Table 2.
Non-inferiority comparison of H. pylori eradication rates between the VA and VBQ groups.
| Analysis set | VBQ | VA | P-value for superiority | P-value for non-inferiority | Risk difference* |
|---|---|---|---|---|---|
| ITT | 83.4% (161/193) (95% CI: 78.2%, 88.7%) |
82.4% (159/193) (95% CI: 77.0%, 87.8%) |
0.787 | 0.010 | -1.04% (95% CI: -8.55%, 6.47%) |
| mITT | 90.4% (161/178) (95% CI: 86.1%, 94.8%) |
90.3% (159/176) (95% CI: 86.0%, 94.7%) |
0.972 | <0.001 | -0.11% (95% CI: -6.25%, 6.03%) |
| PP | 90.1% (155/172) (95% CI: 85.7%, 94.6%) |
90.5% (153/169) (95% CI: 86.1%, 94.9%) |
0.897 | <0.001 | 0.42% (95% CI: -5.86%, 6.69%) |
*Risk difference calculated as VA 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; VA, vonoprazan-amoxicillin dual therapy; ITT, intention-to-treat; mITT, modified intention-to-treat; PP, per-protocol.