Cumulative H. pylori eradication rates in clinical practice by adopting first and second-line regimens proposed by the Maastricht III consensus and a third-line empirical regimen.

OBJECTIVES

The European Helicobacter Study Group has recently issued the current concepts in the management of Helicobacter pylori infection (Maastricht III Consensus Report, 2005). The aim of the study was to examine the cumulative H. pylori eradication rates that can be achieved in clinical practice by adopting first and second regimens as proposed by the Maastricht III consensus and a third-line empirical levofloxacin-based regimen.

METHODS

H. pylori-positive patients were treated initially with a first-line eradication triple regimen consisting of omeprazole, amoxicillin, and clarithromycin and subsequently with a second-line quadruple regimen consisting of omeprazole, bismuth, metronidazole, and tetracycline. Finally, after two previous H. pylori eradication failures, patients received omeprazole, amoxicillin, and levofloxacin, as a third-line empirical strategy. The success rate was calculated by both intention-to-treat (ITT) and per protocol (PP) analyses.

RESULTS

In total, 540 consecutive H. pylori-positive patients received first-line treatment (omeprazole, amoxicillin, and clarithromycin). H. pylori were eradicated in 380 patients and 40 patients were withdrawn (ITT, 70.3%; PP, 76%). The remaining 120 H. pylori-positive patients received second-line treatment (omeprazole, bismuth, metronidazole, and tetracycline). H. pylori were eradicated in 83 patients and 7 patients were withdrawn (ITT, 69.1%; PP, 73.45%). Finally, the remaining 30 H. pylori-positive patients received third-line treatment (omeprazole, amoxicillin, and levofloxacin). H. pylori were eradicated in 21 patients and 0 patients were withdrawn (ITT, 70%; PP, 70%). Thus, out of 540 patients initially included in the study, H. pylori were eradicated in 484 patients, 47 were withdrawn, and only 9 remained positive. These results give 89.6% ITT and 98.1% PP cumulative H. pylori eradication rates.

CONCLUSIONS

By adopting first- and second-line regimens, as proposed by the Maastricht III consensus and a third-line levofloxacin-based empirical regimen, high cumulative H. pylori eradication rates can be achieved. Thus, a substantial number of cultures to determine sensitivity to antibiotics can be avoided with beneficial consequences concerning cost.