BACKGROUND/AIM: Little is known about the symptom course during and after treatment of gastroesophageal reflux disease (GERD). Here we address this question in patients with erosive GERD treated withpantoprazole or esomeprazole 40 mg once daily using the validated reflux questionnaire ReQuest. METHODS: Of 585 patients enrolled, 561 (intention-to-treat; ITT) patients with endoscopically confirmed GERD grades A-D (Los Angeles Classification) were randomized. To assess the GERD symptomatology, the patients completed the ReQuest daily, and analysis was done prior to (7 days), during (28 days), and after treatment (7 days). The mean scores (last 3 treatment days) of the subscale ReQuest(TM)-GI (gastrointestinal complaints) were compared between both groups. After the end of treatment, the number of symptom episodes and the rate of relapses were calculated. RESULTS: Noninferiority of pantoprazole versus esomeprazole during treatment was shown (mean ReQuest-GI score). During the posttreatment period, the proportion of patients experiencing a symptomatic relapse (51 vs. 61%, p = 0.0216, ITT) and the number of symptom episodes (0.56 vs. 0.74, p = 0.0095, ITT) were significantly lower on pantoprazole than on esomeprazole. CONCLUSIONS:Pantoprazole 40 mg was at least as effective as esomeprazole 40 mg for relieving GERD symptoms. During the posttreatment phase, patients on pantoprazole had a significantly lower risk to relapse and experienced significantly fewer symptom episodes. Copyright 2007 S. Karger AG, Basel.
RCT Entities:
BACKGROUND/AIM: Little is known about the symptom course during and after treatment of gastroesophageal reflux disease (GERD). Here we address this question in patients with erosive GERD treated with pantoprazole or esomeprazole 40 mg once daily using the validated reflux questionnaire ReQuest. METHODS: Of 585 patients enrolled, 561 (intention-to-treat; ITT) patients with endoscopically confirmed GERD grades A-D (Los Angeles Classification) were randomized. To assess the GERD symptomatology, the patients completed the ReQuest daily, and analysis was done prior to (7 days), during (28 days), and after treatment (7 days). The mean scores (last 3 treatment days) of the subscale ReQuest(TM)-GI (gastrointestinal complaints) were compared between both groups. After the end of treatment, the number of symptom episodes and the rate of relapses were calculated. RESULTS: Noninferiority of pantoprazole versus esomeprazole during treatment was shown (mean ReQuest-GI score). During the posttreatment period, the proportion of patients experiencing a symptomatic relapse (51 vs. 61%, p = 0.0216, ITT) and the number of symptom episodes (0.56 vs. 0.74, p = 0.0095, ITT) were significantly lower on pantoprazole than on esomeprazole. CONCLUSIONS:Pantoprazole 40 mg was at least as effective as esomeprazole 40 mg for relieving GERD symptoms. During the posttreatment phase, patients on pantoprazole had a significantly lower risk to relapse and experienced significantly fewer symptom episodes. Copyright 2007 S. Karger AG, Basel.
Authors: Kate McKeage; Stephanie K A Blick; Jamie D Croxtall; Katherine A Lyseng-Williamson; Gillian M Keating Journal: Drugs Date: 2008 Impact factor: 9.546