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For duodenal ulcer healing, 20 mg Keverprazan is non-inferior to once-daily dose of 30 mg Lansoprazole.
In a multicenter, double-blind, randomized phase III trial, Keverprazan 20 mg displayed a favorable safety profile and non-inferiority when compared to a once-daily dose of Lansoprazole 30 mg in terms of promoting the healing of duodenal ulcers. Tan ND et al. aimed to determine whether Keverprazan is non-inferior to Lansoprazole to relieve duodenal ulcer. A total of 360 volunteers diagnosed with active duodenal ulcer were randomly assigned in a 1:1 ratio to receive either Keverprazan (20 mg) or Lansoprazole (30 mg) treatment for 6 weeks.
The major outcome of the study was to evaluate the duodenal ulcer healing rate at week 6, while the secondary outcomes included assessing the safety of the treatments, improvement in symptoms, and duodenal ulcer healing rate at week 4. According to the analysis of the full set of data, the cumulative healing rates at week 6 were found to be 94.4% (170 out of 180) for Keverprazan and 93.3% (166 out of 178) for Lansoprazole, resulting in a small difference of 1.2%.
Similarly, at week 4, the respective healing rates were 83.9% (151 out of 180) for Keverprazan and 80.3% (143 out of 178) for Lansoprazole. In the per-protocol set analysis, the six-week healing rates for Keverprazan and Lansoprazole groups were 98.2% (163 out of 166) and 97.6% (163 out of 167) respectively, with a difference of 0.6%. On the other hand, the four-week healing rates were 86.8% (144 out of 166) and 85.6% (143 out of 167) for Keverprazan and Lansoprazole respectively.
These results indicated that Keverprazan was non-inferior to Lansoprazole in promoting duodenal ulcer healing after both 4 and 6 weeks of treatment. Additionally, the incidence of treatment-emergent adverse events was comparable between the two groups. Hence, Keverprazan's non-inferiority to Lansoprazole in terms of healing rates offers a promising alternative for acid-related disorders requiring potent acid inhibition.
Clinical and Translational Gastroenterology
Efficacy and safety of Keverprazan compared to Lansoprazole in the treatment of duodenal ulcer: a phase III, randomised, double-blind, multicentre trial
Tan ND et al.
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