Acid Reflux Monitoring May Indicate Candidates for PPI Discontinuation in Those With Typical Reflux Symptoms

reflux disease
reflux,gerd, acid reflux
Acid exposure measured via reflux monitoring can be predicative of a patient’s ability to discontinue PPI use without symptom escalation.

Among patients experiencing gastroesophageal reflux symptoms, inadequate symptom relief with proton pump inhibitor (PPI) therapy, the absence of severe esophagitis, and acid exposure measured via reflux monitoring was predictive of a patient’s ability to discontinue PPI use without symptom escalation, according to findings published in Gastroenterology.

Researchers conducted a double-blind, single-arm clinical trial (ClinicalTrials.gov identifier NCT03202537) in adults (N=128) with gastro-esophageal reflux symptoms who had inadequate response to PPI therapy recruited between 2017 and 2020. Patients who experienced 8 weeks of heartburn, regurgitation, or non-cardiac chest pain at least twice per week despite PPI therapy were eligible for enrollment.

Participants discontinued PPI therapy for 3 weeks and were assessed at 1 week via 96-hour wireless reflux monitoring. Participants then responded to the gastroesophageal reflux disease questionnaire (GerdQ) and the Reflux Symptom Questionnaire Electronic Diary (RESQ-eD) and were assessed for DeMeester scores.

Mean participant age was 48.6 plus or minus 14.9 years; 41% of participants were men, with a mean body mass index of 27.1 plus or minus 5.5 kg/m2, a mean GerdQ score of 8.6 plus or minus 4.2, a total acid exposure time of 5.8 plus or minus 3.8%, and a mean DeMeester score of 21.6 plus or minus 13.6.

Most participants (66%) resumed their PPI therapy. Compared with patients who discontinued PPI therapy, those who resumed had higher mean baseline GerdQ (9.3 vs 7.2; P =.01) and RESQ-eD (17.8 vs 12.0; P =.02) scores. During reflux monitoring, those who resumed PPI had higher acid exposure times (6.6% vs 4.3%; P <.01). For every day with an acid exposure time greater than 4%, there was a 1.8 increased odds for resuming PPI (odds ratio [OR], 1.82; 95% CI, 1.34-2.56; P <.01).

Patients who experienced 0 days with an acid exposure time greater than 4% were 10 times more likely to discontinue PPI compared with patients who experienced at least 4% acid exposure time each day (OR, 10.0; 95% CI, 2.70-43.32; P <.01).

At the study conclusion, the association of PPI cessation with gastroesophageal reflux disease (GERD) remained unclear. Although the investigators observed a trend for PPI resumption among patients with GERD, 14 patients without GERD resumed PPI, and 15 patients with GERD discontinued PPI. However, patients with GERD had a significantly greater reduction in RESQ-eD scores (-42.1% vs -7%; P =.03) compared with patients without GERD.

Study limitations include the lack of a placebo arm, which may introduce response bias among participants.

“This study is the first of its kind to provide high-level evidence in support of early reflux monitoring off acid suppression in order to phenotype the patient with inadequate PPI response, and [to] personalize care accordingly,” the researchers concluded. “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.”

Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.

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Reference

Yadlapati R, Masihi M, Gyawali P, et al. Ambulatory reflux monitoring guides proton pump inhibitor discontinuation in patients with gastroesophageal reflux symptoms: a clinical trial. Published online September 16, 2020. Gastroenterology. doi: 10.1053/j.gastro.2020.09.013