caa a22 4500 445887877 CHVBK 20180317145605.0 cr unu---uuuuu 170323e20110601xx s 000 0 eng 10.1007/s00535-011-0397-7 doi (NATIONALLICENCE)springer-10.1007/s00535-011-0397-7 Lansoprazole for secondary prevention of gastric or duodenal ulcers associated with long-term low-dose aspirin therapy: results of a prospective, multicenter, double-blind, randomized, double-dummy, active-controlled trial [Elektronische Daten] [Kentaro Sugano, Yasushi Matsumoto, Tsukasa Itabashi, Sumihisa Abe, Nobuhiro Sakaki, Kiyoshi Ashida, Yuji Mizokami, Tsutomu Chiba, Shigeyuki Matsui, Tatsuya Kanto, Kazuyuki Shimada, Shinichiro Uchiyama, Naomi Uemura, Naoki Hiramatsu] Background: The efficacy of low-dose lansoprazole has not been established for the prevention of recurrent gastric or duodenal ulcers in those receiving long-term low-dose aspirin (LDA) for cardiovascular and cerebrovascular protection. This study sought to examine the efficacy of low-dose lansoprazole (15mg once daily) for the secondary prevention of LDA-associated gastric or duodenal ulcers. Methods: Patients were randomized to receive lansoprazole 15mg daily (n=226) or gefarnate 50mg twice daily (n=235) for 12months or longer in a prospective, multicenter, double-blind, randomized active-controlled trial, followed by a 6-month follow-up study with open-label lansoprazole treatment. The study utilized 94 sites in Japan and 461 Japanese patients with a history of gastric or duodenal ulcers who required long-term LDA therapy for cardiovascular and cerebrovascular disease. Results: The primary endpoint was the development of gastric or duodenal ulcers. The cumulative incidence of gastric or duodenal ulcers on days 91, 181, and 361 from the start of the study was calculated by the Kaplan-Meier method as 1.5, 2.1, and 3.7%, respectively, in the lansoprazole group versus 15.2, 24.0, and 31.7%, respectively, in the gefarnate group. The risk of ulcer development was significantly (log-rank test, P<0.001) lower in the lansoprazole group than in the gefarnate group, with the hazard ratio being 0.099 (95% confidence interval [CI] 0.042-0.230). Conclusion: Lansoprazole was superior to gefarnate in reducing the risk of gastric or duodenal ulcer recurrence in patients with a definite history of gastric or duodenal ulcers who required long-term LDA therapy. (c) Author(s), 2011 Low-dose aspirin nationallicence Gastric or duodenal ulcers nationallicence Lansoprazole nationallicence Cardiovascular diseases nationallicence Cerebrovascular diseases nationallicence Sugano Kentaro Division of Gastroenterology, Department of Internal Medicine, Jichi Medical University, 3311-1 Yakushiji, 329-0498, Shimotsuke, Tochigi, Japan aut Matsumoto Yasushi Department of Neuroendovascular Therapy, Kohnan Hospital, Nagamachi-Minami, Taihaku-ku, 982-8523, Sendai, Miyagi, Japan aut Itabashi Tsukasa Hokusetsu General Hospital, 6-24 Kita-Yanagawacho, 569-0000, Takatsuki, Osaka, Japan aut Abe Sumihisa Koukan Clinic, 1-2-1 Koukan Dori, Kawasaki-ku, 210-0852, Kawasaki, Kanagawa, Japan aut Sakaki Nobuhiro Ebara Hospital, Tokyo Metropolitan Health and Medical Treatment Corporation, 4-5-10 Higashi-Yukigaya, Ota-ku, 145-0065, Tokyo, Japan aut Ashida Kiyoshi Department of Gastroenterology, Osaka Saiseikai Nakatsu Hospital, 2-10-39 Shibata, Kita-ku, 530-0012, Osaka, Japan aut Mizokami Yuji Department of Gastroenterology, Tsukuba University Hospital, 2-1-1 Amakubo, 305-8567, Tsukuba, Ibaraki, Japan aut Chiba Tsutomu Department of Gastroenterology and Hepatology, Graduate School of Medicine, Kyoto University, Yoshida-Konoecho, Sakyo-ku, 