Table 4.
Subgroup analysis of eradication rates between the VA and VBQ groups in treatment-naïve and rescue therapy patients.
| Analysis set | Subgroup | VBQ | VA | P-value for superiority | P-value for non-inferiority | Risk difference* |
|---|---|---|---|---|---|---|
| ITT | Treatment-naïve | 81.9% (145/177) (95% CI: 76.3%, 87.6%) |
83.2% (154/185) (95% CI: 77.9%, 88.6%) |
0.740 | 0.002 | 1.32% (95% CI: -6.49%, 9.14%) |
| Rescue therapy | 100.0% (16/16) (95% CI: 79.4%, 100.0%) |
62.5% (5/8) (95% CI: 29.0%, 96.0%) |
0.009 | 0.054 | -37.50% (95% CI: -71.05%, -3.95%) |
|
| mITT | Treatment-naïve | 89.5% (145/162) (95% CI: 84.8%, 94.2%) |
91.7% (154/168) (95% CI: 87.5%, 95.8%) |
0.501 | <0.001 | 2.16% (95% CI: -4.14%, 8.46%) |
| Rescue therapy | 100.0% (16/16) (95% CI: 79.4%, 100.0%) |
62.5% (5/8) (95% CI: 29.0%, 96.0%) |
0.009 | 0.054 | -37.50% (95% CI: -71.05%, -3.95%) |
|
| PP | Treatment-naïve | 89.2% (140/157) (95% CI: 84.3%, 94.0%) |
91.9% (149/162) (95% CI: 87.8%, 96.2%) |
0.391 | <0.001 | 2.80% (95% CI: -3.61%, 9.22%) |
| Rescue therapy | 100.0% (15/15) (95% CI: 78.2%, 100.0%) |
57.1% (4/7) (95% CI: 20.5%, 93.8%) |
0.006 | 0.040 | -42.86% (95% CI: -79.52%, -6.20%) |
*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.