic rhinoconjunctivitis or urticaria received oral bilastine (10\u00a0mg\/day). Maximum plasma concentration (\n C<\/jats:italic>\n max<\/jats:sub>\n ) and area under the plasma concentration curve (AUC) data were compared with adult pharmacokinetic data from seven clinical studies (bilastine 20\u00a0mg\/day). Safety data for children aged 6\u201311\u00a0years were extracted post hoc from a phase III randomized controlled trial of children (2\u201311\u00a0years) with allergic rhinoconjunctivitis or chronic urticaria receiving once-daily bilastine 10\u00a0mg or placebo for 12\u00a0weeks. Exposure and\n C<\/jats:italic>\n max<\/jats:sub>\n values were similar for children (6\u201311\u00a0years) and adults: median pediatric\/adult ratios for AUC\n 0\u201324<\/jats:sub>\n and\n C<\/jats:italic>\n max<\/jats:sub>\n were 0.93 and 0.91, respectively. There was no significant difference in the incidence of treatment-emergent adverse in children (6\u201311\u00a0years) receiving bilastine 10\u00a0mg or placebo.\n <\/jats:p>\n \n Conclusion<\/jats:italic>\n : Pharmacokinetic and safety analyses in children aged 6\u201311\u00a0years support the suitability of the pediatric dose of bilastine 10\u00a0mg and confirm that the safety profiles of bilastine and placebo are similar.\n \n \n \n \n \n What is Known:<\/jats:bold>\n \u2022\n Bilastine, a second-generation antihistamine, is approved in Europe for the treatment of allergic rhinoconjunctivitis and urticaria in adults (20\u00a0mg\/day) and children aged \u2265\u20096\u00a0years (10\u00a0mg\/day).<\/jats:italic>\n \u2022\n An ontogenic model based on adult data and pharmacokinetic\/pharmacodynamic simulations supported the selection of a bilastine dose of 10\u00a0mg\/day in children aged 2\u201311\u00a0years. Bilastine 10\u00a0mg\/day was shown to have a safety profile similar to that of placebo in a large phase III randomized clinical trial in children aged 2\u201311\u00a0years.<\/jats:italic>\n <\/jats:td>\n <\/jats:tr>\n \n \n What is New:<\/jats:bold>\n \u2022\n As bilastine is approved in Europe for children aged \u22656\u00a0years, the current study reports the results of two post hoc analyses of pharmacokinetic and safety data in children aged 6\u201311\u00a0years.<\/jats:italic>\n \u2022\n Analysis of pharmacokinetic and safety data in children aged 6\u201311\u00a0years supports the suitability of the pediatric dose of bilastine 10\u00a0mg and confirms that its safety profile is similar to that of placebo.<\/jats:italic>\n <\/jats:td>\n <\/jats:tr>\n <\/jats:tbody>\n <\/jats:table>\n <\/jats:table-wrap>\n <\/jats:p>","DOI":"10.1007\/s00431-019-03559-6","type":"journal-article","created":{"date-parts":[[2020,1,9]],"date-time":"2020-01-09T02:12:42Z","timestamp":1578535962000},"page":"801-805","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":13,"title":["Pharmacokinetics and safety of bilastine in children aged 6 to 11\u00a0years with allergic rhinoconjunctivitis or chronic urticaria"],"prefix":"10.1007","volume":"179","author":[{"given":"M\u00f3nica","family":"Rodr\u00edguez","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Valvanera","family":"Vozmediano","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aintzane","family":"Garc\u00eda-Bea","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zolt\u00e1n","family":"Nov\u00e1k","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anah\u00ed","family":"Y\u00e1\u00f1ez","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cristina","family":"Campo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Luis","family":"Labeaga","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2020,1,9]]},"reference":[{"key":"3559_CR1","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1111\/j.1398-9995.2010.02404.x","volume":"65","author":"C Bachert","year":"2010","unstructured":"Bachert C, Kuna P, Zuberbier T (2010) Bilastine in allergic rhinoconjunctivitis and urticaria. 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A. MR and VV have no conflicts of interest other than receiving funding from FAES FARMA, S.A., for designing the PK trial and conducting the modeling and simulation analysis. The remaining authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"The study was approved by the Pediatric Committee of the European Medicines Agency (PDCO) and conducted in accordance with the principles of the Declaration of Helsinki. The study was conducted at eight sites in four countries (Australia, Germany, Spain, and Sweden), all of which had received previous approval by the corresponding Institutional Review Board.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}},{"value":"Parents provided written consent and children, when considered to be old enough, provided assent for participation.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Informed consent"}}]}}