{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["183(5)"],"submitter":["Ivy D"],"pubmed_abstract":["This open-label, extension study assessed long-term safety, tolerability, and efficacy of ambrisentan in a pediatric population (age 8- < 18 years) with pulmonary arterial hypertension (PAH). Following completion of a 6-month, randomized study, participants entered the long-term extension at individualized ambrisentan dosages (2.5/5/7.5 or 10 mg/day). Safety assessments included adverse events (AEs), AEs of special interest, and serious AEs (SAEs); efficacy outcomes included 6-min walking distance (6MWD) and World Health Organization functional class (WHO FC). Thirty-eight of 41 (93%) randomized study participants entered the extension; 21 (55%) completed (reaching age 18 years). Most participants received concomitant phosphodiesterase-5 inhibitors (n = 25/38, 66%). Median ambrisentan expo"],"journal":["European journal of pediatrics"],"pagination":["2141-2153"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC11035402"],"repository":["biostudies-literature"],"pubmed_title":["Long-term safety and tolerability of ambrisentan treatment for pediatric patients with pulmonary arterial hypertension: An open-label extension study."],"pmcid":["PMC11035402"],"pubmed_authors":["Juaneda-Simian E","Lukas MA","Machlitt-Northen S","Berger RMF","Beghetti M","Scott N","Ivy D","Ravindranath R","Narita J"],"additional_accession":[]},"is_claimable":false,"name":"Long-term safety and tolerability of ambrisentan treatment for pediatric patients with pulmonary arterial hypertension: An open-label extension study.","description":"This open-label, extension study assessed long-term safety, tolerability, and efficacy of ambrisentan in a pediatric population (age 8- < 18 years) with pulmonary arterial hypertension (PAH). Following completion of a 6-month, randomized study, participants entered the long-term extension at individualized ambrisentan dosages (2.5/5/7.5 or 10 mg/day). Safety assessments included adverse events (AEs), AEs of special interest, and serious AEs (SAEs); efficacy outcomes included 6-min walking distance (6MWD) and World Health Organization functional class (WHO FC). Thirty-eight of 41 (93%) randomized study participants entered the extension; 21 (55%) completed (reaching age 18 years). Most participants received concomitant phosphodiesterase-5 inhibitors (n = 25/38, 66%). Median ambrisentan expo","dates":{"release":"2024-01-01T00:00:00Z","publication":"2024 May","modification":"2026-07-15T10:45:10.527Z","creation":"2026-07-03T03:14:13.653Z"},"accession":"S-EPMC11035402","cross_references":{"pubmed":["38366267"],"doi":["10.1007/s00431-024-05446-1"]}}