Eradication of Helicobacter pylori with lansoprazole, roxithromycin and metronidazole--an open pilot study.
BACKGROUND
The most extensively studied Helicobacter pylori eradication regimen comprises omeprazole, clarithromycin and metronidazole. Macrolide antibiotics other than clarithromycin should achieve similar efficacy, but they have not yet been thoroughly tested.


OBJECTIVE
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 received 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 once daily. H. pylori status was determined by urease quick test, histology, microbiology and 13C-urea breath test before starting and at least 4 weeks after completing treatment.


RESULTS
150 patients were available for evaluation; H. pylori was successfully eradicated in 84.7% (127/ 150) as determined by urease quick test, 78.0% (117/150) by histology, 81.3% (109/134) by 13C-urea breath test; and in 75.3% (113/150), at least two tests were negative. Side-effects were reported in 34 patients (most commonly diarrhoea and changes in liver function tests), in two cases the study medication was interrupted. Prior to treatment, 23% of the H. pylori isolates were resistant against metronidazole and 3.4% against roxithromycin. After unsuccessful treatment, 84% of the isolates were resistant against metronidazole and 21% against roxithromycin. Primary resistance to metronidazole increased the chance of treatment failure approximately sevenfold (7% vs. 53%).


CONCLUSIONS
For H. pylori eradication, the combination of lansoprazole, roxithromycin and metronidazole proved to be as safe as other current triple therapy regimens, while a comparison of efficacy rates yet remains to be assessed in prospective controlled trials. The metronidazole-resistant H. pylori is not rare in Germany and, in the present study, has strongly influenced treatment success.
Pohle
T
T
Department of Medicine B, University of Münster, Germany. pohlet@uni-muenster.de
Stoll
R
R
Kirchner
T
T
Heep
M
M
Lehn
N
N
Bock
H
H
Domschke
W
W
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000328:Adult; D000897:Anti-Ulcer Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004352:Drug Resistance, Microbial; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori; D006801:Humans; D064747:Lansoprazole; D008297:Male; D008795:Metronidazole / Q000009:adverse effects / Q000627:therapeutic use; D009853:Omeprazole / Q000009:adverse effects / Q000031:analogs & derivatives / Q000627:therapeutic use; D010865:Pilot Projects; D019338:Polypharmacy; D015575:Roxithromycin / Q000009:adverse effects / Q000627:therapeutic use*
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000897:Anti-Ulcer Agents; D064747:Lansoprazole; D008795:Metronidazole; D015575:Roxithromycin; D009853:Omeprazole