Vonoprazan-amoxicillin dual therapy for Helicobacter pylori eradication in Chinese population: A prospective, multicenter, randomized, two-stage study

Table 1 Baseline characteristics of patients, n (%)

	Total	BQT	VAT-10	VAT-14	P value
Age (years, mean ± SD)	45.15 ± 12.53	43.84 ± 14.26	45.52 ± 11.26	45.69 ± 12.39	0.428
Range	12.00-80.00	15.00-72.00	27.00-80.00	12.00-77.00
Gender					0.027
Male	164 (53.59)	48 (51.06)	64 (64.00)	45 (45.45)
Female	142 (46.41)	46 (48.94)	36 (36.00)	54 (54.55)
Diagnosis					0.754
Peptic ulcer	42 (13.73)	15 (14.85)	12 (11.65)	15 (14.71)
Non-ulcer dyspepsia	264 (86.72)	86 (85.15)	91 (88.35)	87 (85.29)
Cigarette smoking	33 (10.78)	12 (12.77)	9 (9.00)	9 (9.09)	0.618
Alcohol drinking	14 (4.58)	6 (6.38)	4 (4.00)	3 (3.03)	0.524
Tea drinking	41 (13.40)	15 (15.96)	14 (14.00)	10 (10.10)	0.473
Coffee drinking	18 (5.88)	6 (6.38)	2 (2.00)	9 (9.09)	0.097
Family history of gastric cancer	17 (5.56)	4 (4.26)	4 (4.00)	5 (5.05)	0.940
H. pylori family gathering	51 (16.67)	15 (15.96)	15 (15.00)	19 (19.19)	0.581

H. pylori: Helicobacter pylori; VAT: Vonoprazan-amoxicillin dual therapy; BQT: Bismuth quadruple therapy.

Table 2 Adverse events for each regimen, n (%)

Adverse events	BQT	VAT-10	VAT-14	P value
				Total	BQT vs VAT-10	BQT vs VAT-14
Total	38 (37.62)	25 (25.27)	14 (13.73)	< 0.001	0.112	0.001
Bitter taste	19 (18.81)	4 (3.88)	6 (5.88)	< 0.001	0.005	0.019
Nausea	15 (14.85)	4 (3.88)	4 (3.92)	0.003	0.042	0.042
Dizziness	15 (14.85)	4 (3.88)	2 (1.96)	< 0.001	0.028	0.007
Diarrhea	11 (10.89)	4 (3.88)	10 (9.80)	0.144	-	-
Abdominal discomfort	11 (10.89)	1 (0.97)	4 (3.92)	0.005	0.020	0.206
Abdominal pain	10 (9.90)	4 (3.88)	7 (6.86)	0.236	-	-
Anorexia	10 (9.90)	3 (2.91)	2 (1.96)	0.022	0.158	0.107
Constipation	9 (8.91)	6 (5.83)	5 (4.90)	0.481	-	-
Belching	9 (8.91)	2 (1.94)	4 (3.92)	0.062	-	-
Vomiting	8 (7.92)	1 (0.97)	4 (3.92)	0.040	0.114	0.719
Skin rash	7 (6.93)	1 (0.97)	2 (1.96)	0.054	-	-
Bloating	7 (6.93)	6 (5.83)	4 (3.92)	0.638	-	-
Heartburn	7 (6.93)	1 (0.97)	3 (2.94)	0.060	-	-
Insomnia	6 (5.94)	1 (0.97)	3 (2.94)	0.107	-	-

VAT: Vonoprazan-amoxicillin dual therapy; BQT: Bismuth quadruple therapy.

Table 3 Remission of clinical symptoms for each regimen, n (%)

Remission	BQT	VAT-10	VAT-14	P value
				Total	BQT vs VAT-10	BQT vs VAT-14
Complete remission	41 (40.59)	46 (44.66)	60 (58.82)	< 0.001	1.000	0.014
Partial remission	42 (41.58)	30 (29.12)	34 (33.33)
No remission	18 (17.82)	27 (26.21)	8 (7.84)

VAT: Vonoprazan-amoxicillin dual therapy; BQT: Bismuth quadruple therapy.

Table 4 Cost-effectiveness analysis of each regimen

	BQT	VAT-10	VAT-14
Cost (CNY per percent)	334.18	216.80	163.52
Effectiveness (%)	80.90	94.00	93.90
CER (CNY per percent)	4.13	2.31	1.74
ICER (CNY per percent)		-1.82	-2.39

Effectiveness, the eradication rate in the per-protocol analysis (%). VAT: Vonoprazan-amoxicillin dual therapy; BQT: Bismuth quadruple therapy; CER: Cost-effectiveness ratio; Cost: Direct drug costs per patient; ICER: Incremental cost-effectiveness ratio.