Table 5.
Subgroup analysis of eradication rates between the VD and VBQ groups in treatment-naïve and rescue therapy patients.
| Analysis set | Subgroup | VBQ | VD | P-value for superiority | P-value for non-inferiority | Risk difference* |
|---|---|---|---|---|---|---|
| ITT | Treatment-naïve | 81.9% (145/177) (95% CI: 76.3%, 87.6%) |
78.8% (145/184) (95% CI: 72.9%, 84.7%) |
0.456 | 0.050 | -3.12% (95% CI: -11.30%, 5.07%) |
| mITT | Rescue therapy | 100.0% (16/16) (95% CI: 79.4%, 100.0%) |
88.9% (8/9) (95% CI: 68.4%, 100.0%) |
0.174 | 0.458 | -11.11% (95% CI: -31.64%, 9.42%) |
| Treatment-naïve | 89.5% (145/162) (95% CI: 84.8%, 94.2%) |
87.3% (145/166) (95% CI: 82.3%, 92.4%) |
0.542 | 0.013 | -2.16% (95% CI: -9.07%, 4.76%) |
|
| Rescue therapy | 100.0% (16/16) (95% CI: 79.4%, 100.0%) |
88.9% (8/9 (95% CI: 68.4%, 100.0%) |
0.174 | 0.458 | -11.11% (95% CI: -31.64%, 9.42%) |
|
| PP | Treatment-naïve | 89.2% (140/157) (95% CI: 84.3%, 94.0%) |
87.7% (142/162) (95% CI: 82.6%, 92.7%) |
0.672 | 0.009 | -1.52% (95% CI: -8.54%, 5.50%) |
| Rescue therapy | 100.0% (15/15) (95% CI: 78.2%, 100.0%) |
88.9% (8/9) (95% CI: 68.4%, 100.0%) |
0.188 | 0.458 | -11.11% (95% CI: -31.64%, 9.42%) |
*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.