Eradication of Helicobacter pylori with lansoprazole, roxithromycin and metronidazole - an open pilot study

Background: The most extensively studied Helicobacter pylori eradication re gimen comprises omeprazole, clarithromycin and metronidazole. Macrolide ant ibiotics other than clarithromycin should achieve similar efficacy, but the y have not yet been thoroughly tested. Aim: To determine the efficacy and safety of a triple therapy regimen using lansoprazole, roxithromycin, and metronidazole on the basis of multicentre outpatient care in an open pilot study. Methods: 163 patients with duodenal ulcer and proven H. Pylori infection re ceived lansoprazole 30 mg b.d,, roxithromycin 300 mg b,d, and metronidazole 500 mg b,d. for 7 days followed by another 7 days of lansoprazole 30 mg on ce daily, H. pylori status was determined by urease quick. test, histology, microbiology and C-13-urea breath test before starting and at least 4 week s after completing treatment. Results: 150 patients were available for evaluation; H. pylori was successf ully eradicated in 84.7% (127/ 150) as determined by urease quick test, 78. 0% (117/ 150) by histology, 81.3% (109/134) by C-13-utea breath test; and i n 75.3% (113/150), at least two tests were negative. Side-effects were repo rted in 34 patients (most commonly diarrhoea and changes in liver function tests), in two cases the study medication was interrupted, Prior to treatme nt, 23% of the H, pylori isolates were resistant against metronidazole and 3.4% against roxithromycin, After unsuccessful treatment, 84% of the isolat es were resistant against metronidazole and 21% against roxithromycin. Prim ary resistance to metronidazole increased the chance of treatment failure a pproximately sevenfold (7% vs. 53%). Conclusions: For H. pylori eradication, the combination of lansoprazole, ro xithromycin and metronidazole proved to be as safe as other current triple therapy regimens, while a comparison of efficacy rates yet remains to be as sessed in prospective controlled trials. The metronidazole-resistant H. pyl ori is not rare in Germany and, in the present study, has strongly influenc ed treatment success.