Dexlansoprazole found to be effective and safe to treat erosive esophagitis

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Created On: 30/03/2021

Dexlansoprazole found to be effective and safe to treat erosive esophagitis

A phase II, 36-week, multicenter trial was performed to investigate efficacy and safety of dexlansoprazole (proton pump inhibitor) dual delayed-release capsule to heal erosive esophagitis and maintain healed erosive esophagitis in 62 adolescents (12–17 years) with endoscopically confirmed erosive esophagitis.

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Key take away

Dexlansoprazole was found to be effective and safe to heal erosive esophagitis and maintain healed erosive esophagitis in adolescents.

Background

Method

During the open-label healing phase, participants were given dexlansoprazole (60 mg once daily). Participants having confirmed healing at the 8th week were randomly assigned to dexlansoprazole (30 mg once daily) or placebo during the double-blind, 16-week, maintenance phase with subsequent therapy-free follow-up of ≥ 12 weeks.

The treatment-emergent adverse events (TEAEs) in ≥ 5% of participants during the therapy was the major outcome. The proportion of individuals with the healing of erosive esophagitis and with the maintenance of healed erosive esophagitis were the secondary outcomes.

Result

In total, 88% of participants attained erosive esophagitis healing, and 61.3% of participants reported a TEAE [diarrhea (6.5%), headache (12.9%), nasopharyngitis (6.5%), and oropharyngeal pain (8.1%)]. During the maintenance phase, the percentage of patients in which healing was maintained and the proportion of patients witnessing TEAEs is shown in the below table.

Dexlansoprazole-emergent side effects included insomnia (8 %), headache (24 %), pharyngitis (12 %), abdominal pain (12 %), bronchitis (8 %), nasopharyngitis (12 %), sinusitis (12 %), and upper respiratory tract infection (8.0%).