Comparative study of esomeprazole and lansoprazole in triple therapy for eradication of Helicobacter pylori in Japan.
OBJECTIVE
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.


CONCLUSIONS
Esomeprazole showed non-inferiority and safety in a 7 day-triple therapy for eradication of H. pylori compared with lansoprazole.
Tsutomu Nishida, Masahiko Tsujii, Hideki Iijima, Tetsuo Takehara, Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Suita, Osaka 565-0871, Japan.
Tsutomu
T
Nishida
Tsutomu Nishida, Masahiko Tsujii, Hideki Iijima, Tetsuo Takehara, Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Suita, Osaka 565-0871, Japan.
Masahiko
M
Tsujii
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
H
Tanimura
Tsutomu Nishida, Masahiko Tsujii, Hideki Iijima, Tetsuo Takehara, Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Suita, Osaka 565-0871, Japan.
Shusaku
S
Tsutsui
Tsutomu Nishida, Masahiko Tsujii, Hideki Iijima, Tetsuo Takehara, Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Suita, Osaka 565-0871, Japan.
Shingo
S
Tsuji
Tsutomu Nishida, Masahiko Tsujii, Hideki Iijima, Tetsuo Takehara, Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Suita, Osaka 565-0871, Japan.
Akira
A
Takeda
Tsutomu Nishida, Masahiko Tsujii, Hideki Iijima, Tetsuo Takehara, Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Suita, Osaka 565-0871, Japan.
Atsuo
A
Inoue
Tsutomu Nishida, Masahiko Tsujii, Hideki Iijima, Tetsuo Takehara, Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Suita, Osaka 565-0871, Japan.
Hiroyuki
H
Fukui
Tsutomu Nishida, Masahiko Tsujii, Hideki Iijima, Tetsuo Takehara, Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Suita, Osaka 565-0871, Japan.
Toshiyuki
T
Yoshio
Tsutomu Nishida, Masahiko Tsujii, Hideki Iijima, Tetsuo Takehara, Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Suita, Osaka 565-0871, Japan.
Osamu
O
Kishida
Tsutomu Nishida, Masahiko Tsujii, Hideki Iijima, Tetsuo Takehara, Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Suita, Osaka 565-0871, Japan.
Hiroyuki
H
Ogawa
Tsutomu Nishida, Masahiko Tsujii, Hideki Iijima, Tetsuo Takehara, Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Suita, Osaka 565-0871, Japan.
Masahide
M
Oshita
Tsutomu Nishida, Masahiko Tsujii, Hideki Iijima, Tetsuo Takehara, Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Suita, Osaka 565-0871, Japan.
Ichizo
I
Kobayashi
Tsutomu Nishida, Masahiko Tsujii, Hideki Iijima, Tetsuo Takehara, Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Suita, Osaka 565-0871, Japan.
Shinichiro
S
Zushi
Tsutomu Nishida, Masahiko Tsujii, Hideki Iijima, Tetsuo Takehara, Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Suita, Osaka 565-0871, Japan.
Makoto
M
Ichiba
Tsutomu Nishida, Masahiko Tsujii, Hideki Iijima, Tetsuo Takehara, Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Suita, Osaka 565-0871, Japan.
Naoto
N
Uenoyama
Tsutomu Nishida, Masahiko Tsujii, Hideki Iijima, Tetsuo Takehara, Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Suita, Osaka 565-0871, Japan.
Yuichi
Y
Yasunaga
Tsutomu Nishida, Masahiko Tsujii, Hideki Iijima, Tetsuo Takehara, Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Suita, Osaka 565-0871, Japan.
Ryu
R
Ishihara
Tsutomu Nishida, Masahiko Tsujii, Hideki Iijima, Tetsuo Takehara, Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Suita, Osaka 565-0871, Japan.
Mamoru
M
Yura
Tsutomu Nishida, Masahiko Tsujii, Hideki Iijima, Tetsuo Takehara, Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Suita, Osaka 565-0871, Japan.
Masato
M
Komori
Tsutomu Nishida, Masahiko Tsujii, Hideki Iijima, Tetsuo Takehara, Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Suita, Osaka 565-0871, Japan.
Satoshi
S
Egawa
Tsutomu Nishida, Masahiko Tsujii, Hideki Iijima, Tetsuo Takehara, Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Suita, Osaka 565-0871, Japan.
Hideki
H
Iijima
Tsutomu Nishida, Masahiko Tsujii, Hideki Iijima, Tetsuo Takehara, Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, Suita, Osaka 565-0871, Japan.
Tetsuo
T
Takehara
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000897:Anti-Ulcer Agents / Q000008:administration & dosage; D017291:Clarithromycin / Q000494:pharmacology; D004334:Drug Administration Schedule; D024881:Drug Resistance, Bacterial; D004359:Drug Therapy, Combination / Q000379:methods*; D064098:Esomeprazole / Q000008:administration & dosage*; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy*; D006801:Humans; D007564:Japan; D064747:Lansoprazole / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D013997:Time Factors; D055815:Young Adult
D000897:Anti-Ulcer Agents; D064747:Lansoprazole; D017291:Clarithromycin; D064098:Esomeprazole
Eradication; Esomeprazole; Helicobacter pylori; Lansoprazole; Proton pomp inhibitor