摘要
AIM To compare symptom control with esomeprazoleregimens for non-erosive reflux disease and chronicgastritis in patients with a negative endoscopy.METHODS: This randomized, open-label study wasdesigned in line with clinical practice in China. Patientswith typical reflux symptoms for ≥ 3 mo and a negativeendoscopy who had a Gastroesophageal Reflux DiseaseQuestionnaire score ≥ 8 were randomized to initialtreatment with esomeprazole 20 mg once daily eitherfor 8 wk or for 2 wk. Patients with symptom reliefcould enter another 24 wk of maintenance/on-demandtreatment, where further courses of esomeprazole 20mg once daily were given if symptoms recurred. Theprimary endpoint was the symptom control rate at week24 of the maintenance/on-demand treatment period.Secondary endpoints were symptom relief rate, successrate (defined as patients who had symptom reliefafter initial treatment and after 24 wk of maintenancetreatment), time-to-first-relapse and satisfaction rate.RESULTS: Based on the data collected in the modifiedintention-to-treat population (MITT; patients in the ITTpopulation with symptom relief after initial esomeprazoletreatment, n = 262), the symptom control rate showeda small but statistically significant difference in favorof the 8-wk regimen (94.9% vs 87.3%, P = 0.0473).Among the secondary endpoints, based on the datacollected in the ITT population (n = 305), the 8-wkgroup presented marginally better results in symptomrelief after initial esomeprazole treatment (88.3% vs83.4%, P = 0.2513) and success rate over the wholestudy (83.8% vs 72.8%, P = 0.0258). The 8-wkregimen was found to provide a 46% reduction in riskof relapse vs the 2-wk regimen (HR = 0.543; 95%CI:0.388-0.761). In addition, fewer unscheduled visits andhigher patient satisfaction supported the therapeuticbenefits of the 8-wk regimen over the 2-wk regimen.Safety was comparable between the two groups, withboth regimens being well tolerated.CONCLUSION: Chinese patients diagnosed withchronic gastritis achieved marginally better control ofreflux symptoms with an 8-wk vs a 2-wk esomeprazoleregimen, with a similar safety profile.
基金
Supported by Grant from AstraZeneca