Real-world evidence on the efficacy and safety of vonoprazan-amoxicillin dual therapy for Helicobacter pylori treatment in elderly patients

Table 1 Demographic and clinical data of all patients, n (%)

Characteristics	First-line treatment, n = 250	Rescue treatment, n = 130	P value
Age in years	65.3 ± 4.4	65.1 ± 3.6	0.6000
Range	60-82	60-76
Sex as M/F	106/144	60/70	0.5500
Body weight in kg	65.5 ± 11.3	65.8 ± 10.8	0.8000
BMI in kg/m2	24.0 ± 3.4	23.7 ± 2.9	0.3700
Cigarette smoking	31 (12.4)	15 (11.5)	0.9300
Alcohol drinking	35 (14.0)	27 (20.8)	0.1200
Family history of gastric cancer	15 (6.0)	15 (11.5)	0.0900
Endoscopy diagnosis
Gastritis	193 (77.2)	97 (77.2)	0.6600
CSG	108 (43.2)	32 (24.6)	0.0006c
CAG	85 (34.0)	65 (50.0)	0.0035b
Peptic ulcer	51 (20.4)	27 (20.8)	1.0000
Gastric ulcer	14 (5.6)	11 (4.4)	0.4000
Duodenal ulcer	27 (10.8)	16 (6.4)	0.7900
Complex (gastric and duodenal) ulcer	10 (4.0)	0 (0.0)	0.0180a
Gastric cancer	1 (0.4)	1 (0.8)	1.0000
MALToma	3 (1.2)	0 (0.0)	0.5500
Gastric hyperplastic polyp	2 (0.8)	5 (3.8)	0.0490a
Combined diseases	1.8 ± 1.4	1.8 ± 1.4	0.9020
0	53 (21.2)	26 (20.0)	0.8900
1	61 (24.4)	34 (26.1)	0.8000
2	64 (25.6)	35 (26.9)	0.8800
≥ 3	72 (28.8)	35 (16.9)	0.7900
Combined medicine	1.3 ± 1.6	1.5 ± 1.7	0.3400
0	99 (39.6)	45 (34.6)	0.4000
1	59 (23.6)	36 (27.7)	0.4500
2	40 (16.0)	17 (13.1)	0.5400
≥ 3	52 (20.8)	32 (24.6)	0.4700
Comorbidity
Hypertension	89 (35.6)	49 (37.7)	0.7700
Diabetes mellitus	45 (18.0)	20 (15.4)	0.6200
Hyperlipidemia	88 (35.2)	33 (25.4)	0.0700
Heart disease	32 (12.8)	15 (11.5)	0.8500
Lung disease	10 (4.0)	5 (3.8)	1.0000
Liver disease	28 (11.2)	12 (9.2)	0.6800
Renal disease	13 (5.2)	7 (5.4)	1.0000
Cerebrovascular disease	10 (4.0)	7 (5.4)	0.6000
Autoimmune disease	24 (9.6)	9 (6.9)	0.4500
Hypersensitivity disease	4 (1.6)	4 (3.1)	0.4500
Other malignant tumor	25 (10.0)	19 (14.6)	0.2400
Adherence	247 (98.8)	128 (98.5)	1.0000
Adverse events	23 (9.2); 95%CI: 6.2%-13.4%	13 (10.0); 95%CI: 4.8%-15.2%	1.0000
Eradication rate	95.6% (239/250); 95%CI: 93.0%-98.1%	89.2% (116/130); 95%CI: 83.9%-94.6%	0.0300a

^aP < 0.05.

^bP < 0.01.

^cP < 0.001.

Data are mean ± SD unless otherwise indicated. Cigarette smoking was defined by consumption of > 5 cigarettes a day or > 1 cigarette pack/week consumed in the past 6 months. A family history of gastric cancer was defined as a gastric cancer diagnosis in a first-degree relative (such as a parent, sibling, or child). Alcohol drinking was defined by > 50 g of alcohol/day consumed in the past 6 months. Compliance was defined by > 80% of tablets taken as instructed. BMI: Body mass index; CSG: Chronic superficial gastritis; CAG: Chronic astrophic gastritis; F: Female; M: Male; MALToma: Mucosa-associated lymphoid tissue lymphoma.

