Ambulatory Reflux Monitoring Guides Proton Pump Inhibitor Discontinuation in Patients With Gastroesophageal Reflux Symptoms: A Clinical Trial

• Authors: Rena Yadlapati, University of California San Diego; Melina Masihi, Northwestern University; Prakash C Gyawali, Washington University; Dustin A Carlson, Northwestern University; Peter J Kahrilas, Northwestern University; Billy D Nix, Washington University; Anand Jain, Emory University; Joseph R Triggs, University of Pennsylvania; Michael F Vaezi, Vanderbilt University; Leila Kia, Northwestern University; Alexander Kaizer, University of Colorado, Aurora; John E Pandolfino, Northwestern University
• Journal Title: GASTROENTEROLOGY
• Volume: Volume 160, Number 1
• Publisher: W B SAUNDERS CO-ELSEVIER INC | 2021-01-01, Pages 174-+
• Type of Work: Article | Post-print: After Peer Review
• Publisher DOI: http://doi.org/10.1053/j.gastro.2020.09.013
• Subjects: Health Sciences, Medicine and Surgery; Health Sciences, Nutrition; Biology, Biostatistics
• Keywords: Science & Technology; Life Sciences & Biomedicine; Gastroenterology & Hepatology; Gastroesophageal Reflux Disease (GERD); Wireless pH Monitoring; Bravo; Functional Heartburn; PPI NONRESPONDERS; MANAGEMENT; DIAGNOSIS; DISEASE; RECOMMENDATIONS; CLASSIFICATION; QUESTIONNAIRE; GUIDELINES; PHYSICIANS; DISORDERS

Abstract

Background and Aims: Proton pump inhibitor (PPI) therapy fails to provide adequate symptom control in up to 50% of patients with gastroesophageal reflux symptoms. Although a proportion do not require ongoing PPI therapy, a diagnostic approach to identify candidates appropriate for PPI cessation is not available. This study aimed to examine the clinical utility of prolonged wireless reflux monitoring to predict the ability to discontinue PPIs. Methods: This double-blinded clinical trial performed over 3 years at 2 centers enrolled adults with troublesome esophageal symptoms of heartburn, regurgitation, and/or chest pain and inadequate PPI response. Participants underwent prolonged wireless reflux monitoring (off PPIs for ≥7 days) and a 3-week PPI cessation intervention. Primary outcome was tolerance of PPI cessation (discontinued or resumed PPIs). Symptom burden was quantified using the Reflux Symptom Questionnaire electronic Diary (RESQ-eD). Results: Of 128 enrolled, 100 participants met inclusion criteria (mean age, 48.6 years; 41 men). Thirty-four participants (34%) discontinued PPIs. The strongest predictor of PPI discontinuation was number of days with acid exposure time (AET) > 4.0% (odds ratio, 1.82; P <.001). Participants with 0 days of AET > 4.0% had a 10 times increased odds of discontinuing PPI than participants with 4 days of AET > 4.0%. Reduction in symptom burden was greater among the discontinued versus resumed PPI group (RESQ-eD, –43.7% vs –5.3%; P =.04). Conclusions: Among patients with typical reflux symptoms, inadequate PPI response, and absence of severe esophagitis, acid exposure on reflux monitoring predicted the ability to discontinue PPIs without symptom escalation. Upfront reflux monitoring off acid suppression can limit unnecessary PPI use and guide personalized management. (ClinicalTrials.gov, Number: NCT03202537)