Comparative study of esomeprazole and lansoprazole in triple therapy for eradication of Helicobacter pylori in Japan

Table 1 Participating hospitals attending the osaka gut forum

	Hospital	Patients (esomeprazole/lansoprazole)	%
1	Osaka Kaisei Hospital	52 (28/24)	19.4
2	Itami City Hospital	39 (20/19)	14.6
3	Osaka University Hospital	26 (12/14)	10.1
4	Osaka Seamen’s Insurance Hospital	24 (11/13)	9.0
5	Ashiya Municipal Hospital	17 (6/11)	6.3
6	Osaka General Medical Center	17 (7/10)	6.3
7	Yao Municipal Hospital	16 (9/7)	6.0
8	Osaka National Hospital	13 (7/6)	4.9
9	Sumitomo Hospital	11 (6/5)	4.1
10	Nishinomiya Municipal Central Hospital	9 (4/5)	3.4
11	Osaka Police Hospital	7 (3/4)	2.6
12	Higashiosaka City General Hospital	6 (2/4)	2.2
13	Ikeda Municipal Hospital	6 (3/3)	2.2
14	Toyonaka Municipal Hospital	6 (3/3)	2.2
15	Otemae Hospital	5 (3/2)	1.9
16	Hyogo Prefectural Nishinomiya Hospital	4 (2/2)	1.5
17	Osaka Medical Center for Cancer and Cardiovascular Disease	4 (1/3)	1.5
18	Minoh City Hospital	3 (1/2)	1.1
19	Osaka Rosai Hospital	2 (1/1)	0.7
20	Kansai Rosai Hospital	1 (0/1)	0.4
	Total	268 (134/134)	100

Table 2 Demographic and baseline characteristics of the study population

Characteristics	Total patients n = 268	Esomeprazole therapy n = 134	Lansoprazole therapy n = 134
Age (yr) (mean ± SD) range	61 ± 14 23-92	61 ± 13 25-84	61 ± 14 23-92
Sex, male, %	186, 69%	92, 69%	94, 70%
BMI (mean ± SD)	22.9 ± 3.5	22.7 ± 3.5	23.0 ± 3.5
Alcohol1, n, (%)	119, 44%	54, 42%	65, 49%
Smoking (%)	75, 28%	37, 28%	38, 28%
Underlying diseases
Hypertension, n, %	69, 26%	35, 26%	34, 25%
Diabetes mellitus, n, %	35, 13%	18, 13%	17, 13%
Lipid disorder, n, %	31, 12%	12, 9%	19, 14%
Chronic lung disease, n, %	7, 3%	4, 3%	3, 2%
Disease for H. pylori eradication
Gastric ulcer, n, %	163, 61%	82, 61%	81, 61%
Duodenal ulcer, n, %	59, 22%	29, 22%	30, 22%
Gastroduodenal ulcer, n, %	7, 3%	5, 4%	2, 1.5%
Gastric MALT lymphoma, n, %	2, 0.7%	0, 0%	2, 1.5%
ITP, n, %	1, 0.4%	1, 0.8%	0, 0%
EGC after endoscopic therapy, n, %	36, 13%	17, 13%	19, 14%
Therapy and test for H. pylori eradication
Clarithromycin 400 mg/800 mg per day	28/233	12/118	16/115
Urea breath test/stool antigen test/others	230/17/4	113/8/3	117/9/1
Compliance2
Good, n, %	226 (84%)	110 (82%)	116 (87%)

¹Alcohol habit was defined as drinking more than twice a week, consumption of more than 15 g of ethanol on each occasion in this study, 100 (%) If compliance was more than 75%, it graded as good;

²Compliance = actual number of internal use/14 (total number of internal use/7 d). BMI: Body mass index; MALT: Mucosa associated lymphoid tissue; ITP: Idiopathic thrombocytopenic purpura; EGC: Early gastric cancer; H. pylori: Helicobacter pylori.

Table 3 Univariate analysis of predictors for successful H.pylori eradication in per-protocol analysis

	OR	95%CI	P value
Sex
Male	1
Female	0.963	0.507-1.88	0.909
Age (yr)
< 60	1
≥ 60	1.1	0.594-2.09	0.754
Smoking
No	1
Yes	1.14	0.578-2.38	0.708
Drinking
No	1
Yes	0.644	0.347-1.18	0.157
BMI
< 25
≥ 25	0.73	0.361-1.52	0.387
Clarithromycin
400 mg/d	1
800 mg/d	1.96	0.752-4.75	0.162
Diabetes Mellitus
No	1
Yes	0.665	0.295-1.61	0.352
Hypertension
No	1
Yes	0.64	0.336-1.28	0.209
Lipid disorder
No	1
Yes	1.75	0.638-6.16	0.295
Chronic lung disease
No	1
Yes	1.68	0.278-32.0	0.616

BMI: Body mass index.

Table 4 Adverse effects in each therapy

Adverse events	Esomeprazole therapy				Lansoprazole therapy
	G1	G2	G3	Total, %	G1	G2	G3	Total, %
Diarrhea	32	3	1	36, 27%	33	7	1	41, 31%
Bitter taste	13	3	0	16, 12%	14	2	0	16, 12%
Nausea	1	0	0	1, 0.7%	1	0	0	1, 0.7%
Vomiting	2	0	1	3, 2.2%	0	0	0	0, 0%
Eruption	1	2	0	3, 2.2%	2	1	0	3, 2.2%
Headache	0	0	0	0, 0%	2	0	0	2, 1.5%
Fatigue	1	0	0	1, 0.7%	0	0	0	0, 0%
Appetite loss	2	1	0	3, 2.2%	1	0	0	1, 0.7%
Stomatitis	0	0	0	0, 0%	1	0	0	1, 0.7%
Cheilitis	0	0	0	0, 0%	2	0	0	2, 1.5%
Thirst	2	0	0	2, 1.5%	0	0	0	0, 0%
Belch	1	0	0	1, 0.7%	0	0	0	0, 0%
Bad breath	1	0	0	1, 0.7%	0	0	0	0, 0%
Sore throat	1	0	0	1, 0.7%	0	0	0	0, 0%
Joint paint	1	0	0	1, 0.7%	0	0	0	0, 0%
Leg edema	0	0	0	0, 0%	1	0	0	1, 0.7%
Chest discomfort	2	0	0	2, 1.5%	0	0	0	0, 0%
Floating	1	0	0	1, 0.7%	0	0	0	0, 0%
Abdominal wind	1	0	0	1, 0.7%	0	0	0	0, 0%
Constipation	2	0	0	2, 1.5%	2	0	0	2, 1.5%
Pruritus ani	0	0	0	0, 0%	1	0	0	1, 0.7%
Total	64	9	2	75, 56%	60	10	1	71, 53%