Long-term maintenance vonoprazan beneficial for PPI-resistant reflux oesophagitis

Treatment with the novel acid secretion inhibitor vonoprazan at 10 mg effectively maintains remission through 52 weeks in patients with proton pump inhibitor (PPI)-resistant reflux oesophagitis, according to the results of a trial from Japan.

Possessing potent and rapid acid secretion-suppressive properties, vonoprazan has been previously shown to induce endoscopic healing in the population at the 20-mg dose within 4 weeks and maintain remission for up to 8 weeks at the 10-mg dose. [Aliment Pharmacol Ther 2015;42:719-730; Aliment Pharmacol Ther 2016;43:240-251; Digestion 2017;95:156-161]

In the current analysis, researchers evaluated the long-term outcome of maintenance treatment in 16 patients with PPI-resistant reflux oesophagitis (mean age, 70.9 years; 50 percent male) who were on remission and continued receiving maintenance 10-mg vonoprazan until 52 weeks.

All but one patient (93.8 percent) remained on remission at week 52. The sole patient who relapsed was found with grade C disease. [Esophagus 2019;doi:16:377-381]

The fasting gastrin level before breakfast decreased from 917.5 pg/mL at week 8 to 687.5 pg/mL in 10 patients. This indicates that the gastrin level does not continuously increase with long-term maintenance therapy with 10-mg vonoprazan, according to the researchers.

There were no significant changes observed in the frequency scale for the symptoms of gastro-oesophageal reflux disease score and in mucosal properties, including the number and size of polyps, in the stomach on endoscopy.

“This is the first report of the long-term maintenance therapy of patients with reflux oesophagitis resistant to the standard dose of PPI in Japan treated with 10-mg vonoprazan for 52 weeks,” the researchers said.

“As mucosal break in reflux oesophagitis is associated with the excessive oesophageal acid exposure time, our results indicate that the oesophageal acid exposure time was sufficiently controlled by 10-mg vonoprazan administration,” they added.

The high rate of maintenance of endoscopic remission with the novel acid secretion inhibitor may also be attributed to its superior acid suppression effects when compared with those of standard-dose PPI, according to the authors.

Previous studies have shown that the percent time with a gastric pH of ≥4 on day 7 of standard-dose PPI administration was 50–60 percent, whereas that with 10-mg vonoprazan was 63 percent on average. [Aliment Pharmacol Ther 2015;41:636-648; Clin Pharmacol Ther 2006;79:144-152; Aliment Pharmacol Ther 2007;15:501-510; Clin Drug Investig 2004;24:1-7]