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• W3096188973 abstract "See “Ambulatory reflux monitoring guides proton pump inhibitor discontinuation in patients with gastroesophageal reflux symptoms: a clinical trial,” by Yadlapati R, Masihi M, Gyawali CP, et al, on page 174. See “Ambulatory reflux monitoring guides proton pump inhibitor discontinuation in patients with gastroesophageal reflux symptoms: a clinical trial,” by Yadlapati R, Masihi M, Gyawali CP, et al, on page 174. Proton pump inhibitors (PPIs) have been the mainstay of medical therapy for gastroesophageal reflux disease (GERD) since their introduction in the late 1980s. Superior symptom relief compared to H2 receptor antagonists and an exceptional short-term safety profile propelled the class to unprecedented use, despite early concerns about side effects from acid suppression. The last decade, however, has highlighted multiple potentially serious adverse events1Schnoll-Sussman F. Niec R. Katz P.O. Proton pump inhibitors: the good, bad, and ugly.Gastrointestinal Endosc Clin North Am. 2020; 30: 239-251Abstract Full Text Full Text PDF PubMed Scopus (15) Google Scholar that, combined with concerns for over and misuse,2American Gastroenterological Association FoundationTreating GERD. Choosing wisely, volume 2020.2012Google Scholar have resulted in a shift in practice. Many patients and clinicians3Kurlander J.E. Kennedy J.K. Rubenstein J.H. et al.Patients' perceptions of proton pump inhibitor risks and attempts at discontinuation: a national survey.Am J Gastroenterol. 2019; 114: 244-249Crossref PubMed Scopus (34) Google Scholar,4Ghosh G. Schnoll-Sussman F. Matthews S. et al.Reported proton pump inhibitor side effects: what are physician and patient perspectives and behavior patterns.Aliment Pharmacol Ther. 2020; 51: 121-128Crossref PubMed Scopus (13) Google Scholar actively seek to decrease or discontinue the drugs early in the course of disease management. Unfortunately, strategies for doing this are rarely based on objective data and differ widely even among experts. Some favor weaning, others abruptly discontinuing. The successful step-down approach described by Inadomi et al5Inadomi J. Jamal R. Murata G. et al.Step down management of gastroesophageal reflux disease.Gastroenterology. 2001; 121: 1095-1100Abstract Full Text Full Text PDF PubMed Scopus (168) Google Scholar 20 years ago rarely is written about or followed. Patients with an incomplete or lack of response are not systematically studied and have PPIs discontinued in the blind, so to speak. This empiric approach precludes the clinician having confidence in the success of weaning or discontinuing PPIs, causing needless symptom relapse (confused with rebound), excessive visits, phone calls, and anxiety for patients. Many of these patients do not have GERD. Empiric management of long-term PPIs must stop. A clear strategy for diagnosis and managing PPI dosing, as reported in the excellent article by Yadlapati et al6Yadlapati R. Masihi M. Gyawali C.P. et al.Ambulatory reflux monitoring guides proton pump inhibitor discontinuation in patients with gastroesophageal reflux symptoms: a clinical trial.Gastroenterology. 2021; 160 (174–182)Google Scholar in this issue of Gastroenterology, is urgently needed if we are to be successful in effectively limiting PPI overuse. In this double-blind prospective 2-center study the authors performed 96-hour telemetry capsule pH monitoring (Bravo; Medtronic, Minneapolis, MN) in 100 consecutive patients with heartburn, regurgitation and/or chest pain with incomplete symptom relief after a documented once daily PPI trial. PPIs were stopped for 7 days before the study and for 2 additional weeks (3 total). Participants completed the Reflux Symptom Questionnaire electronic Diary,7Vakil N. Bjorck K. Denison H. et al.Validation of the reflux symptom questionnaire: electronic diary in partial responders to proton pump inhibitor therapy.Clin Transl Gastroenterol. 