S1351 A Study for Every Second Day Administration of Vonoprazan in Maintenance Treatment of Erosive GERD (ESD Von GERD): A Multicenter Randomized Crossover Study

Abstract

INTRODUCTION: Vonoprazan, a potassium competitive acid blocker, with stronger and more stable acid-suppressing effects than proton pump inhibitors (PPIs), is used to treat erosive gastroesophageal reflux disease (GERD). We clarified the usefulness and superiority of vonoprazan administered every second day over PPIs in maintenance therapy of erosive GERD. METHODS: This was a prospective, multicenter, open-label, two-period randomized crossover study. Patients were randomized to the PCPP group, which was administered vonoprazan 10 mg daily (q.d.) for the first 4 weeks and then lansoprazole 15 mg q.d. the next 4 weeks both administered every second day, and the PPPC group, which was treated in reverse. GERD symptoms including heartburn and acid reflux were compared between vonoprazan and lansoprazole using symptom diaries, frequency scale for symptoms of GERD (FSSG) and gastrointestinal symptom rating scale (GSRS). RESULTS: We enrolled 122 patients between December 2017 and May 2019. Asymptomatic proportion in vonoprazan administration and lansoprazole administration were 93.6% (105/112) and 82.1% (92/112), respectively, and it had a significant difference with analysis using McNemar’s test (P = 0.003). During the first 4 weeks, 93.3% and 85.7% patients were asymptomatic following treatment for ≥6 consecutive days a week in the PCPP and PPPC groups, respectively (P = 0.228), whereas during the second 4 weeks, 94.4% and76.7% patients, respectively were asymptomatic (P = 0.009). Furthermore, 96.7% and 80.0% of patients were asymptomatic with less than once weekly in the PCPP and PPPC groups, respectively, during the first 4 weeks (P = 0.007). GERD symptoms were significantly decreased with vonoprazan administered every second day using FSSG and GERD. CONCLUSION: vonoprazan every second day administration may reduce patient symptoms more effectively than PPIs in erosive GERD maintenance. Furthermore, vonoprazan could be effective maintenance therapies because of their inhibitory effects on gastric acid secretion even when administered every second day and could be selected on-demand. However, further research on long-term administration effects would be necessary.