7-day triple therapy of Helicobacter pylori infection with levofloxacin, amoxicillin, and high-dose esomeprazole in patients with known antimicrobial sensitivity.
OBJECTIVE
Failed primary anti-Helicobacter pylori therapy results in a high rate of antimicrobial resistance. This necessitates a search for new regimens to cure H. pylori infection. The aim of this study was to evaluate the efficacy and tolerability of a new levofloxacin-containing 7-day triple therapy and to compare it with that of standard French triple therapy in patients with known H. pylori susceptibility to MET (metronidazole) and CLA (clarithromycin).


METHODS
Sixty-one patients with documented antibiotic sensitivity (E-test) and an indication for anti-H. pylori treatment based on the Maastricht Consensus 2/2000 guidelines were randomized to receive either esomeprazole 2 x 40 mg, levofloxacin 2 x 500 mg, and amoxicillin 2 x 1 g for 7 days (ELA, n = 30), or esomeprazole 2 x 20 mg, clarithromycin 2 x 500 mg, and amoxicillin 2 x 1 g for 7 days (ECA, n = 31). A cure check was performed 4-6 weeks after conclusion of therapy.


RESULTS
Sixty-one patients were randomized to the two treatment groups. Twenty-eight of 30 patients of the ELA group were available for per-protocol (PP) analysis, of whom 26 (92.9% CI: 76-99%; intention-to-treat [ITT] analysis 86.7% CI: 68-96%) became H. pylori negative compared with 26 of the 31 patients of the ECA group (83.9%, CI: 66-93% both PP and ITT analyses). Five patients of the ELA group showed CLA resistance, three of whom also showed MET resistance, and all five were treated successfully. Two patients with levofloxacin-resistant strains, one in each group, were cured. Both regimens were generally well tolerated with minor adverse events being seen in 15 patients (51.7%) of the ELA group and in 13 (40.6%) of the ECA group. None of the patients discontinued treatment prematurely due to adverse events.


CONCLUSIONS
The data of this pilot study suggest a better than 80% efficacy of the new 7-day levofloxacin triple therapy, which is within the range of the French triple therapy in patients with MET- and CLA-susceptible strains. The data suggest that the new levofloxacin triple therapy may also be an option in patients with MET- and CLA-resistant H. pylori strains.
Antos
David
D
Clinic for Pediatric Diseases, Ludwigs-Maximilians-University, Munich, Germany.
Schneider-Brachert
Wulf
W
Bästlein
Elke
E
Hänel
Christine
C
Haferland
Christian
C
Buchner
Michael
M
Meier
Eberhard
E
Trump
Friedrich
F
Stolte
Manfred
M
Lehn
Norbert
N
Bayerdörffer
Ekkehard
E
D000328:Adult; D000368:Aged; D000658:Amoxicillin / Q000009:adverse effects / Q000627:therapeutic use; D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000627:therapeutic use*; D017291:Clarithromycin / Q000494:pharmacology; D004305:Dose-Response Relationship, Drug; D024881:Drug Resistance, Bacterial; D064098:Esomeprazole / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy* / Q000382:microbiology; D016480:Helicobacter pylori / Q000187:drug effects* / Q000472:pathogenicity; D006801:Humans; D064704:Levofloxacin; D008297:Male; D008795:Metronidazole / Q000494:pharmacology; D008826:Microbial Sensitivity Tests; D008875:Middle Aged; D015242:Ofloxacin / Q000009:adverse effects / Q000627:therapeutic use; D011446:Prospective Studies; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D008795:Metronidazole; D064704:Levofloxacin; D000658:Amoxicillin; D015242:Ofloxacin; D017291:Clarithromycin; D064098:Esomeprazole