Research Report
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World J Gastroenterol. Apr 21, 2014; 20(15): 4362-4369
Published online Apr 21, 2014. doi: 10.3748/wjg.v20.i15.4362
Comparative study of esomeprazole and lansoprazole in triple therapy for eradication of Helicobacter pylori in Japan
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
Tsutomu Nishida, Masahiko Tsujii, Hideki Iijima, Tetsuo Takehara, Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Suita, Osaka 565-0871, Japan
Hirohisa Tanimura, Department of Gastroenterology, Osaka Kaisei Hospital, Osaka 532-0003, Japan
Shusaku Tsutsui, Department of Gastroenterology, Itami City Hospital, Itami 664-8540, Japan
Shingo Tsuji, Department of Gastroenterology, Osaka Seamen’s Insurance Hospital, Osaka 552-0021, Japan
Akira Takeda, Department of Gastroenterology, Ashiya Municipal Hospital, Ashiya 659-8502, Japan
Atsuo Inoue, Department of Gastroenterology, Osaka General Medical Center, Osaka 558-8558, Japan
Hiroyuki Fukui, Department of Gastroenterology, Yao Municipal Hospital, Yao 581-0069, Japan
Toshiyuki Yoshio, Department of Gastroenterology, Osaka National Hospital, Osaka 540-0006, Japan
Osamu Kishida, Department of Gastroenterology, Sumitomo Hospital, Osaka 565-0871, Japan
Hiroyuki Ogawa, Department of Gastroenterology, Nishinomiya Municipal Central Hospital, Nishinomiya 663-8014, Japan
Masahide Oshita, Department of Internal Medicine, Osaka Police Hospital, Osaka 543-0035, Japan
Ichizo Kobayashi, Department of Gastroenterology, Higashiosaka City General Hospital, Higashiosaka 578- 8588, Japan
Shinichiro Zushi, Department of Gastroenterology, Ikeda Municipal Hospital, Ikeda 563-0025, Japan
Makoto Ichiba, Department of Gastroenterology, Toyonaka Municipal Hospital, Toyonaka 560-0055, Japan
Naoto Uenoyama, Department of Gastroenterology, Otemae Hospital, Osaka 540-0008, Japan
Yuichi Yasunaga, Department of Gastroenterology, Hyogo Prefectural Nishinomiya Hospital, Nishinomiya 662-0918, Japan
Ryu Ishihara, Department of Gastrointestinal Oncology, Osaka Medical Center for Cancer and Cardiovascular Disease, Osaka 537-0025, Japan
Mamoru Yura, Department of Gastroenterology, Minoh City Hospital, Minoh 562-0014, Japan
Masato Komori, Department of Gastroenterology, Osaka Rosai Hospital, Sakai 591-8025, Japan
Satoshi Egawa, Department of Gastroenterology, Kansai Rosai Hospital, Amagasaki 660-8511, Japan
Author contributions: Nishida T wrote the manuscript; Nishida T, Tsujii M and Tsuji S concept and designed this study; Nishida T, Tsujii M, Tanimura H, Tsutsui S, Tsuji S, Takeda A, Inoue A, Fukui H, Yoshio T, Kishida O, Ogawa H, Oshita M, Kobayashi I, Zushi S, Ichiba M, Uenoyama N, Yasunaga Y, Ishihara R, Yura M, Komori M, Egawa S and Iijima H collected the data; Takehara T provided scientific editing and assisted with writing the manuscript.
Correspondence to: Tetsuo Takehara, MD, PhD, Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan. takehara@gh.med.osaka-u.ac.jp
Telephone: +81-6-68793621  Fax: +81-6-68793629
Received: November 19, 2013
Revised: December 31, 2013
Accepted: January 20, 2014
Published online: April 21, 2014
Processing time: 148 Days and 19 Hours
Abstract

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.

Keywords: Helicobacter pylori; Eradication; Esomeprazole; Lansoprazole; Proton pomp inhibitor

Core tip: Amoxicillin is a standard regime for Helicobacter pylori (H. pylori) eradication in Japan. Esomeprazole is a second-generation PPI that became available in 2011 in Japan. Several studies have reported eradication data comparing esomeprazole to first-generation proton pump inhibitors (PPIs), but it is not known whether the H. pylori eradication rates of esomeprazole are equal to those of lansoprazole, a first-generation PPI, under circumstances of increased resistance to clarithromycin in Japan.