Levofloxacin versus clarithromycin in a 10 day triple therapy regimen for first-line Helicobacter pylori eradication: a single-blind randomized clinical trial

There is growing evidence that the standard triple therapy against Helicobacter pylori infection is losing clinical effectiveness. A triple therapy regimen with levofloxacin, amoxicillin and a proton pump inhibitor has been reported to be effective and well tolerated, and this regimen has been suggested as an alternative first-line treatment. The aim of this single-blind randomized clinical trial was to compare the eradication success of two first-line triple therapy regimens in the north of Spain: clarithromycin, amoxicillin and omeprazole (CAO) versus levofloxacin, amoxicillin and omeprazole (LAO). A total of 250 consecutive patients diagnosed by conventional methods with H. pylori infection were randomized into one of two 10 day therapeutic regimens: standard CAO (n128) or LAO (n122). Eradication was confirmed by the C-13-urea breath test. Adverse effects and compliance were also assessed. The clinical trial registration number was HPL08001HCLAD(EudraCT: 2008-001892-31). Intention-to-treat cure rates were: CAO, 75.0 (96/128; 95 CI: 66.682.2) and LAO, 82.8 (101/122; 95 CI: 74.989.0). Per-protocol cure rates were: CAO, 78.0 (96/123; 95 CI: 69.785.0) and LAO, 83.1 (98/118; 95 CI: 75.089.3). There were no statistically significant differences in effectiveness between the two regimens. In addition, no relevant differences in compliance or adverse effects were demonstrated. Levofloxacin-based treatment for H. pylori infection did not improve upon the eradication rate of the standard clarithromycin-based triple therapy in this study. This may reflect the progressive increase in in vitro resistance rates to levofloxacin observed in our region.