Comparative study of esomeprazole and lansoprazole in triple therapy for eradication ofHelicobacter pyloriin Japan

Autor: Yuichi Yasunaga, Shinichiro Zushi, Toshiyuki Yoshio, Masato Komori, Tsutomu Nishida, Ryu Ishihara, Ichizo Kobayashi, Satoshi Egawa, Naoto Uenoyama, Osamu Kishida, Atsuo Inoue, Makoto Ichiba, Hiroyuki Ogawa, Hirohisa Tanimura, Masahide Oshita, Shusaku Tsutsui, Hideki Iijima, Hiroyuki Fukui, Shingo Tsuji, Mamoru Yura, Masahiko Tsujii, Tetsuo Takehara, Akira Takeda
Rok vydání: 2014
Předmět:
Zdroj: World Journal of Gastroenterology. 20:4362
ISSN: 1007-9327
Popis: 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.
Databáze: OpenAIRE