Efficacy and safety of triple therapy with vonoprazan for Helicobacter pylori eradication: A multicenter, prospective, randomized controlled trial

Table 1 Baseline characteristics and demographics, n (%)

Characteristics	EBAC group (n = 175)	VACa group (n = 175)	VACb group (n = 174)
Age (year), mean ± SD	47.27 ± 11.48	48.20 ± 11.65	47.21 ± 11.70
Female sex	82 (46.9)	91 (52.0)	94 (54.0)
Married	170 (97.1)	162 (92.6)	161 (92.5)
Weight (kg), mean ± SD	68.36 ± 10.40	67.03 ± 10.95	66.74 ± 10.31
Height (cm), mean ± SD	168.18 ± 8.44	167.41 ± 7.49	167.36 ± 8.49
BMI, mean ± SD	24.12 ± 2.94	23.82 ± 2.85	23.78 ± 2.81
Smoking	19 (10.9)	14 (8.0)	16 (9.2)
Alcohol intake	54 (30.9)	43 (24.6)	46 (26.4)
High blood pressure	26 (14.9)	22 (12.6)	13 (7.5)
Diabetes	9 (5.1)	8 (4.6)	4 (2.3)
Family history of gastric cancer	14 (8.0)	9 (5.1)	6 (3.4)
History of peptic ulcer
No peptic ulcers	164 (93.7)	166 (94.9)	169 (97.1)
Gastric ulcer	5 (2.9)	7 (4.0)	4 (2.3)
Duodenal ulcer	6 (3.4)	2 (1.1)	1 (0.6)
Helicobacter pylori infection in family members	57 (32.6)	47 (26.9)	57 (32.8)

BMI: Body mass index; EBAC: Esomeprazole/bismuth/amoxicillin/clarithromycin; VACa: 14-day vonoprazan/amoxicillin/clarithromycin; VACb: 10-day vonoprazan/amoxicillin/clarithromycin.

Table 2 Difference in eradication rates of each therapy group

	EBAC	VACa	VACb	P value	χ2
ITT (%)	72.6	88.0	83.3	0.001	14.409
95%CI	66.0-79.2	83.2-92.8	77.8-88.9
n	127/175	154/175	145/174
PP (%)	81.4	93.9	90.6	0.001	13.341
95%CI	75.3-87.5	90.2-97.6	86.1-95.1
n	127/156	154/164	145/160

EBAC: Esomeprazole/bismuth/amoxicillin/clarithromycin; VACa: 14-day vonoprazan/amoxicillin/clarithromycin; VACb: 10-day vonoprazan/amoxicillin/clarithromycin; CI: Confidence interval; ITT: Intention-to-treat; PP: Per-protocol.

Table 3 Adverse events and patient compliance, n (%)

Adverse events	EBAC group (n = 175)	VACa group (n = 175)	VACb group (n = 174)	P value
Constipation	22 (12.6)	17 (9.7)	12 (6.9)
Diarrhea	9 (5.1)	10 (5.7)	9 (5.2)
Headache	7 (4.0)	5 (2.9)	7 (4.0)
Bitter/abnormal taste	3 (1.7)	5 (2.9)	2 (1.1)
Nausea	6 (3.4)	4 (2.3)	5 (2.9)
Bloating/indigestion	3 (1.7)	1 (0.6)	3 (1.7)
Anorexia	1 (0.6)	5 (2.9)	1 (0.6)
Gastrointestinal hemorrhage	1 (0.6)	1 (0.6)	3 (1.7)
Total	52 (36.6)	48 (33.8)	42 (29.6)	0.5
Unfinished studies	19 (10.9)	11 (6.3)	14 (8.0)	0.298

EBAC: Esomeprazole/bismuth/amoxicillin/clarithromycin; VACa: 14-day vonoprazan/amoxicillin/clarithromycin; VACb: 10-day vonoprazan/amoxicillin/clarithromycin.

Table 4 Noninferiority analysis of Helicobacter pylori eradication rates

	VACa	VACb
Differences from the EBAC group in ITT analysis	15.4	10.8
95%CI for difference	7.3-23.6	2.1-19.4
Noninferior P value	< 0.001a	0.018a
Differences from EBAC group in PP analysis	12.5	9.2
95%CI for difference	5.4-19.6	1.6-16.8
Noninferior P value	0.001a	0.014a

^aP < 0.025.

EBAC: Esomeprazole/bismuth/amoxicillin/clarithromycin; VACa: 14-day vonoprazan/amoxicillin/clarithromycin; VACb: 10-day vonoprazan/amoxicillin/clarithromycin; CI: Confidence interval; ITT: Intention-to-treat; PP: Per-protocol.