Table 1.
Baseline characteristics of the patients (full analysis set)
| Variables | Fexuprazan 40 mg (n = 116) | Esomeprazole 40 mg (n = 115) | P value | |
| Age, yr (mean ± SD)5 | 53.70 ± 12.44 | 55.05 ± 12.89 | 0.343w | |
| Sex, n (%)6 | ||||
| Men | 78 (67.2) | 74 (64.3) | 0.643c | |
| Women | 38 (32.8) | 41 (35.7) | ||
| BMI, kg/m2 (SD)5 | 24.42 ± 3.08 | 24.81 ± 3.25 | 0.529w | |
| Smoking history, n (%)6 | ||||
| Non-smokers | 67 (57.8) | 66 (57.4) | 0.978c | |
| Current smokers | 25 (21.6) | 26 (22.6) | ||
| Past smokers | 24 (20.7) | 23 (20.0) | ||
| Drinking history, n (%)6 | ||||
| Non-drinkers | 15 (12.9) | 15 (13.0) | 0.992c | |
| Current drinkers | 77 (66.4) | 77 (67.0) | ||
| Past drinkers | 24 (20.7) | 23 (20.0) | ||
| LA classification1, n (%)6 | ||||
| Grade A | 75 (64.7) | 76 (66.1) | 0.630f | |
| Grade B | 33 (28.4) | 31 (27.0) | ||
| Grade C | 6 (5.2) | 8 (7.0) | ||
| Grade D | 2 ( 1.7) | 0 (0.0) | ||
| Helicobacter pylori 2, n (%)6 | ||||
| Positive | 20 (17.4) | 31 (27.2) | 0.075c | |
| Negative | 95 (82.6) | 83 (72.8) | ||
| CYP2C193, n (%)6 | ||||
| EM | 39 (76.5) | 53 (94.6) | 0.007c | |
| PM | 12 (23.5) | 3 (5.4) | ||
| Severity for heartburn4, n (%)6 | ||||
| Mild | 53 (45.7) | 50 (43.5) | 0.735c | |
| Moderate/severe | 63 (54.3) | 65 (56.5) | ||
Values are mean SD or the number of the patients with percentage, where appropriate.
LA Classification (Grade A: One (or more) mucosal break(s) no longer than 5 mm, that does not extend between the tops of two mucosal folds, Grade B: One (or more) mucosal break(s) more than 5 mm long, that does not extend between the tops of two mucosal folds, Grade C: One (or more) mucosal break(s) that is continuous between the tops of two or more mucosal folds, but which involve(s) less than 75% of the oesophageal circumference, Grade D: One (or more) mucosal break(s) which involve(s) at least 75% of the oesophageal circumference).
Two subjects (Fexuprazan 40 mg: 1 subject, Esomeprazole 40 mg: 1 subject) did not have H. pylori results at baseline.
CYP2C19 genotype results were collected only from the subjects who agreed to the informed consent for genetic testing.
Severity for heartburn was defined based on the baseline Reflux disease questionnaire (RDQ). Mild: RDQ ≤ 2 (Less than or equal to 1 d out of 7 d), Moderate/Severe: RDQ ≥ 3 (Greater than or equal to 2 d out of 7 d).
Testing for difference between treatment groups after normality evaluation [Wilcoxon rank-sum test (w)].
Testing for difference among treatment groups [Chi-square test (c) or Fisher's exact test (f)].
BMI: Body mass index; LA: Los-Angeles; CYP2C19: Cytochrome P 2C19; EM: Extensive metabolizer; PM: Poor metabolizer.