Elsevier

Digestive and Liver Disease

Volume 42, Issue 2, February 2010, Pages 110-114
Digestive and Liver Disease

Alimentary Tract
Efficacy of four different moxifloxacin-based triple therapies for first-line H. pylori treatment

https://doi.org/10.1016/j.dld.2009.05.013Get rights and content

Abstract

Moxifloxacin has been used in the first-line treatment of Helicobacter pylori infection. The optimal dosage and duration have not been assessed.

Aim

To evaluate the effectiveness of moxifloxacin, amoxicillin and esomeprazole in four regimens, in previously untreated patients infected by H. pylori.

Methods and patients

Patients were randomly assigned to: esomeprazole 20 mg b.i.d., amoxicillin 1 g b.i.d., and one of each of the four following dosages of moxifloxacin: moxifloxacin 400 mg b.i.d. for 10 days (EAM800 × 10), moxifloxacin 400 mg b.i.d. for 7 days (EAM800 × 7), moxifloxacin 400 mg b.i.d. for 5 days (EAM800 × 5), moxifloxacin 400 mg o.i.d. for 10 days (EAM400 × 10). Eradication was assessed by the Urea Breath Test (UBT) 2 months following the end of therapy.

Results

Ninety-four, 102, 92 and 105 patients were recruited in EAM800 × 10, EAM800 × 7, EAM800 × 5, and EAM400 × 10 respectively. The eradication rate was for Intention-To-Treat (ITT) and Per Protocol (PP) analyses: EAM800 × 10 group ITT: 90.4%, PP: 94.4%; EAM800 × 7 group ITT: 80.3%, PP: 86.3%; EAM800 × 5 group ITT: 71.4%, PP: 75.2%; EAM400 × 10 group ITT: 80.0%, PP 84.8%. A statistically significant difference was reached between EAM800 × 10 vs. EAM800 × 7 (ITT and PP: P < 0.05), and between EAM800 × 10 vs. EAM800 × 5 (ITT and PP: P < 0.01) and vs. EAM400 × 10 (ITT: P < 0.05; PP: P < 0.04). Thirty patients treated unsuccessfully with EAM800 × 5 and EAM400 × 10 were re-treated with EAM800 × 10 with an eradication rate of 86.7% (ITT) and 92.2% (PP). Nineteen patients with positive UBT after EAM800 × 10 and EAM800 × 7 underwent a second-line rifabutin-based therapy with an eradication rate of 84.2% (ITT and PP).

Conclusion

A triple therapy with 800 mg of moxifloxacin a day for 10 days is more effective than the same treatment for 5 or 7 days and a treatment with 400 mg of moxifloxacin a day for 10 days for the first-line eradication of H. pylori infection. The high cost of moxifloxacin-based treatment however, may limit its wide use as first-line treatment of H. pylori infection.

Introduction

The current first-line treatment for H. pylori infection implies the use of a PPI with two antibiotics, clarithromycin and amoxicillin, or metronidazole in association with clarithromycin or amoxicillin. The recent consensus conference on this issue in Europe has suggested that clarithromycin should be used in areas where resistance rate is less than 15–20% of tested strains and less than 40% for metronidazole [1]. These guidelines are also followed in Italy as indicated by the Cervia II Working Group Report [2]. In addition, the Italian group recommends using a 14-day triple therapy with clarithromycin and metronidazole as a first-line approach where the prevalence of clarithromycin resistance is >15–20%. A sequential therapy as first-line treatment is also suggested due to the evidence of high eradication rate even in the case of clarithromycin resistance [3]. To overcome antibiotic resistance it is also reasonable to search for new antibiotics with a high sensitivity for H. pylori. In this search three main points should be taken into consideration. The first is the necessity to study and monitor antibiotic resistance in local areas, the second is the necessity to find new antibiotics with a lower resistance than clarithromycin and metronidazole, and the third is to find the proper dosage of the newly identified antibiotic for an optimal therapeutic outcome. Primary resistance of H. pylori of strains collected from patients who have never been treated in the past for H. pylori infection to fluoroquinolones has been reported to be lower than that of clarithromycin in several geographic areas [4]. In a previous study [5] we showed that in our geographical area the resistance rate to levofloxacin and moxifloxacin is between 10% and 12%, with a slightly lower percentage for moxifloxacin in comparison with levofloxacin [6]. In this area clarithromycin resistance is present in about 20% of the strains cultured from patients never treated for the infection [7]. Several papers have been published on triple therapy that include levofloxacin [8], [9] or moxifloxacin [10], [11], [12], [13], [14] as a first-line therapy in patients infected by H. pylori. Dosages and length of treatment have not been standardized yet, and the results of these trials describe contrasting results with eradication rates ranging from 40% to 90% of treated cases. The aim of the study was to evaluate the therapeutic efficacy of an association of moxifloxacin, amoxicillin and proton pump inhibitors (PPI) in four different regimens, in previously untreated patients infected by H. pylori.

Section snippets

Materials and methods

The study was carried out from June 2006 to August 2008 as a randomized, open label, comparative clinical trial with four groups of patients.

Results

Ninety-four, 102, 98 and 105 patients were recruited in groups EAM800 × 10, EAM800 × 7, EAM800 × 5, and EAM400 × 10 respectively. Four patients in the EAM800 × 10 group, five patients in the EAM800 × 7 group, four patients in the EAM800 × 5 group, and six patients in the EAM400 × 10 group did not return for the control. The drug acceptance was good, and almost all patients were able to complete the study. Drop outs included one patient in the EAM800 × 7 group and one patient in the EAM800 × 5 group who interrupted

Discussion

This study shows that a triple therapy that includes amoxicillin, moxifloxacin and esomeprazole may be successfully used for first-line treatment of H. pylori infection with an eradication rate of up to 94%. It is also shown that the optimal dosage and length of treatment of moxifloxacin is 400 mg twice daily for a period of 10 days.

Moxifloxacin has already been used in the first-line treatment of H. pylori infection with variable success. The first reports published by Di Caro et al. [8] showed

Conflict of interest

None declared.

Acknowledgment

The authors thank Mrs. Catherine Hlywka for reviewing the English style of the manuscript.

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