Esophagus to Small Intestine

Aliment Pharmacol Ther. 2022;55(12):1524–33

Chen S, Liu D, Chen H, Liao A, Li F, Liu C, Li X, Li S, Zhang Y, Wang Y, Xia M, Guo Q, Miao X, Wen Z, Xu M, Yin H, Chen H, Chen M, Xiao Y

The efficacy and safety of keverprazan, a novel potassium-competitive acid blocker, in treating erosive esophagitis: A phase 3, randomized, double-blind multicenter study

Background: Keverprazan is a novel potassium-competitive acid blocker (P-CAB) with a strong acid-suppressive capacity that may provide clinical benefit in acid-related diseases.
Aims: This study aimed to explore the non-inferior efficacy and safety of keverprazan to lansoprazole in treating erosive esophagitis (EE).
Methods: This was a phase 3, randomized, double-blind multicenter study. Patients were randomized to receive keverprazan 20 mg once daily or lansoprazole 30 mg once daily for 4–8 weeks. EE healing rates and adverse events (AEs) were compared between the keverprazan group and the lansoprazole group.
Results: A total of 238 patients comprised the full analysis set (FAS) while 221 patients comprised the per-protocol set (PPS). For FAS analysis, the EE healing rates at week 8 were 95.8% (114/119) and 89.9% (107/119) for keverprazan and lansoprazole respectively. For PPS analysis, the EE healing rates at week 8 were 99.1% (110/111) and 92.7% (102/110) for keverprazan and lansoprazole, respectively. Non-inferiority of keverprazan compared with lansoprazole according to EE healing rates at 8 weeks was demonstrated in both FAS (difference, 5.8%, 95% confidence interval [CI]: -0.6–12.3%; p = 0.081) and PPS (difference, 6.1%, 95% CI: 1.1–11.2%; p = 0.018) analysis. Drug-related AEs were reported in 34.5% (41/119) patients of the keverprazan group and 25.2% (30/119) patients of the lansoprazole group with no significant difference (p = 0.156). No severe AE happened in the keverprazan group.

Conclusions: This study demonstrated the non-inferior efficacy of keverprazan to lansoprazole in treating erosive esophagitis. The incidences of drug-related adverse events were comparable between keverprazan and lansoprazole.

Prof. Dr. Y. Xiao and Prof. Dr. M. Chen, Department of Gastroenterology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China,
E-Mail: xyingl@mail.sysu.edu.cn

and

E-Mail: chenminhu@mail.sysu.edu.cn

DOI: 10.1111/apt.16959

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