Table 2 Characteristics of patients undergoing first-line treatment with successful and failed eradication, n (%)

Characteristic	Total, n = 250	VA success, n = 239	VA failure, n = 11	P value
Age in years	65.3 ± 4.4	65.4 ± 4.4	63.4 ± 4.1	0.1500
Range	60-82	60-82	60-72
Sex as M/F	106/144	103/136	3/8	0.3600
Body weight in kg	65.5 ± 11.3	65.4 ± 11.1	67.4 ± 14.4	0.6400
BMI in kg/m2	24.0 ± 3.4	23.99 ± 11.1	24.8 ± 3.7	0.5000
Cigarette smoking	31 (12.4)	30 (12.5)	1 (9.1)	1.0000
Alcohol drinking	35 (14.0)	34 (14.2)	1 (9.1)	1.0000
Family history of gastric cancer	15 (6.0)	14 (5.9)	1 (9.1)	0.5000
Endoscopy diagnosis
Gastritis	193 (77.2)	183 (76.6)	10 (90.9)	0.7000
CSG	108 (43.2)	105 (43.9)	3 (27.3)	0.3500
CAG	85 (34.0)	78 (32.6)	7 (63.6)	0.0490a
Peptic ulcer	51 (20.4)	50 (20.9)	1 (9.1)	0.4700
Gastric ulcer	14 (5.6)	14 (5.9)	0	1.0000
Duodenal ulcer	27 (10.8)	26 (10.9)	1 (9.1)	1.0000
Complex (gastric and duodenal) ulcer	10 (4.0)	10 (4.2)	0	1.0000
Gastric cancer	1 (0.4)	1 (0.4)	0	1.0000
MALToma	3 (1.2)	3 (1.3)	0	1.0000
Gastric hyperplastic polyp	2 (0.8)	2 (0.8)	0	1.0000
Combined diseases	1.8 ± 1.4	1.8 ± 1.4	1.5 ± 1.4	0.4300
0	53 (21.2)	50 (20.9)	3 (27.3)	0.7100
1	61 (24.4)	57 (23.8)	4 (36.4)	0.4700
2	64 (25.6)	63 (26.4)	1 (9.1)	0.3000
≥ 3	72 (28.8)	69 (28.9)	3 (27.3)	1.0000
Combined medicine	1.3 ± 1.6	1.4 ± 1.6	0.7 ± 1.2	0.1100
0	99 (39.6)	92 (38.5)	7 (63.6)	0.1200
1	59 (23.6)	57 (23.8)	2 (18.2)	1.0000
2	40 (16.0)	40 (16.7)	0	0.2200
≥ 3	52 (20.8)	50 (20.9)	2 (18.2)	0.1300
Comorbidity
Hypertension	89 (35.6)	86 (36.0)	3 (27.3)	0.7500
Diabetes mellitus	45 (18.0)	44 (18.4)	1 (9.1)	0.6900
Hyperlipidemia	88 (35.2)	85 (35.6)	3 (27.3)	0.7500
Heart disease	32 (12.8)	32 (13.4)	0	0.3800
Lung disease	10 (4.0)	10 (4.2)	0	1.0000
Liver disease	28 (11.2)	26 (10.9)	2 (18.2)	0.3500
Renal disease	13 (5.2)	12 (5.0)	1 (9.1)	0.4500
Cerebrovascular disease	10 (4.0)	10 (4.2)	0	1.0000
Autoimmune disease	24 (9.6)	22 (9.2)	2 (18.2)	0.2900
Hypersensitivity disease	4 (1.6)	4 (1.7)	0	1.0000
Malignant tumor	25 (10.0)	22 (9.2)	3 (27.3)	0.0900
Compliance	246 (98.4)	238 (99.6)	8 (72.7)	0.0003c
Adverse events	23 (9.2); 95%CI: 6.2%-13.4%	21 (8.8)	2 (18.2)	0.2900
Eradication rate	95.6% (239/250); 95%CI: 93.0%-98.1%

^aP < 0.05.

