Table 1.
Demographic and baseline characteristics of Japanese patients randomized to treatment
| Lansoprazole (n = 185) | Gefarnate (n = 181) | P value | |
|---|---|---|---|
| Mean age (SD, years) | 62.8 (11.72) | 63.7 (11.05) | 0.4501 |
| Sex | 0.7811 | ||
| Male | 73 (39.5) | 74 (40.9) | |
| Female | 112 (60.5) | 107 (59.1) | |
| Current smoker | 55 (29.7) | 64 (35.4) | 0.2504 |
| Alcohol consumption | 63 (34.1) | 67 (37.0) | 0.5538 |
| Mean duration (SD) of prior NSAID (months)a | 21.8 (14.87) | 22.1 (14.37) | 0.8445 |
| Status of concomitant NSAID use | 0.7018 | ||
| Loxoprofen sodium hydrate | 72 (38.9) | 76 (42.0) | |
| Meloxicam | 30 (16.2) | 30 (16.6) | |
| Diclofenac sodium | 22 (11.9) | 27 (14.9) | |
| Etodolac | 24 (13.0) | 20 (11.0) | |
| Others | 37 (20.0) | 28 (15.5) | |
| Underlying diseaseb | |||
| Rheumatoid arthritis | 75 (40.5) | 76 (42.0) | 0.4174 |
| Osteoarthritis | 64 (34.6) | 66 (36.5) | 0.7087 |
| Low back pain | 6 (3.2) | 8 (4.4) | 0.5574 |
| Others | 85 (45.9) | 72 (39.8) | 0.2333 |
| H. pylori status | 0.3966 | ||
| Positive | 93 (50.3) | 99 (54.7) | |
| Negative | 92 (49.7) | 82 (45.3) | |
| CYP2C19 polymorphism | 0.5081 | ||
| PM | 32 (17.3) | 35 (19.3) | |
| EM | 137 (74.1) | 125 (69.1) | |
| Mean compliance rate (SD) | |||
| Study drug | 97.5 (11.1) | 97.9 (5.1) | 0.6570 |
| NSAID therapy | 93.1 (10.4) | 93.5 (6.3) | 0.6558 |
Data are presented as numbers (and % of total) except where otherwise indicated
Unknown in 37 patients for whom consent was not obtained for the CYP2C19 polymorphism test
PM poor metabolizers, EM extensive metabolizers
aThose who reported taking NSAIDs for >3 years prior to the start of the study medication were construed as having taken them for 3 years
bSome patients were included in more than one disease category. “Others” include treatments such as lumbar spinal stenosis or intervertebral disc hernia