Efficacy and safety of rabeprazole in non-steroidal anti-inflammatory drug-induced ulcer in Japan

Table 1 Demographic & baseline characteristics [Efficacy analysis (endoscopic evaluation: n = 38)]

Item		Subjects
		n	%
Age at baseline (yr)	20-39	0	0.0
	40-64	16	42.1
	≥ 65	22	57.9
Sex	Male	14	36.8
	Female	24	63.2
Diagnosis	Gastric ulcer	33	86.8
	Duodenal ulcer	3	7.9
	Gastric/duodenal ulcer	2	5.3
Ulcer history	Initial occurrence	15	39.5
	Reoccurrence	13	34.2
	Unknown	10	26.3
Prior history	No	28	73.7
	Yes	10	26.3
History of allergies	No	31	81.6
	Yes	5	13.2
	Unknown	2	5.3
Type of NSAID (duplicates included)	Diclofenac sodium	14	36.8
	Loxoprofen sodium	14	36.8
	Other	15	39.5
Anti-ulcer treatment before rabeprazole treatment (within 1 mo)	No	12	31.6
	Yes	26	68.4
Concomitant medication (not including NSAIDs)	No	5	13.2
	Yes	33	86.8
Endoscopic findings before start of treatment (ulcer size)	3 ≤ size < 10 mm	21	55.3
	10 ≤ size < 20 mm	13	34.2
	≥ 20 mm	4	10.5
Rabeprazole treatment duration	≤ 56 d	20	52.6
	> 56 d	18	47.4
Rabeprazole dosage	10 mg	24	63.2
	20 mg	12	31.6
	10 mg→20 mg	1	2.6
	20 mg→10 mg	1	2.6

Table 2 Endoscopic cure rate

	10 mg group	20 mg group	Modified dose group2	Total
Gastric ulcer1	71.4%	75.0%	50.0%	71.4%
	(15/21)	(9/12)	(1/2)	(25/35)
Duodenal ulcer	66.7%	-	-	66.7%
	(2/3)			(2/3)
Total	70.8%	75.0%	50.0%	71.1%
	(17/24)	(9/12)	(1/2)	(27/38)

¹The 2 patients with “gastric/duodenal ulcer” were included in tabulations for gastric ulcer;

²Modified dose group consisted of 1 patient changing from 10 mg to 20 mg and 1 patient changing from 20 mg to 10 mg.

Table 3 Demographic & baseline characteristics (Safety analysis: n = 64)

Item		Subjects
		n	%
Age at baseline (yr)	20-39	1	1.6
	40-64	34	53.1
	≥ 65	29	45.3
Sex	Male	27	42.2
	Female	37	57.8
Diagnosis	Gastric ulcer	57	89.1
	Duodenal ulcer	4	6.3
	Gastric/duodenal ulcer	2	3.1
	Anastomotic ulcer	1	1.6
Ulcer history	Initial occurrence	29	45.3
	Reoccurrence	20	31.3
	Unknown	15	23.4
Prior history	No	47	73.4
	Yes	17	26.6
History of allergies	No	55	85.9
	Yes	6	9.4
	Unknown	3	4.7
Type of NSAID (duplicates included)	Diclofenac sodium	34	53.1
	Loxoprofen sodium	20	31.3
	Other	27	42.2
Anti-ulcer treatment before rabeprazole treatment (within 1 mo)	No	19	29.7
	Yes	45	70.3
Concomitant medication (not including NSAIDs)	No	7	10.9
	Yes	57	89.1
Endoscopic findings before start of treatment (ulcer size)	3 ≤ size < 10 mm	31	48.4
	10 ≤ size < 20 mm	25	39.1
	≥ 20 mm	5	7.8
	Unknown	3	4.7
Rabeprazole treatment duration	≤ 56 d	27	42.2
(gastric ulcer, gastric/duodenal ulcer, duodenal ulcer, anastomotic ulcer)	> 56 d	37	57.8
Rabeprazole dosage	10 mg	39	60.9
	20 mg	19	29.7
	10 mg→20 mg	1	1.6
	20 mg→10 mg	5	7.8

Table 4 Clinical characteristics of NSAIDs-induced ulcer (safety analysis: n = 64)

Site of ulcer	n	%	Ulcer form	n	%	No. of ulcers	n	%
Ulcer condition
Corpus	19	29.7	Round	27	42.2	Single	42	65.6
Angle	7	10.9	Elliptical	23	35.9	Multiple	21	32.8
Antrum	31	48.4	Irregular	11	17.2
Bulb	4	6.3	Other	2	3.1
Efferent loop	1	1.6