T1998 Evaluation of the Proton Pump Inhibitor (PPI) Test in GERD pts with and Without Erosive Esophagitis: Results from the Diamond Study

Abstract

Background: Previous studies have suggested that response to PPIs is inferior in pts with non-erosive reflux disease, possibly because a subset of these pts suffer from non-acid related symptoms. The aim of this study (AstraZeneca study code: D99142) was to determine the performance of a PPI test in pts with and without erosive esophagitis. Methods: Consecutive pts presenting to primary care practices with any upper gastrointestinal (GI) symptoms thought to be of upper GI tract origin, and having been off PPI for at least 2 months, underwent endoscopy and wireless esophageal pH monitoring (BravoTM). GERD was defined as any esophageal mucosal breaks, acid exposure >5.5% of time, symptom association probability ≥95%, or absence of reflux symptoms (heartburn, regurgitation, central chest pain and dysphagia) after esomeprazole treatment (only for pts with acid exposure 3.5-5.5% of time). Pts were blinded to the diagnosis until they left the study. Placebo was administered each morning, from the first encounter until completion of pH monitoring 1 week later, when it was switched to esomeprazole 40mg for 14 days. Pts were unaware of the switch time point. Pts were asked to record the two most bothersome symptoms daily in a paper diary. Placebo response was defined as absence of the most bothersome symptom for the last 2 days on placebo and PPI response as absence of the most bothersome symptom in the last 3 days. Results: 73 study sites in 6 countries provided 308 fully evaluable pts, 296 of whom had an evaluable PPI test. GERD was diagnosed in 197/296 pts (66%) according to the pre-defined criteria. PPI response in pts with esophagitis, in pts diagnosed with GERD without esophagitis and in pts without GERD is presented for all pts, for pts without a placebo response and for pts who did and did not report a reflux symptom as their most bothersome symptom in the table. Conclusions: In this study, response to the PPI test in GERD pts in primary care was slightly higher in those with erosive esophagitis than in those without. Response to PPI test