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Dual Delayed-Release Dexlansoprazole for Healing and Maintenance of Healed Erosive Esophagitis: A Safety Study in Adolescents.
Gremse, David; Gold, Benjamin D; Pilmer, Betsy; Hunt, Barbara; Korczowski, Bartosz; Perez, Maria Claudia.
Afiliação
  • Gremse D; Department of Pediatrics, University of South Alabama, 1504 Springhill Avenue, Rm 5309, Mobile, AL, 36604, USA. dgremse@health.southalabama.edu.
  • Gold BD; Children's Center for Digestive Healthcare, Atlanta, GA, USA.
  • Pilmer B; Takeda Development Center Americas, Inc, Deerfield, IL, USA.
  • Hunt B; Takeda Development Center Americas, Inc, Deerfield, IL, USA.
  • Korczowski B; Pediatric Department, State Hospital in Rzeszów, Medical College, University of Rzeszów, Rzeszów, Poland.
  • Perez MC; Takeda Development Center Americas, Inc, Deerfield, IL, USA.
Dig Dis Sci ; 64(2): 493-502, 2019 02.
Article em En | MEDLINE | ID: mdl-30390234
BACKGROUND: In gastroesophageal reflux disease (GERD), the frequency of heartburn symptoms and erosive esophagitis (EE) increases with age in children and adolescents. Proton pump inhibitor, dexlansoprazole, is approved for healing EE of all grades, maintenance of healed EE, relief of heartburn, and treatment of symptomatic non-erosive GERD in patients ≥ 12 years. AIM: To assess safety and efficacy of dexlansoprazole dual delayed-release capsule in healing of EE and maintenance of healed EE in adolescents. METHODS: A multicenter, phase 2, 36-week study was conducted in 62 adolescents (12-17 years) with endoscopically confirmed EE. Patients received dexlansoprazole 60 mg once daily (QD) during open-label healing phase. Those with confirmed healing at week 8 were randomized to dexlansoprazole 30 mg QD or placebo during 16-week, double-blind maintenance phase, with subsequent treatment-free follow-up of ≥ 12 weeks. Primary endpoints were treatment-emergent adverse events (TEAEs) in ≥ 5% of patients during treatment. Secondary endpoints included percentages of patients with healing of EE and with maintenance of healed EE. RESULTS: 88% of patients achieved EE healing, and 61.3% reported a TEAE [headache (12.9%), oropharyngeal pain (8.1%), diarrhea (6.5%), and nasopharyngitis (6.5%)]. During maintenance phase, healing was maintained in 82% and 58% of dexlansoprazole and placebo groups, respectively. 72.0% of dexlansoprazole-treated patients reported TEAEs, which included headache (24.0%), abdominal pain (12.0%), nasopharyngitis (12.0%), pharyngitis (12.0%), sinusitis (12.0%), bronchitis (8.0%), upper respiratory tract infection (8.0%), and insomnia (8.0%); 61.5% experienced a TEAE with placebo. CONCLUSIONS: Dexlansoprazole is safe and efficacious for healing EE and maintenance of healed EE in adolescents.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Esofagite Péptica / Refluxo Gastroesofágico / Inibidores da Bomba de Prótons / Dexlansoprazol Tipo de estudo: Clinical_trials Limite: Adolescent / Child / Female / Humans / Male Idioma: En Ano de publicação: 2019 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Esofagite Péptica / Refluxo Gastroesofágico / Inibidores da Bomba de Prótons / Dexlansoprazol Tipo de estudo: Clinical_trials Limite: Adolescent / Child / Female / Humans / Male Idioma: En Ano de publicação: 2019 Tipo de documento: Article