Authors: Kiyoshi Ashida Yoshikazu Kinoshita Michio Hongo The Japan Rabeprazole Study Group for NERD
Publish Date: 2011/02/08
Volume: 56, Issue: 8, Pages: 2333-2342
Abstract
Subjects were grade M minimal changes NERD patients Twentytwo patients not responding to open label antacid therapy entered a doubleblind treatment phase in which rabeprazole 5 mg or 10 mg/day for four weeks were compared Twentyfourhour esophageal pH monitoring was performed before and on treatment at week 4 to assess the pharmacodynamic effect of these doses of rabeprazoleThe frequency of heartburn episodes and the number of acid reflux episodes in the esophagus corresponded well in grade M NERD patients r = 044 P = 0042 Median percentage of time at pH 4 was 43 before treatment and 11 on treatment with rabeprazole 5 mg change from baseline −25 whereas the median percentage of time at pH 4 in the rabeprazole 10 mg group was 74 before treatment and 05 on treatment change from baseline −66 Likewise treatmentrelated changes of median number of reflux episodes were −180 with rabeprazole 5 mg and −440 with rabeprazole 10 mg For each esophageal pH data no significant differences were observed between the two groups P = 0377 P = 0077Administration of 5 mg and 10 mg rabeprazole sufficiently inhibited pathological gastroesophageal acid reflux and relieved heartburn episodes in NERD patients who did not respond to an antacid Further investigation would be necessary to determine proper usage of the two dosesValuable advice was given by Suminobu Ito MD PhD National Hospital Organization Tokyo Japan regarding the plan and operation of this clinical trial The authors also wish to thank the sponsor Clinical Research Center of Eisai Co Ltd Tokyo Japan and the project members of Acronet Corp Ltd Tokyo Japan for their contribution in the study monitoring This study was funded by Eisai Co Ltd Tokyo Japan The writing and preparation of this paper were funded in part by Clinical Research Center of Eisai Co Ltd Tokyo Japan Writing support was provided by Eisai Global Clinical Woodcliff Lake NJ USA Data analysis was undertaken by the Clinical Research Center of Eisai Co Ltd Tokyo JapanKiyoshi Ashida MD PhD has served as a consultant for Eisai Co Ltd AstraZeneca Japan and Takeda Pharmaceutical Co Ltd Yoshikazu Kinoshita MD PhD has served as a consultant for Eisai Co Ltd Astellas Pharma Inc AstraZeneca Pharmaceuticals Taiho and Takeda Pharmaceutical Company Ltd Michio Hongo MD PhD has served as a consultant for Eisai Co Ltd Abbott Japan Co Ltd Astellas Pharma Inc AstraZeneca Japan Asubio Pharma Co Ltd DainipponSumitomo Pharma Co Ltd Kyowa Hakko Co Ltd Sucampo Pharmaceuticals Inc Takeda Pharmaceutical Co Ltd and Zeria Pharmaceutical Co LtdKatsuhiko Iwakiri from Nippon Medical School Hospital Tokyo Japan Naomi Uemura and Junichi Akiyama from International Medical Center of Japan Tokyo Japan Takashi Joh Makoto Sasaki Hiromi Kataoka Tsuneya Wada Satoshi Tanida and Tadayuki Oshima from Nagoya City University Graduate School of Medical Sciences Nagoya Japan Yoshihide Fujiyama from Shiga University of Medical Science Otsu Japan Yasuhiro Fujiwara from Osaka City University Graduate School of Medicine Osaka Japan Kiyoshi Ashida from Saiseikai Nakatsu Hospital Osaka Japan Kyoichi Adachi Kenji Furuta Masaharu Miki and Takane Azumi from Shimane University Faculty of Medicine Izumo Japan Tomohiko Shimatani and Masaki Inoue from Department of General Medicine Hiroshima University Hospital Hiroshima Japan Shinji Tanaka Noriaki Manabe Yoshitaka Ueno Shigeto Yoshida Toru Hiyama Shiro Oka and Masanori Ito from Department of Endoscopy Hiroshima University Hospital Hiroshima Japan Tomoharu Yoshida and Shomei Ryozawa from Yamaguchi University Graduate School of Medicine Ube Japan Nobuo Yurino and Yasunori Kyoyama from ShinYukuhashi Hospital Yukuhashi Japan Teppei Kabemura Toshiaki Ochiai and Daisuke Yoshimura from Saiseikai Fukuoka General Hospital Fukuoka Japan Takahiro Itoyama and Keizo Omori from Fukuoka Wajiro Hospital Fukuoka Japan Kazuma Fujimoto and Hiroyuki Sakata from Saga Medical School Saga Japan
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