Document Detail

Comparative study of esomeprazole and lansoprazole in triple therapy for eradication of Helicobacter pylori in Japan.
MedLine Citation:
PMID:  24764674     Owner:  NLM     Status:  In-Data-Review    
AIM: To evaluate the efficacy and safety of esomeprazole-based triple therapy compared with lansoprazole therapy as first-line eradication therapy for patients with Helicobacter pylori (H. pylori) in usual post-marketing use in Japan, where the clarithromycin (CAM) resistance rate is 30%.
METHODS: For this multicenter, randomized, open-label, non-inferiority trial, we recruited patients (≥ 20 years of age) with H. pylori infection from 20 hospitals in Japan. We randomly allocated patients to esomeprazole therapy (esomeprazole 20 mg, CAM 400 mg, amoxicillin (AC) 750 mg for the first 7 d, with all drugs given twice daily) or lansoprazole therapy (lansoprazole 30 mg, CAM 400 mg, AC 750 mg for the first 7 d, with all drugs given twice daily) using a minimization method with age, sex, and institution as adjustment factors. Our primary outcome was the eradication rate by intention-to-treat (ITT) and per-protocol (PP) analyses. H. pylori eradication was confirmed by a urea breath test from 4 to 8 wk after cessation of therapy.
RESULTS: ITT analysis revealed the eradication rates of 69.4% (95%CI: 61.2%-76.6%) for esomeprazole therapy and 73.9% (95%CI: 65.9%-80.6%) for lansoprazole therapy (P = 0.4982). PP analysis showed eradication rate of 76.9% (95%CI: 68.6%-83.5%) for esomeprazole therapy and 79.8% (95%CI: 71.9%-86.0%) for lansoprazole therapy (P = 0.6423). There were no differences in adverse effects between the two therapies.
CONCLUSION: Esomeprazole showed non-inferiority and safety in a 7 day-triple therapy for eradication of H. pylori compared with lansoprazole.
Tsutomu Nishida; Masahiko Tsujii; Hirohisa Tanimura; Shusaku Tsutsui; Shingo Tsuji; Akira Takeda; Atsuo Inoue; Hiroyuki Fukui; Toshiyuki Yoshio; Osamu Kishida; Hiroyuki Ogawa; Masahide Oshita; Ichizo Kobayashi; Shinichiro Zushi; Makoto Ichiba; Naoto Uenoyama; Yuichi Yasunaga; Ryu Ishihara; Mamoru Yura; Masato Komori; Satoshi Egawa; Hideki Iijima; Tetsuo Takehara
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  World journal of gastroenterology : WJG     Volume:  20     ISSN:  1007-9327     ISO Abbreviation:  World J. Gastroenterol.     Publication Date:  2014 Apr 
Date Detail:
Created Date:  2014-04-25     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  100883448     Medline TA:  World J Gastroenterol     Country:  China    
Other Details:
Languages:  eng     Pagination:  4362-9     Citation Subset:  IM    
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