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.
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