Levofloxacin-based triple therapy in first-line treatment for Helicobacter pylori eradication.
BACKGROUND
The standard first-line therapies for Helicobacter pylori eradication are based on clarithromycin and amoxicillin or metronidazole. Recent studies suggested levofloxacin as an alternative option for both first-and second-line H. pylori eradication treatment.


OBJECTIVE
To compare efficacy and tolerability of two different 7-day standard triple therapies versus 7-day levofloxacin-based triple therapy in first-line treatment for H. pylori infection.


METHODS
Three hundred consecutive H. pylori positive patients were randomized to receive: clarithromycin, amoxicillin, esomeprazole (Group A: N = 100); clarithromycin, metronidazole, esomeprazole (Group B: N = 100); or clarithromycin, levofloxacin, esomeprazole (Group C: N = 100). H. pylori status was rechecked by (13)C urea breath test 6 wk after the end of therapy.


RESULTS
Sixteen out of 300 patients discontinued treatment because of the occurrence of side effects (Group A, 5; Group B, 7; Group C, 4). The eradication rates in intention to treat (ITT) and per protocol (PP) analyses were: Group A, 75% and 79%; Group B, 72% and 77.4%; and Group C, 87% and 90.6%. The eradication rate achieved with levofloxacin-based triple therapy was significantly higher than that with standard therapies in either ITT (87%vs 75%, p <0.05; 87%vs 72%, p <0.01;) or PP analysis (90.6%vs 79%, p <0.05; 90.6 vs 77.4, p <0.05). No difference was found between standard triple therapies. The incidence of side effects was similar among groups.


CONCLUSIONS
A 7-day levofloxacin-based triple therapy can achieve higher H. pylori eradication rates than standard regimens. These data suggest levofloxacin-based regimens can be the most effective in first-line anti-H. pylori therapy, at least in the Italian population.
Nista
Enrico C
EC
Department of Internal Medicine, Catholic University, Rome, Italy.
Candelli
Marcello
M
Zocco
Maria A
MA
Cremonini
Filippo
F
Ojetti
Veronica
V
Finizio
Rosalba
R
Spada
Cristiano
C
Cammarota
Giovanni
G
Gasbarrini
Giovanni
G
Gasbarrini
Antonio
A
D000293:Adolescent; D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D001706:Biopsy; D017291:Clarithromycin / Q000627:therapeutic use; D004359:Drug Therapy, Combination; D016099:Endoscopy, Gastrointestinal; D004791:Enzyme Inhibitors / Q000627:therapeutic use; D064098:Esomeprazole / Q000627:therapeutic use; D005260:Female; D005500:Follow-Up Studies; D005753:Gastric Mucosa / Q000382:microbiology / Q000473:pathology; D005756:Gastritis / Q000188:drug therapy* / Q000453:epidemiology / Q000382:microbiology; D016481:Helicobacter Infections / Q000188:drug therapy* / Q000453:epidemiology / Q000382:microbiology; D016480:Helicobacter pylori / Q000187:drug effects / Q000302:isolation & purification*; D006801:Humans; D064704:Levofloxacin; D008297:Male; D008795:Metronidazole / Q000627:therapeutic use; D008875:Middle Aged; D015242:Ofloxacin / Q000627:therapeutic use*; D011446:Prospective Studies; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D004791:Enzyme Inhibitors; D008795:Metronidazole; D064704:Levofloxacin; D015242:Ofloxacin; D017291:Clarithromycin; D064098:Esomeprazole