Randomized controlled trial to evaluate the efficacy and safety of fexuprazan compared with esomeprazole in erosive esophagitis

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 pylori2, 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.

¹LA 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).

²Two subjects (Fexuprazan 40 mg: 1 subject, Esomeprazole 40 mg: 1 subject) did not have H. pylori results at baseline.

³CYP2C19 genotype results were collected only from the subjects who agreed to the informed consent for genetic testing.

⁴Severity 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).

⁵Testing for difference between treatment groups after normality evaluation [Wilcoxon rank-sum test (w)].

⁶Testing 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.