Table 3.
Non-inferiority comparison of H. pylori eradication rates between the VD and VBQ groups.
| Analysis set | VBQ | VD | P-value for superiority | P-value for non-inferiority | Risk difference* |
|---|---|---|---|---|---|
| ITT | 83.4% (161/193) (95% CI: 78.2%, 88.7%) |
79.3% (153/193) (95% CI: 73.6%, 85.0%) |
0.296 | 0.070 | -4.15% (95% CI: -11.91%, 3.61%) |
| mITT | 90.4% (161/178) (95% CI: 86.1%, 94.8%) |
87.4% (153/175) (95% CI: 82.5%, 92.3%) |
0.365 | 0.018 | -3.02% (95% CI: -9.56%, 3.52%) |
| PP | 90.1% (155/172) (95% CI: 85.7%, 94.6%) |
87.7% (150/171) (95% CI: 82.8%, 92.6%) |
0.479 | 0.012 | -2.40% (95% CI: -9.04%, 4.24%) |
*Risk difference calculated as VD group minus VBQ group. The prespecified non-inferiority margin was -10%. Non-inferiority is concluded if the lower limit of the 95% confidence interval for the risk difference is above -10%.
H. pylori, Helicobacter pylori; VBQ, vonoprazan-bismuth-amoxicillin-doxycycline quadruple therapy; VD, vonoprazan-doxycycline dual therapy; ITT, intention-to-treat; mITT, modified intention-to-treat; PP, per-protocol.