Retrospective Study
Copyright ©The Author(s) 2015. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. May 14, 2015; 21(18): 5568-5574
Published online May 14, 2015. doi: 10.3748/wjg.v21.i18.5568
Efficacy of 14-d vs 7-d moxifloxacin-based triple regimens for second-line Helicobacter pylori eradication
Jae Jin Hwang, Dong Ho Lee, Ae-Ra Lee, Hyuk Yoon, Cheol Min Shin, Young Soo Park, Nayoung Kim
Jae Jin Hwang, Dong Ho Lee, Ae-Ra Lee, Hyuk Yoon, Cheol Min Shin, Young Soo Park, Nayoung Kim, Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Gyeonggi-do 463-707, South Korea
Author contributions: Hwang JJ and Lee DH were responsible for the study conception and design, data analysis and interpretation, and manuscript drafting; Lee AR, Yoon H, Shin CM, Park YS and Kim N critically revised the article for important intellectual content; all the authors reviewed and approved the final version to be published.
Ethics approval: The study was reviewed and approved by the Seoul National University Bundang Hospital Institutional Review Board.
Conflict-of-interest: No potential conflicts of interest relevant to this article were reported.
Data sharing: No additional data are available.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Dong Ho Lee, MD, Department of Internal Medicine, Seoul National University Bundang Hospital, 82, Gumi-ro 173 beon-gil, Bundang-gu, Seongnam, Gyeonggi-do 463-707, South Korea. dhljohn@yahoo.co.kr
Telephone: +82-31-7877006 Fax: +82-31-7874051
Received: November 19, 2014
Peer-review started: November 19, 2014
First decision: December 11, 2014
Revised: January 2, 2015
Accepted: February 11, 2015
Article in press: February 11, 2015
Published online: May 14, 2015
Processing time: 180 Days and 10.3 Hours
Abstract

AIM: To evaluate the efficacy of the 14-d moxifloxacin-based triple therapy for the second-line eradication of Helicobacter pylori (H. pylori) infection.

METHODS: Between 2011 and 2013, we conducted a retrospective review of the medical records of 160 patients who had experienced failure of their first-line proton pump inhibitor-based eradication therapy and subsequently received the moxifloxacin-based triple therapy as a second-line eradication treatment regimen. The patients who were treated with the moxifloxacin-based triple therapy (oral 20 mg rabeprazole b.i.d., 1000 mg amoxicillin b.i.d., and 400 mg moxifloxacin q.d.) for 7 d were assigned to the RAM-7 group (n = 79) while those who took them for 14 days were assigned to RAM-14 group (n = 81). The eradication rates for both groups were determined by intention-to-treat (ITT) and per-protocol (PP) analyses. ITT analysis compared the treatment groups as originally allocated while the PP analysis including only those patients who had completed the treatment as originally allocated. Successful eradication therapy for H. pylori infection was defined as the documentation of a negative 13C-urea breath test 4 wk after the end of the eradication treatment.

RESULTS: The overall ITT eradication rate was 76.2% (122/160). The final ITT eradication rates were 70.8% (56/79; 95%CI: 63.3%-77.1%) in the RAM-7 group and 81.4% (66/81; 95%CI: 74.6%-88.3%) in the RAM-14 group (P = 0.034). The overall PP eradication rate was 84.1% (122/145), and the final PP eradication rates were 77.7% (56/72; 95%CI: 70.2%-85.3%) in the RAM-7 group and 90.4% (66/73; 95%CI: 82.8%-98.1%) in the RAM-14 group (P = 0.017). The H. pylori-eradication rates in the RAM-14 group were significantly higher compared with that of the RAM-7 group according to both the ITT (P = 0.034) and the PP analyses (P = 0.017). Both groups exhibited good treatment compliance (RAM-7/RAM-14 group: 100%/100%). The adverse event rates were 19.4% (14/72) and 20.5% (15/73) in the RAM-7 and RAM-14 groups, respectively (P = 0.441). Adverse events occurred in 14 of the 72 patients (19.4) in the RAM-7 group and in 15 of the 73 patients (20.5) in the RAM-14 group. No statistically significant differences (P = 0.441) were observed.

CONCLUSION: The 14-d moxifloxacin-based triple therapy is a significantly more effective second-line eradication treatment as compared to the 7-d alternative for H. pylori infection in South Korea.

Keywords: Helicobacter pylori; Treatment failure; Second-line treatment; Moxifloxacin; Eradication rate

Core tip: This study aimed to evaluate the efficacy of the 14-d moxifloxacin-based triple therapy compared to the corresponding 7-d regimen for second-line Helicobacter pylori (H. pylori) eradication in South Korea. The H. pylori-eradication rates in the RAM-14 group were significantly higher compared to the RAM-7 group for both the intention-to-treat and per-protocol analysis. The high eradication rate, excellent compliance, and safety of the 14-d regimen suggest its potential suitability as an alternative to the standard bismuth-based quadruple therapy. The 14-d moxifloxacin-based triple therapy is a significantly more effective second-line eradication treatment than the 7-d alternative for H. pylori infection in Korean patients.