Four days is an optimal time for wireless reflux monitoring to determine which patients can stop taking proton pump inhibitors (PPIs) and which ones need long-term antireflux therapy, researchers report.
“This first-of-its kind double-blinded clinical trial demonstrates the comparable, and in some cases better, performance of a simple assessment of daily acid exposure from multiple days of recording compared to other composite or complex assessments,” write Rena Yadlapati, MD, with the Division of Gastroenterology at the University of California, San Diego, and her coauthors.
Their findings were published online in the American Journal of Gastroenterology.
A substantial percentage of patients who have esophageal reflux symptoms do not have gastroesophageal reflux disease (GERD) and can stop taking PPIs.
Wireless reflux monitoring performed while patients are not taking PPIs is the gold standard for determining whether a patient has abnormal acid from GERD, but the optimal daily acid exposure time (AET) and the optimal duration of monitoring have not been well studied.
Aiming to fill this knowledge gap, Dr. Yadlapati and her colleagues conducted a single-arm, double-blinded clinical trial over 4 years at two tertiary care centers. They enrolled adult patients who had demonstrated an inadequate response to more than 8 weeks’ treatment with PPIs.
Study participants were asked to stop taking their PPI for 3 weeks in order for the investigators to determine the rate of relapse after PPI use and establish the study reference standard to discontinue therapy. During the 3-week period, after having stopped taking PPIs for at least a week, patients underwent 96-hour wireless reflux monitoring. They were then told to continue not taking PPIs for an additional 2 weeks. They could use over-the-counter antacids for symptom relief.
The primary outcome was whether PPIs could be successfully discontinued or restarted within 3 weeks. Of the 132 patients, 30% were able to stop taking PPIs.
AET less than 4.0% best discontinuation predictor
The team came to two key conclusions.
They found that acid exposure time of less than 4.0% was the best predictor of when stopping PPIs will be effective without worsening symptoms (odds ratio, 2.9; 95% confidence interval, 1.4-6.4). Comparatively, 45% (22 of 49 patients) with total AET of 4.0% or less discontinued taking PPIs, versus 22% (18 of 83 patients) with total AET of more than 4.0%.
Additionally, the investigators concluded that 96 hours of monitoring was better than 48 hours or fewer in predicting whether patients could stop taking PPIs (area under curve [AUC] for 96 hours, 0.63, versus AUC for 48 hours, 0.57).
Dr. Yadlapati told this news organization that the findings should be practice-changing.
“You really need to test for 4 days,” she said. She noted that the battery life of the monitor is 96 hours, and clinicians commonly only test for 2 days.
With only 1-2 days of monitoring, there is too much variability in how much acid is in the esophagus from one day to another. Monitoring over a 4-day period gives a clearer picture of acid exposure burden, she said.
Her advice: “If you have a patient with heartburn or chest pain and you think it might be from reflux, and they’re not responding to a trial of PPI, get the reflux monitoring. Don’t wait.”
After 4 days of monitoring, if exposure to acid is low, “they should really be taken off their PPI therapy,” she said.
They likely have a condition that requires a different therapy, she added.
“It is very consistent with what we have thought to be the case and what some lower-quality studies have shown,” she said. “It just hadn’t been done in a clinical trial with a large patient population and with a full outcome.”
