Safety and effectiveness of vonoprazan-based rescue therapy for Helicobacter pylori infection

Table 1 Clinicodemographic characteristics of the study patients, n (%)

Characteristic	Total No. of patients (n = 68)	Number of prior eradication failures
		1 (n = 47)	2 (n = 15)	3 (n = 6)
Sex (male)	20 (29.4)	10 (21.3)	6 (4.0)	4 (66.7)
Age (yr), mean ± SD	49.60 ± 10.57	49.94 ± 10.00	48.87 ± 12.65	48.83 ± 11.27
Height (m), mean ± SD	1.63 ± 0.07	1.62 ± 0.09	1.64 ± 0.08	1.68 ± 0.10
Weight (kg), mean ± SD	59.52 ± 12.30	56.83 ± 12.19	63.80 ± 9.94	69.92 ± 11.50
BMI (kg/m2), mean ± SD	22.31 ± 3.64	21.59 ± 3.98	23.63 ± 2.04	24.63 ± 1.80
Lifestyle factors
Smoking	5 (7.3)	4 (8.5)	0 (0)	1 (16.7)
Drinking	4 (5.9)	0 (0)	1 (6.7)	3 (50.0)
Symptom
Abdominal pain	7 (10.3)	5 (10.6)	2 (13.3)	0 (0)
Bloating	6 (8.8)	4 (8.5)	2 (13.3)	0 (0)
Diarrhea	1 (1.5)	0 (0)	1 (6.7)	0 (0)
Halitosis	1 (1.5)	1 (2.1)	0 (0)	0 (0)
Belching	13 (19.1)	8 (17.0)	3 (20.0)	2 (33.4)
Nausea	2 (2.9)	2 (4.3)	0 (0)	0 (0)
Bitter taste	1 (1.5)	1 (2.1)	0 (0)	0 (0)
Asymptomatic	37 (54.4)	26 (55.3)	7 (46.7)	4 (66.7)
Concomitant disease
Diabetes mellitus	9 (13.2)	8 (17.0)	1 (6.7)	0 (0)
Hypertension	14 (20.6)	7 (14.9)	5 (33.3)	2 (33.4)
Anxiety disorder	4 (5.9)	1 (2.1)	2 (13.3)	1 (16.7)
Gastroscopy findings
Atrophic gastritis	33 (48.6)	27 (57.4)	4 (26.7)	2 (33.4)
Non-atrophic gastritis	24 (35.3)	14 (29.8)	8 (53.3)	2 (33.4)
Peptic ulcer	4 (5.9)	1 (2.1)	1 (6.7)	2 (33.4)
Polyp	1 (1.5)	0 (0)	1 (6.7)	0 (0)
Not applicable (no gastroscopy done)	6 (8.9)	5 (10.6)	1 (13.3)	0 (0)

BMI: Body mass index.

Table 2 Factors potentially influencing Helicobacter pylori eradication, n (%)

Factor	Eradication failure (n = 5)	Successful eradication (n = 63)	P value
Sex (male)	2 (40.0)	18 (28.6)	0.627
Age (yr), mean ± SD	54.40 ± 5.86	49.22 ± 10.80	0.295
Height (m), mean ± SD	1.62 ± 0.10	1.62 ± 0.07	0.778
Weight (kg), mean ± SD	64.60 ±11.42	59.12 ± 12.37	0.129
BMI (kg/m2), mean ± SD	24.43 ± 1.88	22.14 ± 3.70	0.112
Concomitant disease
Diabetes mellitus	1 (20.0)	8 (12.7)	0.520
Hypertension	1 (20.0)	13 (20.6)	1.000
Anxiety disorder	2 (40.0)	2 (3.2)	0.025
Gastroscopy findings
Atrophic gastritis	2 (40.0)	31 (49.2)	1.000
Non-atrophic gastritis	3 (60.0)	21 (33.3)	0.337
Peptic ulcer	0 (0.0)	4 (6.3)	1.000
Polyp	0 (0.0)	1 (1.6)	1.000
No. of prior treatments
1	3 (60.0)	44 (69.8)	0.641
≥ 2	2 (40.0)	19 (30.2)

BMI: body mass index.

Table 3 Adverse events and patient compliance

Variable	%
Adverse events
Total adverse events	14.7% (10/68)
Dry mouth	1.5% (1/68)
Skin rash	4.4% (3/68)
Bloating	1.5% (1/68)
Diarrhea	5.9% (4/68)
Abdominal pain	1.5% (1/68)
Grade of adverse event
Mild	70.0% (7/10)
Moderate	30.0% (3/10)
Severe	0% (0/10)
1Compliance
Good	95.6% (65/68)
Poor	4.4% (3/68)

¹Compliance was rated as good if the patient had taken > 80% of all medications prescribed, and as poor, if not.

Table 4 Comparison of liver and kidney function before and after treatment

Characteristic	Before (n = 41)	After (n = 41)	P value
Total bilirubin (μmol/L), mean ± SD	13.68 ± 4.82	14.96 ± 5.22	0.252
ALT (U/L), mean ± SD	16.92 ± 8.33	21.46 ± 16.03	0.270
AST (U/L), mean ± SD	18.99 ± 7.61	21.03 ± 10.67	0.670
Creatinine (μmol/L), mean ± SD	60.105 ± 12.060	60.53 ± 11.35	0.974

AST: Aspartate transaminase; ALT: Alanine transaminase.