Table 2.
Healing rates of gastric ulcers and duodenal ulcers during the 8‐week (GU) or 6‐week (DU) treatment period – FAS
| GU study (8 weeks) | DU study (6 weeks) | |||||
|---|---|---|---|---|---|---|
| Vonoprazan | Lansoprazole | Difference (Von.−Lans.) | Vonoprazan | Lansoprazole | Difference (Von.−Lans.) | |
| Week 2 | ||||||
| N | 231 | 225 | 178 | 180 | ||
| Healed, n (%) | 69 (29.9) | 73 (32.4) | −2.6 | 118 (66.3) | 115 (63.9) | 2.4 |
| 95% CI, lower, upper | 24.044, 36.221 | 26.373, 38.986 | −11.075, 5.926 | 58.839, 73.192 | 56.411, 70.901 | −7.469, 12.276 |
| Week 4 | ||||||
| N | 231 | 225 | 178 | 180 | ||
| Healed, n (%) | 169 (73.2) | 170 (75.6) | −2.4 | 167 (93.8) | 170 (94.4) | −0.6 |
| 95% CI, lower, upper | 66.955, 78.760 | 69.402, 81.023 | −10.407, 5.616 | 89.212, 96.875 | 90.021, 97.304 | −5.494, 4.245 |
| Study end | ||||||
| N | 231 | 225 | 178 | 180 | ||
| Healed, n (%) | 216 (93.5) | 211 (93.8) | −0.3 | 170 (95.5) | 177 (98.3) | −2.8 |
| 95% CI, lower, upper | 89.516, 96.320 | 89.780, 96.557 | −4.750, 4.208 | 91.337, 98.040 | 95.207, 99.655 | −6.400, 0.745 |
| Non‐inferioritya | ||||||
| P‐value | 0.0011 | 0.0654 | ||||
GU, gastric ulcer; DU, duodenal ulcer; FAS, full analysis set.
a
Farrington and Manning test with a non‐inferiority margin of 8% (GU) or 6% (DU).