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Summary   Background  Vonoprazan is a new potassium‐competitive acid blocker for treatment of acid‐related diseases.    Aim  To conduct two randomised‐controlled trials, to evaluate the non‐inferiority of vonoprazan vs. lansoprazole, a proton pump inhibitor, for treatment of gastric ulcer ( GU ) or duodenal ulcer ( DU ).    Methods  Patients aged ≥20 years with ≥1 endoscopically‐confirmed  GU  or  DU  (≥5 mm white coating) were randomised 1:1 using double‐dummy blinding to receive lansoprazole (30 mg) or vonoprazan (20 mg) for 8 ( GU  study) or 6 ( DU  study) weeks. The primary endpoint was the proportion of patients with endoscopically confirmed healed  GU  or  DU .    Results  For  GU , 93.5% (216/231) of vonoprazan‐treated patients and 93.8% (211/225) of lansoprazole‐treated patients achieved healed  GU ; non‐inferiority of vonoprazan to lansoprazole was confirmed [difference = −0.3% (95%  CI  −4.750, 4.208);  P  = 0.0011]. For  DU , 95.5% (170/178) of vonoprazan‐treated patients and 98.3% (177/180) of lansoprazole‐treated patients achieved healed  DU ; non‐inferiority to lansoprazole was not confirmed [difference = −2.8% (95%  CI  −6.400, 0.745);  P  = 0.0654]. The incidences of treatment‐emergent adverse events were slightly lower for  GU  and slightly higher for  DU  with vonoprazan than with lansoprazole. There was one death (subarachnoid haemorrhage) in the vonoprazan group ( DU ). The possibility of a relationship between this unexpected patient death and the study drug could not be ruled out. In both studies, increases in serum gastrin levels were greater in vonoprazan‐treated vs. lansoprazole‐treated patients; levels returned to baseline after treatment in both groups.    Conclusions  Vonoprazan 20 mg has a similar tolerability profile to lansoprazole 30 mg and is non‐inferior with respect to  GU  healing and has similar efficacy for  DU  healing.

alimentary pharmacology and therapeutics

Randomised clinical trial: efficacy and safety of vonoprazan vs. lansoprazole in patients with gastric or duodenal ulcers – results from two phase 3, non‐inferiority randomised controlled trials