^cP < 0.001.

Data are mean ± SD unless otherwise indicated. Cigarette smoking was defined by consumption of > 5 cigarettes a day or > 1 cigarette pack/week consumed in the past 6 months. A family history of gastric cancer was defined as a gastric cancer diagnosis in a first-degree relative (such as a parent, sibling, or child). Alcohol drinking was defined by > 50 g of alcohol/day consumed in the past 6 months. Compliance was defined by > 80% of tablets taken as instructed. BMI: Body mass index; CSG: Chronic superficial gastritis; CAG: Chronic astrophic gastritis; F: Female; M: Male; MALToma: Mucosa-associated lymphoid tissue lymphoma; VA: Vonaprazan-amoxicillin.

Table 3 Cure rate of patients who stopped treatment prematurely by group

Group	No.	Sex	Age in years	Duration of medication in days	Symptom of AE	Successful eradication	Cure rate
First-line treatment, n = 4	008	M	67	10	Forgot1	No	1/4
	079	F	62	7	Abdominal pain	No
	090	F	72	7	Skin rash	No
	242	F	79	4	Skin rash	Yes
Rescue treatment, n = 2	073	F	68	10	Abdominal discomfort	Yes	2/2
	122	F	60	10	Skin rash	Yes

¹Forgot to take the medication due to drinking alcohol.

AE: Adverse event; F: Female; M: Male.

Table 4 Characteristics of patients undergoing rescue therapy with successful and failed eradication, n (%)

Characteristic	Total, n = 130	VA success, n = 116	VA failure, n = 14	P value
Age in years	65.1 ± 3.6	65.0 ± 3.6	66.3 ± 3.3	0.180
Range	60-76	60-76	60-72
Sex as M/F	60/70	53/63	7/7	0.780
Weight in kg	65.8 ± 10.8	65.4 ± 10.4	68.8 ± 13.6	0.390
BMI in kg/m2	23.7 ± 2.9	23.6 ± 2.8	24.7 ± 4.0	0.320
Cigarette smoking	15 (11.5)	11 (9.5)	4 (28.6)	0.058
Alcohol drinking	27 (20.8)	24 (20.7)	3 (21.4)	1.000
Family history of gastric cancer	15 (11.5)	12 (10.3)	3 (21.4)	0.210
Endoscopy diagnosis
Gastritis	97 (77.2)	90 (77.6)	7 (50.0)	0.045a
CSG	32 (24.6)	30 (25.9)	2 (14.3)	0.520
CAG	65 (50.0)	60 (51.7)	5 (35.7)	0.400
Peptic ulcer	27 (20.8)	21 (18.1)	6 (42.8)	0.070
Gastric ulcer	11 (4.4)	7 (6.0)	4 (28.6)	0.018a
Duodenal ulcer	16 (6.4)	14 (12.1)	2 (14.3)	0.680
Complex (gastric and duodenal) ulcer	0	0	0	1.000
Gastric cancer	1 (0.8)	0	1 (7.1)	0.110
MALToma	0	0	0	1.000
Gastric hyperplastic polyp	5 (3.8)	5 (4.3)	0	1.000
Combined diseases	1.8 ± 1.4	1.7 ± 1.3	2.1 ± 2.0	0.540
0	26 (20.0)	24 (20.7)	2 (14.3)	0.740
1	34 (26.1)	28 (24.1)	6 (42.8)	0.190
2	35 (26.9)	34 (29.3)	1 (7.1)	0.110
≥ 3	35 (16.9)	30 (25.9)	5 (35.7)	0.520
Combined medicine	1.5 ± 1.7	1.5 ± 1.7	1.9 ± 2.4	0.490
0	45 (34.6)	40 (34.5)	5 (35.7)	1.000
1	36 (27.7)	33 (28.4)	3 (21.4)	0.760
2	17 (13.1)	15 (12.9)	2 (14.3)	1.000
≥ 3	32 (24.6)	28 (24.1)	4 (28.6)	0.750
Comorbidity
Hypertension	49 (37.7)	43 (37.1)	6 (42.8)	0.770
Diabetes mellitus	20 (15.4)	17 (14.7)	3 (21.4)	0.450
Hyperlipidemia	33 (25.4)	29 (25.0)	4 (28.6)	0.750
Heart disease	15 (11.5)	13 (11.2)	2 (14.3)	0.660
Lung disease	5 (3.8)	5 (4.3)	0	1.000
Liver disease	12 (9.2)	9 (7.8)	3 (21.4)	0.120
Renal disease	7 (5.4)	7 (6.0)	0	1.000
Cerebrovascular disease	7 (5.4)	7 (6.0)	0	1.000
Autoimmune disease	9 (6.9)	9 (7.8)	0	0.600
Hypersensitivity disease	4 (3.1)	4 (3.4)	0	1.000
Malignant tumor	19 (14.6)	17 (14.7)	2 (14.3)	1.000
Compliance	128 (98.5)	114 (98.3)	14 (100)	1.000
Adverse events	13 (10.0); 95%CI: 4.8%-15.2%	13 (11.2)	0	0.360
Eradication rate	89.2% (116/130); 95%CI: 83.9-94.6%

