Acid exposure reflux monitoring predicts PPI discontinuation in GERD
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Acid exposure reflux monitoring predicted the ability to discontinue proton pump inhibitor use without symptom escalation among patients with gastroesophageal reflux disease and inadequate proton pump inhibitor response.
“This study is the first of its kind to provide high-level evidence in support of early reflux monitoring of acid suppression in order to phenotype the patient with inadequate PPI response, and personalize care accordingly,” Rena Yadlapati, MD, MS, from the division of gastroenterology at the University of California, San Diego School of Medicine and colleagues wrote. “A phenotype guided care approach for patients with suspected GERD and inadequate PPI response has tremendous implications for health-related quality of life and resource utilization associated with GERD.”
Yadlapati and colleagues enrolled 128 patients with heartburn, regurgitation, chest pain and inadequate PPI response into a double-blind clinical trial over 3 years at two centers. One hundred patients met inclusion criteria and remained in the study. Patients underwent prolonged wireless reflux monitoring (off PPI for over 7 days) followed by a 3-week PPI cessation intervention. Tolerance of PPI cessation — discontinued or resumed PPI — served as the primary outcome. Investigators used the Reflux Symptom Questionnaire electronic diary to quantify symptom burden.
Thirty-four patients continued PPIs. The number of days with acid exposure time over 4% (OR = 1.82; P < .001) was the strongest predictor for PPI discontinuation. Investigators reported that patients with 0 days of acid exposure time over 4% had a 10 times increased chance for discontinuation of PPI compared with patients with 4 days of acid exposure time over 4%.
According to researchers, reduction in symptom burden was greater in the discontinued PPI group compared with the resumed PPI group (RESQ-eD –43.7% vs. –5.3%; P = .04).
“Upfront reflux monitoring off acid suppression can limit unnecessary PPI use and guide personalized management,” the researchers wrote.
Perspective
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This article presents results from a single arm, double-blind clinical trial on the utility of ambulatory reflux monitoring for personalized guidance of proton-pump inhibitor (PPI) therapy. This is an important topic because PPIs are some of the most commonly prescribed medications in the US, and prolonged, unnecessary PPI use results in significant burden to the patient and to healthcare in general.
The study was done in patients with typical GERD symptoms who failed single-dose PPI for 8 weeks. It was found that 96-hour ambulatory pH monitoring via Bravo off-therapy, predicted tolerance of PPI cessation. Specifically, patients with 0 days of abnormal acid exposure time (AET) greater than 4%, had a 10-fold increase in odds of being able to stay off PPI, compared to those with AET greater than 4% across all 4 days. A third of all patients in this study were able to tolerate cessation of PPI, and two-thirds in those with 0 days of abnormal acid exposure. From these results, we have the much-needed evidence to reassure patients with negative pH monitoring to stop PPI, and to try alternative therapies. This translates to significant cost-saving in patients with inadequate PPI response.
It is important to note that among the 34 patients that were able to stay off PPI, 15 of them had objective GERD with AET greater than 4 for more than 2 days, seven of whom actually had erosive esophagitis on EGD. This highlights the limitations of patient reported symptoms in guiding PPI therapy, since this group of patients would benefit from continued or even escalated PPI use.
This study demonstrates that, in the era of ambulatory pH monitoring, we no longer have to rely on patient reported symptoms, but rather, we can personalize PPI therapy based on objective measurements of GERD. It should be kept in mind that patients with extraesophageal symptoms only were excluded in this study, and I would be curious to see the trial done in that population.
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