2012; 3: e7Crossref PubMed Scopus (16) Google Scholar on PPI at enrollment and off PPI at weeks 1–3. Patients with Los Angeles C or D erosive esophagitis, long segment Barrett’s esophagus, prior foregut surgery, major motility disorder, or >15 eosinophils per high power field on biopsy were excluded. The primary outcome was status of PPI use either discontinued or resumed PPI. Secondary outcomes included symptom change in the Reflux Symptom Questionnaire electronic Diary score and objective GERD on reflux monitoring. The sample size was calculated a priori. The results are robust, highlighted with data-rich tables and figures. The ability to discontinue PPIs was strongly associated with the number of days telemetry capsule was abnormal. A total esophageal acid exposure time (AET) of >4% provided the highest area under the curve, and thus was the upper limit of normal for this report. This differs from the value of an AET of >6% in the Lyon consensus8Gyawali C.P. Kahrilas P.J. Savarino E. et al.Modern diagnosis of GERD: the Lyon Consensus.Gut. 2018; 67: 1351-1362Crossref PubMed Scopus (584) Google Scholar (co-authored by several on this work). Patients with >2 days abnormal resumed PPIs close to 80% of the time. Patients normal all 4 days resumed PPIs 34% of the time. Four days normal AET increased the odds of discontinuing PPIs 10-fold compared with >2 days. Overall telemetry capsule results correctly predicted the primary outcome in 71 of 100 patients (71%). A clinically important minority of subjects had normal pH studies. More important, 66% had abnormal AET or DeMeester score (had GERD), despite incomplete symptom relief, reinforcing the need to study, because this group will be unlikely to tolerate being off therapy. Thirteen of 14 patients (93%) with grade B erosions had abnormal AET (had GERD), also inconsistent with the Lyon consensus. Symptom association scores were not useful in predicting outcome. Correlation of DeMeester scores, upright and supine AET, and the ability to remain off PPIs would be of interest, but were not reported. Patients with GERD had a small increase in RESQ-end scores at week 1 (rebound?); however, all patients who were able to stay off PPIs had a substantial decrease in scores at weeks 2 and 3. Patients with GERD who resumed PPI remained slightly above baseline at weeks 2 and 3 but decrease compared with week 1. These results suggest strongly that rebound, if it occurs at all, is rare, short lived, and is not present without GERD. This important physiologic observation should have little role in management decisions. Twelve patients had >15 eosinophils per high power field, a surprising finding in the absence of dysphagia. Further study of this finding in patients with incomplete symptom relief on PPIs is needed. Seven patients had incomplete capsule studies (<3 days recorded). Four days of recording is not universal. The study was only 3 weeks, likely too short. Longer studies are clearly needed to determine optimal strategies for discontinuing PPIs. These data cannot be extrapolated to patients with predominantly or exclusively extraesophageal presentations, a group less likely to have GERD and substantially more complex. The results are robust, but areas under the curve of 70% are not sufficient to guarantee outcome certainty. Several take-home points from this well-designed study are worthy of emphasis. First, a substantial majority of patients with symptoms suspected owing to GERD incompletely responsive to PPIs HAVE GERD and will need long term therapy. Second, a clear understanding of endoscopic and surgical interventions for GERD is mandatory for gastroenterologists managing these patients, because patients will ask about stopping PPIs and will require guidance on treatment alternatives. Third, additional data-based strategies are required for management of patients who DO NOT have GERD so PPIs can be effectively stopped. Finally, telemetry capsule pH monitoring is mandatory in patients with suspected GERD with an incomplete response to PPIs who have a normal endoscopy. Calibration-free capsules are now available, making placement at the time of endoscopy efficient, adding <2 minutes to the procedure. Patients with incomplete response to PPIs need an endoscopy off PPI and a 96-hour telemetry capsule if endoscopy is normal. If we “assess but don’t guess,” our patients will benefit. Ambulatory Reflux Monitoring Guides Proton Pump Inhibitor Discontinuation in Patients With Gastroesophageal Reflux Symptoms: A Clinical TrialGastroenterologyVol. 160Issue 1PreviewProton 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. Full-Text PDF" @default.
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• W3096188973 title "The Proton Pump Inhibitor Is Not Working: Assess Don’t Guess" @default.
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