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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

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...

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Autores principales: Fujishiro, Mitsuhiro, Higuchi, Kazuhide, Kato, Mototsugu, Kinoshita, Yoshikazu, Iwakiri, Ryuichi, Watanabe, Toshio, Takeuchi, Toshihisa, Sugisaki, Nobuyuki, Okada, Yasushi, Ogawa, Hisao, Arakawa, Tetsuo, Fujimoto, Kazuma
Formato: Online Artículo Texto
Lenguaje:English
Publicado: the Society for Free Radical Research Japan 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4454079/
https://www.ncbi.nlm.nih.gov/pubmed/26060354
http://dx.doi.org/10.3164/jcbn.15-1
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author Fujishiro, Mitsuhiro
Higuchi, Kazuhide
Kato, Mototsugu
Kinoshita, Yoshikazu
Iwakiri, Ryuichi
Watanabe, Toshio
Takeuchi, Toshihisa
Sugisaki, Nobuyuki
Okada, Yasushi
Ogawa, Hisao
Arakawa, Tetsuo
Fujimoto, Kazuma
author_facet Fujishiro, Mitsuhiro
Higuchi, Kazuhide
Kato, Mototsugu
Kinoshita, Yoshikazu
Iwakiri, Ryuichi
Watanabe, Toshio
Takeuchi, Toshihisa
Sugisaki, Nobuyuki
Okada, Yasushi
Ogawa, Hisao
Arakawa, Tetsuo
Fujimoto, Kazuma
author_sort Fujishiro, Mitsuhiro
collection PubMed
description 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.
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spelling pubmed-44540792015-07-01 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 Fujishiro, Mitsuhiro Higuchi, Kazuhide Kato, Mototsugu Kinoshita, Yoshikazu Iwakiri, Ryuichi Watanabe, Toshio Takeuchi, Toshihisa Sugisaki, Nobuyuki Okada, Yasushi Ogawa, Hisao Arakawa, Tetsuo Fujimoto, Kazuma J Clin Biochem Nutr Original Article 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. the Society for Free Radical Research Japan 2015-05 2015-04-08 /pmc/articles/PMC4454079/ /pubmed/26060354 http://dx.doi.org/10.3164/jcbn.15-1 Text en Copyright © 2015 JCBN This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Original Article
Fujishiro, Mitsuhiro
Higuchi, Kazuhide
Kato, Mototsugu
Kinoshita, Yoshikazu
Iwakiri, Ryuichi
Watanabe, Toshio
Takeuchi, Toshihisa
Sugisaki, Nobuyuki
Okada, Yasushi
Ogawa, Hisao
Arakawa, Tetsuo
Fujimoto, Kazuma
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
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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4454079/
https://www.ncbi.nlm.nih.gov/pubmed/26060354
http://dx.doi.org/10.3164/jcbn.15-1
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