^aP < 0.05.

Data are mean ± SD unless otherwise indicated. Cigarette smoking was defined by consumption of > 5 cigarettes a day or > 1 cigarette pack/week consumed in the past 6 months. A family history of gastric cancer was defined as a gastric cancer diagnosis in a first-degree relative (such as a parent, sibling, or child). Alcohol drinking was defined by > 50 g of alcohol/day consumed in the past 6 months. Compliance was defined by > 80% of tablets taken as instructed. BMI: Body mass index; CSG: Chronic superficial gastritis; CAG: Chronic astrophic gastritis; F: Female; M: Male; MALToma: Mucosa-associated lymphoid tissue lymphoma; VA: Vonaprazan-amoxicillin.

Table 5 Adverse events in each group, n (%)

Symptom	First-line, n = 250	Rescue, n = 130	Total, n = 380	Nonadherence due to AE	Failed in treatment
Skin rash	5 (2.0)	3 (2.3)	8 (2.1)	3	1
Abdominal pain	5 (2.0)	2 (1.5)	7 (1.8)	1	1
Abdominal discomfort	3 (1.2)	4 (3.1)	7 (1.8)	1	0
Diarrhea	4 (1.6)	1 (0.8)	5 (1.3)	0	0
Vomiting	3 (1.2)	0	3 (0.8)	0	0
Increased bowl movement	1 (0.4)	1 (0.8)	2 (0.5)	0	0
Abdominal distension	2 (0.8)	0	2 (0.5)	0	0
Constipation	1 (0.4)	1 (0.8)	2 (0.5)	0	0
Heartburn	1 (0.4)	0	1 (0.3)	0	0
Itchy skin	1 (0.4)	0	1 (0.3)	0	0
Nausea	1 (0.4)	0	1 (0.3)	0	0
Fever	1 (0.4)	0	1 (0.3)	0	0
Headache	0	1 (0.8)	1 (0.3)	0	0
Dizziness	1 (0.4)	0	1 (0.3)	0	0
Blood pressure decrease	1 (0.4)	0	1 (0.3)	0	0
Total AE	23 (9.2)	13 (10.0)	36 (9.5)	5	2
Adherence	247 (98.8)	128 (98.5)	375 (98.7)

AE: Adverse event.