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Dual Delayed-Release Dexlansoprazole for Healing and Maintenance of Healed Erosive Esophagitis: A Safety Study in Adolescents.

ABSTRACT: 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.

SUBMITTER: Gremse D

PROVIDER: S-EPMC6514063 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature

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Dual Delayed-Release Dexlansoprazole for Healing and Maintenance of Healed Erosive Esophagitis: A Safety Study in Adolescents.

Gremse David D Gold Benjamin D BD Pilmer Betsy B Hunt Barbara B Korczowski Bartosz B Perez Maria Claudia MC

Digestive diseases and sciences 20181102 2

<h4>Background</h4>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.<h4>Aim</h4>To assess safety and efficacy of dexlansoprazole dual delayed-release capsule in healing of EE and maintenance of h ...[more]

PMID: 30390234

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Project description:AimTo compare vonoprazan 10 and 20 mg vs lansoprazole 15 mg as maintenance therapy in healed erosive esophagitis (EE).MethodsA total of 607 patients aged ≥ 20 years, with endoscopically-confirmed healed EE following 8 wk of treatment with vonoprazan 20 mg once daily, were randomized 1:1:1 to receive lansoprazole 15 mg (n = 201), vonoprazan 10 mg (n = 202), or vonoprazan 20 mg (n = 204), once daily. The primary endpoint of the study was the rate of endoscopically-confirmed EE recurrence during a 24-wk maintenance period. The secondary endpoint was the EE recurrence rate at Week 12 during maintenance treatment. Additional efficacy endpoints included the incidence of heartburn and acid reflux, and the EE healing rate 4 wk after the initiation of maintenance treatment. Safety endpoints comprised adverse events (AEs), vital signs, electrocardiogram findings, clinical laboratory results, serum gastrin and pepsinogen I/II levels, and gastric mucosa histopathology results.ResultsRates of EE recurrence during the 24-wk maintenance period were 16.8%, 5.1%, and 2.0% with lansoprazole 15 mg, vonoprazan 10 mg, and vonoprazan 20 mg, respectively. Vonoprazan was shown to be non-inferior to lansoprazole 15 mg (P < 0.0001 for both doses). In a post-hoc analysis, EE recurrence at Week 24 was significantly reduced with vonoprazan at both the 10 mg and the 20 mg dose vs lansoprazole 15 mg (5.1% vs 16.8%, P = 0.0002, and 2.0% vs 16.8%, P < 0.0001, respectively); by contrast, the EE recurrence rate did not differ significantly between the two doses of vonoprazan (P = 0.1090). The safety profiles of vonoprazan 10 and 20 mg were similar to that of lansoprazole 15 mg in patients with healed EE. Treatment-related AEs were reported in 11.4%, 10.4%, and 10.3% of patients in the lansoprazole 15 mg, vonoprazan 10 mg, and vonoprazan 20 mg arms, respectively.ConclusionOur findings confirm the non-inferiority of vonoprazan 10 and 20 mg to lansoprazole 15 mg as maintenance therapy for patients with healed EE.

Project description:Background and study aims ?Non-erosive reflux disease (NERD) includes minimal change esophagitis (MCE) and no endoscopic abnormalities. However, for most endoscopists, it is difficult to detect MCE with conventional white-light endoscopy (WLE). Linked color imaging (LCI) technology is the most recently developed image-enhancing technology and improves detection and differentiation of subtle mucosal changes using a color contrast method. This study assessed the efficacy of WLE combined with LCI for diagnosing MCE compared with WLE. Patients and methods ?Between February and May 2017, 44 NERD patients and 40 healthy subjects were enrolled in our study. First, the distal esophagus was examined using WLE followed by LCI. Second, three experienced endoscopists observed all the patients' white-light (WL) images and corresponding images of WL and LCI and then recorded presence or absence of minimal change esophagitis (MCE?+/-). The proportion of minimal change between the two groups was then compared. Third, five blinded endoscopists with different levels of endoscopic experience assessed whether MCE was present. Intraobserver reproducibility and interobserver agreement were described using the kappa value. Results ?The proportion of MCE in the NERD group (70.8?%, 35/48) was higher than that in the control group (22.5?%, 9/40, P ?<?0.001) when diagnosed by the three experienced endoscopists. Detection rates for MCE using WLE combined with LCI were higher than those using WLE (43/88, 48.9?% vs. 29/88, 33.0?%, P ?<?0.001). With WLE combined with LCI, intraobserver reproducibility signi?cantly improved, indicating that the combined approach can improve interobserver agreement compared with using WLE alone. Conclusions ?Endoscopic diagnosis of MCE using WLE combined with LCI images is effective. Intraobserver reproducibility and interobserver agreement in MCE can be improved when LCI is applied with conventional imaging (Clinical trial registration number: NCT03068572).

Dataset Information

Dual Delayed-Release Dexlansoprazole for Healing and Maintenance of Healed Erosive Esophagitis: A Safety Study in Adolescents.

Publications

Dual Delayed-Release Dexlansoprazole for Healing and Maintenance of Healed Erosive Esophagitis: A Safety Study in Adolescents.

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