H pylori

Aliment Pharmacol Ther 2005; 21: 1241–1247.

doi: 10.1111/j.1365-2036.2005.02412.x

Moxifloxacin-based strategies for first-line treatment of Helicobacter pylori infection
E. C. N ISTA *, M. CAND ELLI*, M. A . ZOCCO*, I. A. CAZZATO*, F. CREM ONINI*, V. OJETTI*, M. SA NTORO*, R. FINIZIO*, G. PIGN ATARO*, G. CAMM AROTA*, G. GASBARRIN I* & A. GA SBARR INI  Departments of *Internal Medicine and Medical Pathology, Catholic University, Rome, Italy
Accepted for publication 23 January 2005

SUMMARY

Background: Standard anti-Helicobacter pylori therapy may not achieve a satisfactory eradication rate. Fluoroquinolones, such as moxifloxacin, are safe and promising agents for H. pylori eradication. Aim: To compare the efficacy of two 1-week moxifloxacin-based H. pylori eradication regimens withtwo standard treatments. Methods: Three hundred and twenty H. pylori-positive subjects were randomized into four groups to receive: moxifloxacin, amoxicillin, esomeprazole (Group MAE); moxifloxacin, tinidazole and esomeprazole (Group MTE); standard triple therapies with clarithromycin, amoxicillin and esomeprazole (Group CAE) or tinidazole (Group CTE) for 7 days. H. pylori status was re-assessed 6weeks after the end of therapy by 13C urea breath test.

Results: Three hundred and twenty patients completed the efficacy analysis per protocol; H. pylori eradication rate in group MTE was 90% (72 of 80) and 92% (72 of 78), in group MAE was 88% (70 of 80) and 89%, (70 of 79) in Group CAE was 73% (58 of 80) and 78% (58 of 74), and in Group CTE was 75% (60 of 80) and 79% (60 of 76), respectively,in intention-to-treat and in per protocol analyses. Eradication rates of moxifloxacin-based triple therapies were significantly higher than that observed using standard triple schemes. The incidence of side effects was significantly lower in moxifloxacin groups than in control groups. Conclusions: Seven-day moxifloxacin-based triple therapies provide optimal eradication rates with a good compliancewhen compared with the standard triple therapy schemes.

INTRODUCTION

Helicobacter pylori infection is the main pathogenic factor in the development of chronic gastritis, peptic ulcer and gastric malignancies. Considering the worldwide diffusion of H. pylori and the possible severe complications of chronic infection, the availability of efficacious treatment options is essential.Correspondence to: Prof. A. Gasbarrini, Catholic University, Gemelli Hospital, Largo A Gemelli 8, 00168 Rome, Italy. E-mail: angiologia@rm.unicatt.it Ó 2005 Blackwell Publishing Ltd

The guidelines established by several International Consensus Conference suggest the use of a first-line therapy based on two antibiotics, clarithromycin (500 mg b.d.) and amoxicillin (1 g b.d.) or nitroimidazole (500 mg b.d.)associated with a proton pump inhibitor (b.d.) for 7 days. The eradication rate of this scheme is variable in different studies ranging from 70 to 85%.1, 2 Patients’ compliance and bacterial resistance are some of the factors involved in treatment’s failure.3 For this reason new antibiotic associations and simpler eradication regimens are needed. However, in western country the major cause oftreatment failure remains the resistance to clarithromycin. The wide use
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of such antibiotic for community acquired upper and lower respiratory diseases and for otitis probably can explain the increasing resistance of H. pylori in general population. To overcome this problem different classes of antibiotics such as fluoroquinilones, rifabutin and newer macrolideshave been used with variable rates of success.4–6 In particular, some studies have evaluated the efficacy and tolerability of new fluoroquinolones, such as levofloxacin, that could provide a valid alternative to standard antibiotics and, more interesting, a useful way to overcome the occurrence of primary resistance to macrolides and nitroimidazoles.7 Among antibacterial agents currently under...