606-8501, Kyoto, Japan aut Matsui Shigeyuki Department of Data Science, The Institute of Statistical Mathematics, 10-3 Midorimachi, 190-8562, Tachikawa, Tokyo, Japan aut Kanto Tatsuya Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Yamadaoka, 565-0871, Suita, Osaka, Japan aut Shimada Kazuyuki Division of Cardiovascular Medicine, Department of Internal Medicine, Jichi Medical University Hospital, 3311-1 Yakushiji, 329-0498, Shimotsuke, Tochigi, Japan aut Uchiyama Shinichiro Department of Neurology, Tokyo Women's Medical University, Kawada-cho, Shinjuku-ku, 162-8666, Tokyo, Japan aut Uemura Naomi Department of Gastroenterology, Kohnodai Hospital, National Center for Global Health and Medicine, Kohnodai, 272-8516, Ichikawa, Chiba, Japan aut Hiramatsu Naoki Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Yamadaoka, 565-0871, Suita, Osaka, Japan aut Journal of Gastroenterology Springer Japan 46/6(2011-06-01), 724-735 0944-1174 46:6<724 2011 46 535 https://doi.org/10.1007/s00535-011-0397-7 text/html Onlinezugriff via DOI 1 research-article jats NATIONALLICENCE 856 40 https://doi.org/10.1007/s00535-011-0397-7 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Sugano Kentaro Division of Gastroenterology, Department of Internal Medicine, Jichi Medical University, 3311-1 Yakushiji, 329-0498, Shimotsuke, Tochigi, Japan aut NATIONALLICENCE 700 1- Matsumoto Yasushi Department of Neuroendovascular Therapy, Kohnan Hospital, Nagamachi-Minami, Taihaku-ku, 982-8523, Sendai, Miyagi, Japan aut NATIONALLICENCE 700 1- Itabashi Tsukasa Hokusetsu General Hospital, 6-24 Kita-Yanagawacho, 569-0000, Takatsuki, Osaka, Japan aut NATIONALLICENCE 700 1- Abe Sumihisa Koukan Clinic, 1-2-1 Koukan Dori, Kawasaki-ku, 210-0852, Kawasaki, Kanagawa, Japan aut NATIONALLICENCE 700 1- Sakaki Nobuhiro Ebara Hospital, Tokyo Metropolitan Health and Medical Treatment Corporation, 4-5-10 Higashi-Yukigaya, Ota-ku, 145-0065, Tokyo, Japan aut NATIONALLICENCE 700 1- Ashida Kiyoshi Department of Gastroenterology, Osaka Saiseikai Nakatsu Hospital, 2-10-39 Shibata, Kita-ku, 530-0012, Osaka, Japan aut NATIONALLICENCE 700 1- Mizokami Yuji Department of Gastroenterology, Tsukuba University Hospital, 2-1-1 Amakubo, 305-8567, Tsukuba, Ibaraki, Japan aut NATIONALLICENCE 700 1- Chiba Tsutomu Department of Gastroenterology and Hepatology, Graduate School of Medicine, Kyoto University, Yoshida-Konoecho, Sakyo-ku, 606-8501, Kyoto, Japan aut NATIONALLICENCE 700 1- Matsui Shigeyuki Department of Data Science, The Institute of Statistical Mathematics, 10-3 Midorimachi, 190-8562, Tachikawa, Tokyo, Japan aut NATIONALLICENCE 700 1- Kanto Tatsuya Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Yamadaoka, 565-0871, Suita, Osaka, Japan aut NATIONALLICENCE 700 1- Shimada Kazuyuki Division of Cardiovascular Medicine, Department of Internal Medicine, Jichi Medical University Hospital, 3311-1 Yakushiji, 329-0498, Shimotsuke, Tochigi, Japan aut NATIONALLICENCE 700 1- Uchiyama Shinichiro Department of Neurology, Tokyo Women's Medical University, Kawada-cho, Shinjuku-ku, 162-8666, Tokyo, Japan aut NATIONALLICENCE 700 1- Uemura Naomi Department of Gastroenterology, Kohnodai Hospital, National Center for Global Health and Medicine, Kohnodai, 272-8516, Ichikawa, Chiba, Japan aut NATIONALLICENCE 700 1- Hiramatsu Naoki Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Yamadaoka, 565-0871, Suita, Osaka, Japan aut NATIONALLICENCE 773 0- Journal of Gastroenterology Springer Japan 46/6(2011-06-01), 724-735 0944-1174 46:6<724 2011 46 535 Metadata rights 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