title: Long-term efficacy and safety of rabeprazole in patients taking low-dose aspirin with a history of peptic ulcers: a phase 2/3, randomized, parallel-group, multicenter, extension clinical trial.
abstract: A 24-week, double-blind, clinical trial of rabeprazole for the prevention of recurrent peptic ulcers caused by low-dose aspirin (LDA) has been reported, but trials for longer than 24 weeks have not been reported. The aim of this study is to assess the long-term efficacy and safety of rabeprazole for preventing peptic ulcer recurrence on LDA therapy. Eligible patients had a history of peptic ulcers on long-term LDA (81 or 100 mg/day) therapy. Patients with no recurrence of peptic ulcers at the end of the 24-week double-blind phase with rabeprazole (10- or 5-mg once daily) or teprenone (50 mg three times daily) entered the extension phase. Rabeprazole doses were maintained for a maximum of 76 weeks, including the double-blind 24-week period and the extension phase period (long-term rabeprazole 10- and 5-mg groups). Teprenone was randomly switched to rabeprazole 10 or 5 mg for a maximum of 52 weeks in the extension phase (newly-initiated rabeprazole 10- and 5-mg groups). The full analysis set consisted of 151 and 150 subjects in the long-term rabeprazole 10- and 5-mg groups, respectively, and the cumulative recurrence rates of peptic ulcers were 2.2 and 3.7%, respectively. Recurrent peptic ulcers were not observed in the newly-initiated rabeprazole 10- and 5-mg groups. No bleeding ulcers were reported. No clinically significant safety findings, including cardiovascular events, emerged. The use of long-term rabeprazole 10- and 5-mg once daily prevents the recurrence of peptic ulcers in subjects on low-dose aspirin therapy, and both were well-tolerated.
authors.affiliation: Department of Endoscopy and Endoscopic Surgery, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan.
authors.forename: Mitsuhiro
authors.initials: M
authors.lastname: Fujishiro
authors.affiliation: Second Department of Internal Medicine, Osaka Medical College, 2-7 Daigaku-cho, Takatsuki, Osaka 569-8686, Japan.
authors.forename: Kazuhide
authors.initials: K
authors.lastname: Higuchi
authors.affiliation: Division of Endoscopy, Hokkaido University Hospital, Nishi 5-chome, Kita 14-jou, Kita-ku, Sapporo, Hokkaido 060-8648, Japan.
authors.forename: Mototsugu
authors.initials: M
authors.lastname: Kato
authors.affiliation: Department of Internal Medicine II, Faculty of Medicine, Shimane University, 89-1 Enya-cho, Izumo, Shimane 693-8501, Japan.
authors.forename: Yoshikazu
authors.initials: Y
authors.lastname: Kinoshita
authors.affiliation: Department of Internal Medicine & Gastrointestinal Endoscopy, Saga Medical School, 5-1-1 Nabeshima, Saga 849-8501, Japan.
authors.forename: Ryuichi
authors.initials: R
authors.lastname: Iwakiri
authors.affiliation: Department of Gastroenterology, Osaka City University Graduate School of Medicine, 1-5-7 Asahi-cho, Abeno-ku, Osaka 545-8586, Japan.
authors.forename: Toshio
authors.initials: T
authors.lastname: Watanabe
authors.affiliation: Second Department of Internal Medicine, Osaka Medical College, 2-7 Daigaku-cho, Takatsuki, Osaka 569-8686, Japan.
authors.forename: Toshihisa
authors.initials: T
authors.lastname: Takeuchi
authors.affiliation: Clinical Development, Japan/Asia Clinical Research Product Creation Unit, Eisai Product Creation Systems, Eisai Co., Ltd., 4-6-10 Koishikawa, Bunkyo-ku, Tokyo 112-8088, Japan.
authors.forename: Nobuyuki
authors.initials: N
authors.lastname: Sugisaki
authors.affiliation: Clinical Research Institute and Cerebrovascular Medicine, National Hospital Organization, Kyushu Medical Center, 1-8-1 Jigyohama, Chuo-ku, Fukuoka 810-8563, Japan.
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Okada
authors.affiliation: Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University, 1-1-1 Honjo, Chuo-ku, Kumamoto 860-8556, Japan ; National Cerebral and Cardiovascular Center, 5-7-1 Fujishiro-dai, Suita, Osaka, 565-8565, Japan.
authors.forename: Hisao
authors.initials: H
authors.lastname: Ogawa
authors.affiliation: Department of Gastroenterology, Osaka City University Graduate School of Medicine, 1-5-7 Asahi-cho, Abeno-ku, Osaka 545-8586, Japan.
authors.forename: Tetsuo
authors.initials: T
authors.lastname: Arakawa
authors.affiliation: Department of Internal Medicine, Saga Medical School, 5-1-1 Nabeshima, Saga 849-8501, Japan.
authors.forename: Kazuma
authors.initials: K
authors.lastname: Fujimoto
keywords: bleeding ulcer; low-dose aspirin; peptic ulcer; rabeprazole; serious adverse events