Pantoprazole 40 mg Is as Effective as Esomeprazole 40 mg To Relieve Symptoms of Gastroesophageal Reflux Disease (GERD) after 4 Weeks of Treatment and Superior Regarding Preventing of Symptomatic Relapse

Abstract

Purpose: Symptom relief assessed with the validated reflux questionnaire ReQuest™ and symptomatic relapse during a 7 days post-treatment phase was compared in patients with erosive GERD treated with pantoprazole 40 mg (PANTO) or esomeprazole 40 mg (ESO). Methods: In this randomized, double-blind, multicenter, parallel-group comparison conducted in Germany 561 patients (ITT) with endoscopically confirmed GERD grade A-D (LA Classification) received either PANTO (n = 284) 40 mg or ESO (n = 277) 40 mg once daily over a period of 4 weeks followed by a post-treatment period of 7 days without medication. For assessment of GERD-symptomatology, patients completed the ReQuest™ daily. Symptom relief was achieved if the score of the validated subscale ReQuest™-GI fell below a pre-defined GERD symptom threshold. The primary efficacy variable was the mean score of the ReQuest™-GI of the last 3 days of treatment. Non-inferiority of PANTO compared with ESO was tested by means of Hodges-Lehmann estimation, using a one-sided 97.5%-Confidence-Interval (CI) according to Moses. A non-inferiority margin of 1.725 (i.e. the pre-defined GERD symptom threshold) was assumed. In the post-treatment period, the maximum ReQuest™-GI sum score was determined and tested using the two-sided Median Two-Sample Test. For the same period, the rate of patients above the GERD symptom threshold was tested using the two-sided Fisher's Exact Test to characterize the clinically relevant symptomatic relapse. Results: The median ITT values (PP) of the mean scores of ReQuest™-GI during the last 3 days of active treatment were 0.24 (0.22) in the PANTO and 0.31 (0.30) in the ESO group (97.5% CI: −∞; + 0.010 (0.008)). Non-inferiority was concluded since the upper bound of the CI was below the non-inferiority margin. During the post-treatment phase the median values (PP) of the maximum ReQuest™-GI sum scores were 1.44 in the PANTO group and 2.18 in the ESO group (p = 0.0313). Furthermore, 46% in the PANTO and 54% in the ESO group showed a symptomatic relevant relapse in the post-treatment phase (p = 0.022). Conclusions: PANTO 40 mg is at least as effective as ESO 40 mg for symptom relief of GERD after 4 weeks of treatment. In the 7-day post-treatment phase without medication, patients in the PANTO group experienced significantly fewer symptomatic relapses.