Document Detail


Safety and efficacy of long-term maintenance therapy with oral dose of rabeprazole 10 mg once daily in Japanese patients with reflux esophagitis.
MedLine Citation:
PMID:  21297318     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVE: The aim of this prospective clinical study was to evaluate the efficacy and safety of long-term proton pump inhibitor (PPI) treatment for two years in Japanese patients with reflux esophagitis (RE).
METHODS: The efficacy and safety of two-year (104-week) treatment with rabeprazole (RPZ) 10 mg were studied in patients confirmed to have been cured of RE by PPI and who required long-term maintenance therapy with PPI. We performed serial endoscopy, checked gastroesophageal reflux disease (GERD) symptoms, adverse events, laboratory values and serum gastrin. We also monitored gastric mucosal histology, atrophy and polyps.
RESULTS: The endoscopic non-relapse rate for RE was 87.3% for the 104-week period. GERD symptoms improved based on the fact that the mean change from baseline in GERD symptom score after treatment was a negative value. Treatment was safe; and atrophy was found to have developed in virtually no cases. A few new benign fundic gland or hyperplastic polyps developed throughout the study, but no ECL carcinoids were found to have developed. Serum gastrin levels tended to increase up to 24 weeks, but there were no subsequent changes thereafter up to 104 weeks.
CONCLUSION: The results confirmed oral RPZ 10 mg to be effective for maintenance therapy in Japanese patients with RE. Although effects on the gastric mucosa were not ruled out, long-term use of RPZ was confirmed to be safe overall.
Authors:
Kazuma Fujimoto; Michio Hongo;
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Publication Detail:
Type:  Clinical Trial; Journal Article     Date:  2011-02-01
Journal Detail:
Title:  Internal medicine (Tokyo, Japan)     Volume:  50     ISSN:  1349-7235     ISO Abbreviation:  Intern. Med.     Publication Date:  2011  
Date Detail:
Created Date:  2011-02-07     Completed Date:  2011-05-19     Revised Date:  2013-04-16    
Medline Journal Info:
Nlm Unique ID:  9204241     Medline TA:  Intern Med     Country:  Japan    
Other Details:
Languages:  eng     Pagination:  179-88     Citation Subset:  IM    
Affiliation:
Department of Internal Medicine, Saga Medical School, Japan. fujimoto@med.saga-u.ac.jp
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MeSH Terms
Descriptor/Qualifier:
2-Pyridinylmethylsulfinylbenzimidazoles / administration & dosage,  adverse effects*,  therapeutic use*
Administration, Oral
Aged
Dose-Response Relationship, Drug
Esophagitis, Peptic / drug therapy*,  ethnology*,  pathology
Female
Gastric Mucosa / pathology
Gastrins / blood
Gastroesophageal Reflux / epidemiology,  ethnology
Humans
Japan / epidemiology
Longitudinal Studies
Male
Middle Aged
Prevalence
Prospective Studies
Proton Pump Inhibitors / administration & dosage,  adverse effects*,  therapeutic use*
Treatment Outcome
Chemical
Reg. No./Substance:
0/2-Pyridinylmethylsulfinylbenzimidazoles; 0/Gastrins; 0/Proton Pump Inhibitors; 32828355LL/rabeprazole
Investigator
Investigator/Affiliation:
Tsuyoshi Yabana / ; Takeaki Kobayashi / ; Masashi Nomura / ; Masafumi Yoshida / ; Shinya Mitsui / ; Akio Katanuma / ; Masafumi Komatsu / ; Akira Zeniya / ; Kazutoshi Fukase / ; Katsuhiro Mabe / ; Chieko Kato / ; Yasukuni Suzuki / ; Yasutoshi Saito / ; Nobuo Toda / ; Susumu Kurosawa / ; Rei Kashima / ; Tetsuo Ebihara / ; Toshihide Maruyama / ; Ryoichi Wada / ; Tokuhisa Sezaki / ; Nobuto Hirata / ; Yasushi Kuyama / ; Taro Ishii / ; Takatsugu Yamamoto / ; Jun Miwa / ; Yasuo Matsubara / ; Nobuyuki Matsuhashi / ; Yukihiro Sakurai / ; Masako Asayama / ; Koji Higa / ; Tomohiko Hasue / ; Hirokazu Komatsu / ; Kiyoko Imamura / ; Shigeru Yamanaka / ; Yoshio Hosaka / ; Yuriko Hara / ; Shuichi Nagakubo / ; Sotaro Fujimoto / ; Hiromu Kutsumi / ; Nobuaki Yagi / ; Masahiro Arai / ; Kenjiro Yasuda / ; Masatoshi Miyata / ; Munehiro Sakata / ; Moose Ueda / ; Mami Ogawa / ; Toshiki Takemura / ; Hideto Inokuchi / ; Masataka Matsushita / ; Kengo Takimoto / ; Hideyuki Shiomi / ; Takama Maekawa / ; Yukimasa Yamashita / ; Toko Kaneshiro / ; Masamichi Nasu / ; Kazuhiko Inoue / ; Osamu Mihara / ; Shiro Okamoto / ; Kanji Kodama / ; Toru Hidaka / ; Akira Tari / ; Hiroshi Tani / ; Tomoki Inaba / ; Masaki Wato / ; Shuji Inoue / ; Sae Kujime / ; Kozo Fuke / ; Masahito Nakauchi / ; Chiaki Watanabe / ; Kazuo Nakajo / ; Yozo Iida / ; Noboru Maetani / ; Ryuichiro Maekawa / ; Shinichi Iwanaga / ; Masaru Sasaki / ; Hajime Aino / ; Kazuma Fujimoto / ; Ryuichi Iwakiri / ; Hiroyuki Sakata / ; Akifumi Ootani /
Comments/Corrections
Comment In:
Intern Med. 2011;50(11):1267; author reply 1269   [PMID:  21776623 ]

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