Vonoprazan non‐inferior to lansoprazole in treating duodenal ulcer and eradicating Helicobacter pylori in Asian patients

Abstract Background and Aim Duodenal ulcers, especially caused by increasingly drug‐resistant Helicobacter pylori , are a concern in Asia. We compared oral vonoprazan versus lansoprazole for efficacy (healing duodenal ulcers) and safety in non‐Japanese Asian patients. Methods In this phase 3, randomized (1:1), double‐blind, double‐dummy, parallel‐group, non‐inferiority study (April 5, 2017, to July 19, 2019), patients with ≥ 1 endoscopically confirmed duodenal ulcer, at 52 hospitals (China, South Korea, and Taiwan), received vonoprazan 20 mg once daily (QD) or lansoprazole 30 mg QD for 6 weeks maximum. Patients with H. pylori received bismuth‐containing quadruple therapy including vonoprazan 20 mg twice daily (BID) or lansoprazole 30 mg BID, for 2 weeks, followed by vonoprazan or lansoprazole monotherapy QD (4 weeks maximum). Endpoints were endoscopically confirmed duodenal ulcer healing (Week 4/6; primary) and H. pylori eradication (4 weeks post‐treatment; secondary); non‐inferiority margins were −6% and −10%, using a two‐sided 95% confidence interval (CI). Results Of 533 enrolled patients, one was lost to follow‐up and one withdrew (full analysis set: 531 patients [vonoprazan, n = 263; lansoprazole, n = 268]; 85.4% = H. pylori positive). Vonoprazan was non‐inferior to lansoprazole for duodenal ulcer healing (96.9% vs 96.5%; difference 0.4% [95% CI −3.00, 3.79]). H. pylori eradication rates were 91.5% (vonoprazan) and 86.8% (lansoprazole; difference 4.7% [95% CI −1.28, 10.69]). Vonoprazan and lansoprazole were well tolerated, with similar safety profiles, no new safety signals; no deaths occurred. Conclusions Vonoprazan was well tolerated and non‐inferior to lansoprazole for duodenal ulcer healing and achieved H. pylori eradication above the clinically meaningful threshold (90%), in non‐Japanese Asian patients.