Comparing fexuprazan and rabeprazole for treating peptic ulcer: A multicenter, randomized controlled trial
Abstract
BACKGROUND
Fexuprazan, a novel potassium-competitive acid blocker, has several advantages over proton pump inhibitors and is used to treat various acid-related disorders.
AIM
To compare the efficacy and safety of fexuprazan and rabeprazole in treating patients with peptic ulcer disease (PUD) and confirm the non-inferiority of fexuprazan.
METHODS
This randomized, comparative, multicenter, open study was conducted in eight institutions in South Korea. The non-inferiority (margin of -10%) of fexuprazan 40 mg and rabeprazole 20 mg for 4 weeks or 8 weeks was analyzed in patients with PUD. The primary and secondary endpoints were the peptic ulcer healing rates after 8 weeks and 4 weeks, respectively. Symptom improvement and safety were assessed.
RESULTS
One hundred and seven patients with PUD were randomized, and 102 completed the study: 51 each in the fexuprazan and rabeprazole groups. Regarding the per protocol set, the healing rates after 8 weeks were 100% (51/51) and 98.04% (50/51) in the fexuprazan and rabeprazole groups, and the healing rates after 4 weeks were 98.04% (50/51) and 94.12% (48/51) in the fexuprazan and rabeprazole groups, respectively. For the full analysis set, the healing rates after 8 weeks were 98.08% (51/52) and 98.04% (50/51) in the fexuprazan and rabeprazole groups, and the healing rate after 4 weeks was 96.15% (50/52) and 94.12% (48/51) in the fexuprazan and rabeprazole groups, respectively. The 4-weeks and 8-weeks healing rates confirmed that the…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 8 participants or records.
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