Sa1233 EFFECT OF VONOPRAZAN ON PPI-RESISTANT REFLUX ESOPHAGITIS

Abstract

In 2015, Vonoprazan (VPZ), which exerts more potent and sustained acid-inhibitory effects than PPIs, became commercially available. In this study, we examined the efficacy of 4-week VPZ initial therapy at 20 mg for PPI-resistant RE, as well as that of 8-week and 52-week VPZ maintenance therapy at 10 mg in patients achieving healing. The subjects were 26 patients with PPI-resistant RE in whom esophageal mucosal breaks persisted despite administration of standard-dose PPIs for 8 weeks or more (13 males, 13 females, mean age: 70.0 years, LA classification grade A: 3 patients, B: 7, C: 13, and D: 3). All patients were negative for H. pylori infection (after eradication: 3 patients). In 25 patients, hiatal hernia measuring 2 cm or larger was detected (3 cm or larger: 19 patients). After confirming endoscopic healing by 4-week 20mg VPZ initial therapy, maintenance therapy with 10 mg VPZ was performed. Endoscopy was performed at 8 and 52 weeks after the initiation of maintenance therapy to evaluate whether there was any recurrence of RE. The study was discontinued for patients with recurrent RE at 8 weeks. Symptoms were assessed using the frequency scale for the symptoms of gastroesophageal reflux disease (F-scale) on days 1-7, 14, and 28 after the initiation of 20mg VPZ and at 8 and 52 weeks following the maintenance therapy with 10mg VPZ. Gastrin level was measured before breakfast at 8 and 52 weeks following the therapy. In 22 (84.6%) of the 26 patients, esophageal mucosal breaks were healed, whereas esophageal mucosal breaks of grade C persisted in 3 patients and grade A in one patient. The median F-score was significantly lower on days 1-7, 14, and 28 after the initiation of VPZ than before its administration. After 10mg VPZ maintenance therapy for 8 weeks, recurrence of RE was found in 4 patients (18.2%). These patients had LA grade C of RE. Eighteen patients (81.8%) maintained remission at 8 weeks continued on the maintenance therapy with 10mg VPZ until 52 weeks. While 2 patient had recurrent RE (grade B and C) at 52 weeks, the remaining 16 patients (88.9%) maintained remission. Overall remission maintenance rate of 10 mg VPZ at 52 weeks for PPI-resistant RE was 16 out of 22 patients (72.7%). There were no significant differences in the F-scale score at 8 and 52 weeks, nor the average gastrin score at 8 and 52 weeks (1055 and 832, respectively). 4-week initial therapy with 20mg VPZ was effective for patients with PPI-resistant RE. After an initial treatment for 4-week with 20mg VPZ, 52-week maintenance therapy with 10-mg vonoprazan is also effective for them especially in whom endoscopic healing was maintained by 8-week maintenance therapy with 10-mg VPZ. The efficacy of 20 mg VPZ initial therapy and 10 mg VPZ maintenance therapy for PPI-resistant RE patients were confirmed.