Safety and effectiveness of Fexuprazan for gastritis management

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Created On: 19/07/2023

A phase III randomized clinical trial examined the safety and effectiveness of Fexuprazan (a novel potassium-competitive acid blocker [P-CAB]) in treating individuals with acute or chronic gastritis.

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Key take away

In patients diagnosed with acute or chronic gastritis, both Fexuprazan 20 mg once daily and 10 mg twice daily for 2 weeks can effectively improve gastric erosions.

Background

A phase III randomized clinical trial examined the safety and effectiveness of Fexuprazan (a novel potassium-competitive acid blocker [P-CAB]) in treating individuals with acute or chronic gastritis.

Method

Overall, 20 mg of Fexuprazan once a day (q.d.), Fexuprazan 10 mg two times a day (b.i.d.), or placebo was administered to 327 subjects with chronic or acute gastritis who had >1 stomach erosions on endoscopy and subjective symptoms for two weeks. The major outcome (improvement in erosion rate), secondary outcomes (cure rates for erosion and edema and improvement rates for hemorrhage, redness, and subjective symptoms), and drug-related adverse events were also assessed post-treatment.

Result

After receiving 20 mg Fexuprazan q.d., 10 mg Fexuprazan b.i.d., and placebo, the patients' erosions improved 2 weeks later, as shown in Figure 1:

Fexuprazan 20 mg q.d. and 10 mg b.i.d. both outperformed the placebo in terms of effectiveness. The erosion healing rates for Fexuprazan 20 mg q.d. and 10 mg b.i.d. were likewise greater than the placebo. Between the Fexuprazan and placebo groups, there was no discernible difference in the rates of edema healing, subjective symptoms, hemorrhage, and improvement in redness. No profound difference was noted in the occurrence of adverse drug reactions.

Conclusion

For the management of acute or chronic gastritis, Fexuprazan had statistically better effectiveness than placebo. This novel potassium-competitive acid blocker appears to be a potential alternative to treat gastritis owing to its promising effectiveness and safety profile.