PGI8: RAPID IMPACT OF RABEPRAZOLE ON SYMPTOM DISTRESS AMONG PATIENTS WITH GASTROESOPHAGEAL REFLUX DISEASE

Abstract

OBJECTIVES: Gastroesophageal reflux disease (GERD) is a common condition associated with a variety of symptoms, particularly heartburn. The purpose of this study was to assess patient-reported symptom distress in a randomized trial of rabeprazole (RAB), a proton pump inhibitor. METHODS: Symptom distress was measured using the Distress subscale of the GERD Symptom Assessment Scale (GSAS) that asks patients about the degree of bother they experience for 15 symptoms. Patients completed the GSAS at baseline and week 4. We evaluated the impact of treatment (RAB 10mg, RAB 20mg, or placebo) on mean change in GSAS Distress scores using an ANCOVA model. We also conducted a relative variability analysis using ANOVA models to determine which of 5 clinical indicators are most useful to explain changes in GSAS Distress scores. Mean change was assessed as a function of baseline daytime heartburn severity, baseline nighttime heartburn severity, time to first 24 hours without heartburn symptoms, complete daytime heartburn relief, and complete nighttime heartburn relief. RESULTS: The sample consisted of 169 patients (RAB10mg = 55, RAB 20mg = 56, placebo = 58). Overall, a significant difference in mean change in GSAS Distress scores was observed across treatment groups (p = 0.0007). Both the RAB 10mg and RAB 20mg groups reported significantly greater improvements in GSAS Distress scores than the placebo group (p = 0.0036 and p = 0.0004, respectively). Of the 5 clinical indicators examined, time to first 24 hours without heartburn explained the greatest amount of variability in GSAS Distress scores. Achieving complete daytime and complete nighttime heartburn relief also were significant factors. CONCLUSIONS: In clinical studies, RAB provided fast and consistent (both daytime and nighttime) heartburn relief. Given that speed of heartburn relief as well as achieving complete heartburn relief were significant factors explaining variability in patient-reported symptom distress, the positive impact of RAB on the GSAS distress scale was consistent with its clinical efficacy.