Table 3.
Baseline characteristic | Recorded number of patients with gastric or duodenal ulcer | Cox regression analysis | ||
---|---|---|---|---|
Lansoprazole | Gefarnate | Hazard ratio (95% CI) | P value | |
H. pylori status | ||||
Positive | 6/81a | 27/87b | 0.1798 (0.0740–0.4369) | <0.0001 |
Negative | 9/87a | 19/75b | 0.3327 (0.1504–0.7361) | 0.0044 |
CYP2C19 | ||||
PM | 4/30c | 7/32d | 0.4675 (0.1360–1.6070) | 0.2167 |
EM | 10/124c | 30/112d | 0.2408 (0.1176–0.4929) | <0.0001 |
Age (years) | ||||
25–64 | 7/86 | 20/83 | 0.2254 (0.0946–0.5370) | 0.0002 |
65–85 | 8/82 | 26/79 | 0.2766 (0.1251–0.6112) | 0.0007 |
Smoking status | ||||
Yes | 5/48 | 19/60 | 0.2262 (0.0840–0.6088) | 0.0014 |
No | 10/120 | 27/102 | 0.2649 (0.1281–0.5481) | 0.0001 |
Alcohol consumption | ||||
Yes | 5/57 | 16/63 | 0.2873 (0.1048–0.7877) | 0.0096 |
No | 10/111 | 30/99 | 0.2377 (0.1161–0.4866) | <0.0001 |
Underlying disease | ||||
Rheumatoid arthritis | ||||
Yes | 7/68 | 21/67 | 0.2342 (0.0993–0.5522) | 0.0003 |
No | 8/100 | 25/95 | 0.2664 (0.1201–0.5913) | 0.0005 |
Osteoarthritis | ||||
Yes | 4/59 | 17/58 | 0.1904 (0.0640–0.5665) | 0.0009 |
No | 11/109 | 29/104 | 0.2860 (0.1426–0.5734) | 0.0002 |
Data are presented as numbers at risk
At risk: the number of patients at risk included all full analysis set patients who had at least one post-randomization endoscopy assessment, and had no acute-stage or healing-stage gastric or duodenal ulcer as confirmed by the Independent Adjudication Committee
Results of Cox regression analyses in lansoprazole or gefarnate group, respectively, between each group indicated (H. pylori-positive vs. -negative and CYP2C19 PM vs. EM); hazard ratio (95% CI) and P value
PM poor metabolizers, EM extensive metabolizers
a H. pylori-positive vs. -negative; 0.6306 (0.2240–1.7750), P = 0.3825
b H. pylori-positive vs. -negative; 1.1418 (0.6338–2.0571), P = 0.6588
cPM vs. EM; 0.6890 (0.2160–2.1977), P = 0.5291
dPM vs. EM; 1.2611 (0.5520–2.8812), P = 0.5821