Preference for On-Demand Fexuprazan Therapy in Gastroesophageal Reflux Disease: A Prospective Cohort Study

Abstract

Introduction: Maintenance therapy is crucial in managing and preventing symptom relapse in gastroesophageal reflux disease (GERD), with continuous and on-demand therapy being the common approaches. However, maintenance therapy using potassium-competitive acid blockers (P-CABs), such as fexuprazan, remains incompletely evaluated. Methods: This single-center, single-arm, prospective cohort study enrolled individuals with weekly heartburn or acid regurgitation and confirmed erosive esophagitis. The participants received 40 mg fexuprazan daily for 4 weeks as initial therapy, followed by 4 weeks of maintenance therapy. Patients chose either continuous or on-demand therapy for maintenance, according to their preference. The primary endpoint was the proportion of patients selecting on-demand therapy. The symptom scores were assessed using the GERD questionnaire (GERD-Q) and patient assessment of upper-gastrointestinal-disorders symptoms questionnaire (PAGI-SYM). Results: The 31 included participants showed a significant reduction in symptom scores after initial treatment (baseline vs. 4-week: GERD-Q, 9.0 vs. 6.5, p < 0.001; PAGI-SYM, 29.0 vs. 10.8, p < 0.001). Twenty-one (67.7%) patients chose on-demand therapy after initial treatment. The symptom scores did not differ significantly before and after maintenance therapy (4-week vs. 8-week: GERD-Q, 6.5 vs. 6.0, p = 0.225; PAGI-SYM, 10.8 vs. 9.0, p = 0.354). Although this relation was not significant, patients experiencing larger decreases in symptom scores tended to prefer on-demand therapy. After maintenance therapy, the symptom scores did not differ between continuous and on-demand therapy (GERD-Q, 5.3 vs. 6.3, p = 0.342; PAGI-SYM, 9.4 vs. 8.8, p = 0.611). Conclusions: Fexuprazan was effective as an initial and maintenance therapy in patients with GERD who showed typical symptoms. Approximately 68% of the patients preferred on-demand therapy as a maintenance treatment. Based on the patient's preference for maintenance therapy, symptom control did not differ between continuous and on-demand therapy.

Keywords: fexuprazan; gastroesophageal reflux disease; maintenance therapy.

Figure 1

Study flow diagram. On-demand therapy was defined as consuming <80% of prescribed medication. GERD-Q, gastroesophageal reflux disease questionnaire; PAGI-SYM, patient assessment of upper-gastrointestinal-disorders symptoms questionnaire.

Figure 2

Changes in GERD-Q and PAGI-SYM scores. Each dot represents a study participant, with orange indicating the baseline, cyan representing the 4-week point, and purple denoting the 8-week point. GERD-Q, gastroesophageal reflux disease questionnaire; PAGI-SYM, patient assessment of upper-gastrointestinal-disorders symptoms questionnaire.

Figure 3

Medication adherence rate during maintenance therapy. Continuous and on-demand therapies were allowed during maintenance therapy. On-demand therapy was defined as consuming <80% of prescribed medication. Each dot represents a study participant, with orange indicating those who received continuous therapy and cyan representing those who received on-demand therapy.

Figure 4

Changes in heartburn and regurgitation frequency scores of GERD-Q. Left panel (A) is color-coded based on baseline scores (range: 0–6); right panel (B) is color-coded based on preference for maintenance therapy. In the left panel, the different colors represent the GERD-Q scores at the baseline. In the right panel, orange represents continuous therapy and green represents on-demand therapy. Y-axis indicates heartburn and regurgitation frequency scores. GERD-Q, gastroesophageal reflux disease questionnaire.