Original Contribution
The American Journal of Gastroenterology (2006) 101, 1985–1990; doi:10.1111/j.1572-0241.2006.00716.x
Levofloxacin-Based Triple Therapy in First-Line Treatment for Helicobacter pylori Eradication
Enrico C Nista MD1, Marcello Candelli MD1, Maria A Zocco MD1, Filippo Cremonini MD1, Veronica Ojetti MD1, Rosalba Finizio MD1, Cristiano Spada MD1, Giovanni Cammarota MD1, Giovanni Gasbarrini MD1 and Antonio Gasbarrini MD2
- 1Department of Internal Medicine, Catholic University, Rome, Italy
- 2Department of Medical Pathology, Catholic University, Rome, Italy
Correspondence: Antonio Gasbarrini, Professor of Internal Medicine, Catholic University, Gemelli Hospital, Largo A Gemelli 8, 00168 Rome, Italy.
Received 14 November 2005; Accepted 18 March 2005.
Abstract
BACKGROUND:
The standard first-line therapies for Helicobacter pylori eradication are based on clarithromycin and amoxicillin or metronidazole. Recent studies suggested levofloxacin as an alternative option for both first-and second-line H. pylori eradication treatment.
AIMS:
To compare efficacy and tolerability of two different 7-day standard triple therapies versus 7-day levofloxacin-based triple therapy in first-line treatment for H. pylori infection.
METHODS:
Three hundred consecutive H. pylori positive patients were randomized to receive: clarithromycin, amoxicillin, esomeprazole (Group A: N = 100); clarithromycin, metronidazole, esomeprazole (Group B: N = 100); or clarithromycin, levofloxacin, esomeprazole (Group C: N = 100). H. pylori status was rechecked by 13C urea breath test 6 wk after the end of therapy.
RESULTS:
Sixteen out of 300 patients discontinued treatment because of the occurrence of side effects (Group A, 5; Group B, 7; Group C, 4). The eradication rates in intention to treat (ITT) and per protocol (PP) analyses were: Group A, 75% and 79%; Group B, 72% and 77.4%; and Group C, 87% and 90.6%. The eradication rate achieved with levofloxacin-based triple therapy was significantly higher than that with standard therapies in either ITT (87% vs 75%, p <0.05; 87% vs 72%, p <0.01;) or PP analysis (90.6% vs 79%, p <0.05; 90.6 vs 77.4, p <0.05). No difference was found between standard triple therapies. The incidence of side effects was similar among groups.
CONCLUSIONS:
A 7-day levofloxacin-based triple therapy can achieve higher H. pylori eradication rates than standard regimens. These data suggest levofloxacin-based regimens can be the most effective in first-line anti-H. pylori therapy, at least in the Italian population.
