Efficacy of Levofloxacin and Rifaximin based Quadruple Therapy in Helicobacter pylori Associated Gastroduodenal Disease: A Double-Blind, Randomized Controlled Trial.
10.3346/jkms.2011.26.6.785
- Author:
Kang Hyun CHOI
1
;
Woo Chul CHUNG
;
Kang Moon LEE
;
Chang Nyol PAIK
;
Eun Jung KIM
;
Bong Koo KANG
;
Ju Hyun OAK
;
Sung Hoon JUNG
Author Information
1. Department of Internal Medicine, St. Vincent Hospital, College of Medicine, The Catholic University of Korea, Suwon, Korea. jwchulkr@catholic.ac.kr
- Publication Type:Original Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
- Keywords:
Helicobacter pylori;
Anti-Bacterial Agents;
Rifaximin
- MeSH:
Adult;
Aged;
Amoxicillin/administration & dosage;
Anti-Bacterial Agents/*administration & dosage;
Clarithromycin/administration & dosage;
Diarrhea/chemically induced;
Double-Blind Method;
Drug Therapy, Combination;
Female;
Helicobacter Infections/complications/*drug therapy;
*Helicobacter pylori;
Humans;
Male;
Middle Aged;
Ofloxacin/*administration & dosage;
Omeprazole/administration & dosage;
Peptic Ulcer/complications/*drug therapy;
Prospective Studies;
Rifamycins/*administration & dosage
- From:Journal of Korean Medical Science
2011;26(6):785-790
- CountryRepublic of Korea
- Language:English
-
Abstract:
The aim of this study was to evaluate the efficacy of levofloxacin and rifaximin based quadruple regimen as first-line treatment for Helicobacter pylori infection. A prospectively randomized, double-blinded, parallel group, comparative study was performed. Three hundred consecutive H. pylori positive patients were randomized to receive: omeprazole, amoxicillin, clarithromycin (OAC); omeprazole, amoxicillin, levofloxacin (OAL); and omeprazole, amoxicillin, levofloxacin, rifaximin (OAL-R). The eradication rates in the intention to treat (ITT) and per protocol (PP) analyses were: OAC, 77.8% and 85.6%; OAL, 65.3% and 73.6%; and OAL-R, 74.5% and 80.2%. The eradication rate achieved with OAC was higher than with OAL on the ITT (P = 0.05) and PP analysis (P = 0.04). OAL-R regimen was not inferior to OAC. The frequency of moderate to severe adverse effects was significantly higher in OAC treatment group. Especially, diarrhea was most common complaint, and there was a significantly low rate of moderate to severe diarrhea with the rifaximin containing regimen. In conclusion, the levofloxacin and rifaximin based regimen comes up to the standard triple therapy, but has a limited efficacy in a Korean cohort. The rifaximin containing regimen has a very high safety profile for H. pylori eradication therapy.
