Comparing fexuprazan and rabeprazole for treating peptic ulcer: A multicenter, randomized controlled trial

Table 1 Patient baseline characteristics (per protocol set), n (%)/mean ± SD

Characteristics	Fexuprazan 40 mg (n = 51)	Rabeprazole 20 mg (n = 51)	P value
Age (year)	55.45 ± 10.81	52.71 ± 11.70	0.221
Gender			0.108
Male	34 (66.67)	26 (50.98)
Female	17 (33.33)	25 (49.02)
Height (cm)	167.50 ± 9.57	165.51 ± 8.73	0.274
Body weight (kg)	67.67 ± 15.12	67.18 ± 13.41	0.863
BMI (kg/m2)	23.91 ± 3.87	24.38 ± 3.64	0.527
Smoking			0.832
Yes	16 (31.37)	17 (33.33)
No	35 (68.63)	34 (66.67)
Alcohol			0.426
Yes	25 (49.02)	21 (41.18)
No	26 (50.98)	30 (58.82)
Helicobacter pylori infection			0.164
Yes	24 ± 47.06	31 ± 60.78
No	27 ± 52.94	20 ± 39.22
Ulcer size (cm)	1.03 ± 0.44	1.05 ± 0.41	0.888
Ulcer size category (cm)
0.5-1	34 (66.67)	33 (64.71)	0.834
1-2	16 (31.37)	18 (35.29)
2-3	1 (1.96)	0 (0.00)

BMI: Body mass index.

Table 2 Absolute risk differences of ulcer healing rates at week 4 and week 8, n (%)

Analysis set	Time point	Fexuprazan 40 mg	Rabeprazole 20 mg	Difference (95%CI)	P value1
Per protocol set	8 weeks	51/51 (100)	50/51 (98.04)	1.96 (-1.84 to 5.77)	< 0.0001
	4 weeks	50/51 (98.04)	48/51 (94.12)	3.92 (-3.57 to 11.42)	0.0001
Full analysis set	8 weeks	51/52 (98.08)	50/51 (98.04)	0.04 (-5.29 to 5.37)	0.0001
	4 weeks	50/52 (96.15)	48/51 (94.12)	2.04 (-6.27 to 10.34)	0.0023

¹Non-inferiority test.

Difference = fexuprazan – rabeprazole. The 95%CI was calculated by Wald method. In all analyses, the lower limit of the 95%CI exceeded the non-inferiority margin of -10%.

Table 3 Ulcer healing rates by Helicobacter pylori status at week 4 and week 8 (per protocol set), n (%)

Healed patients	H. pylori negative (n = 47)			H. pylori positive (n = 55)
	Fexuprazan 40 mg (n = 27)	Rabeprazole 20 mg (n = 20)	P value1	Fexuprazan 40 mg (n = 24)	Rabeprazole 20 mg (n = 31)	P value1
At 4 weeks
Yes	26 (96.30)	18 (90.00)	0.567	24 (100)	30 (96.77)	> 0.999
No	1 (3.70)	2 (10.00)		0 (0.00)	1 (3.23)
P value2						0.969
At 8 weeks
Yes	27 (100)	19 (95.00)	0.426	24 (100)	31 (100)	-
No	0 (0.00)	1 (5.00)		0 (0.00)	0 (0.00)
P value2						0.972

¹χ² test or Fisher’s exact test.

²The interaction between treatment group and Helicobacter pylori infection was assessed using logistic regression.

H. pylori: Helicobacter pylori.

Table 4 Summary of treatment-emergent adverse events (per safety set), n (%)

	Fexuprazan 40 mg (n = 52)	Rabeprazole 20 mg (n = 54)	P value1
TEAE	3 (5.77)	2 (3.70)	0.676
95%CI	1.20-15.95	0.45-12.75
Serious TEAE	0 (0.00)	0 (0.00)
Drug-related TEAE	0 (0.00)	2 (3.70)	0.495
95%CI	-	0.45-12.75
Serious drug-related TEAE	0 (0.00)	0 (0.00)

¹Fisher’s exact test.

TEAE: Treatment-emergent adverse event.