Safety and efficacy of Vonoprazan-based triple therapy against Helicobacter pylori infection: A single-center experience with 1118 patients.

Abstract

Helicobacter pylori infection is the most common infectious disease worldwide and is thought to be a cause of gastric cancer [Park et al. 2014]. Standard therapy against H. pylori infection comprises coadministration of a proton-pump inhibitor with antibiotics; however, maintaining the pH of the stomach mucosa to preserve antibiotic function can be difficult. Vonoprazan, a novel potassiumcompetitive acid blocker, exerts rapid and strong proton-pump inhibition and has been approved in Japan for the treatment of acid-related disease and H. pylori infection [Garnock-Jones, 2015]. A few reports have described the non-inferiority of vonoprazan compared with lansoprazole in clinical trials, but published data regarding the efficacy and safety of vonoprazan against H. pylori infection, especially in the medical practice setting, are limited [Katayama et al. 2016; Ashida et al. 2016; Murakami et al. 2016]. From March 2015 to February 2016, 1118 patients with H. pylori infection (1172 cases) underwent treatment including vonoprazan at a single center in Nagasaki, Japan. This study was approved by the Yutaka Fukuda Surgery Clinic Institutional Review Board. H. pylori infection was determined by a urea breath test. Overall, 1021 patients received first-line 7-day therapy with vonoprazan, amoxicillin, and clarithromycin, a regimen approved for insurance coverage by the Japanese Government. A total of 151 patients, who had failed first-line therapy at our facility or another institution, were treated with vonoprazan, amoxicillin, and metronidazole as second-line therapy. The overall rate of grade 2 side effects, as defined by the Common Terminology Criteria for Adverse Events, was 2.1% and included diarrhea (0.98%), nausea or vomiting (0.36%), constipation (0.09%), abdominal pain (0.54%), skin rash (0.27%), and heartburn (0.45%). The rate of adverse effects was 2.0% for first-line therapy and 2.4% for secondline therapy. While confirmation of eradication was recommended to all participants, only 65% (724/1118) of patients chose to do so. Of the 669 patients who received first-line therapy and were retested for H. pylori infection after therapy, eradication was achieved in 614 cases (91.4%), which is comparable to the eradication rate reported by Murakami and colleagues for a smaller sample [Murakami et al. 2016]. Of 95 patients who received second-line therapy and were retested for H. pylori infection, eradication was achieved in all patients (100%). No significant difference in eradication rate was observed between age groups ( 74 years) or genders. Our data show that vonoprazan is an efficient and relatively well tolerated treatment for H. pylori infection.