Levofloxacin versus clarithromycin in a 10 day triple therapy regimen for first-line Helicobacter pylori eradication: a single-blind randomized clinical trial.
BACKGROUND
There is growing evidence that the standard triple therapy against Helicobacter pylori infection is losing clinical effectiveness. A triple therapy regimen with levofloxacin, amoxicillin and a proton pump inhibitor has been reported to be effective and well tolerated, and this regimen has been suggested as an alternative first-line treatment. The aim of this single-blind randomized clinical trial was to compare the eradication success of two first-line triple therapy regimens in the north of Spain: clarithromycin, amoxicillin and omeprazole (CAO) versus levofloxacin, amoxicillin and omeprazole (LAO).


METHODS
A total of 250 consecutive patients diagnosed by conventional methods with H. pylori infection were randomized into one of two 10 day therapeutic regimens: standard CAO (n = 128) or LAO (n = 122). Eradication was confirmed by the (13)C-urea breath test. Adverse effects and compliance were also assessed. The clinical trial registration number was HPL08001HCLAD (EudraCT: 2008-001892-31).


RESULTS
Intention-to-treat cure rates were: CAO, 75.0% (96/128; 95% CI: 66.6%-82.2%) and LAO, 82.8% (101/122; 95% CI: 74.9%-89.0%). Per-protocol cure rates were: CAO, 78.0% (96/123; 95% CI: 69.7%-85.0%) and LAO, 83.1% (98/118; 95% CI: 75.0%-89.3%). There were no statistically significant differences in effectiveness between the two regimens. In addition, no relevant differences in compliance or adverse effects were demonstrated.


CONCLUSIONS
Levofloxacin-based treatment for H. pylori infection did not improve upon the eradication rate of the standard clarithromycin-based triple therapy in this study. This may reflect the progressive increase in in vitro resistance rates to levofloxacin observed in our region.
Department of Gastroenterology,  Hospital of Laredo-Instituto de Formación e Investigación Marqués de Valdecilla (IFIMAV), Avda Derechos Humanos s/n, 39770 Laredo, Cantabria,  Spain.
Antonio
A
Cuadrado-Lavín
J Ramón
JR
Salcines-Caviedes
Miguel F
MF
Carrascosa
Trinidad
T
Dierssen-Sotos
Marta
M
Cobo
M Rosario
MR
Campos
Blanca
B
Ayestarán
Antonio
A
Fernández-Pousa
Elena
E
González-Colominas
Santiago
S
Aresti-Zárate
Mónica
M
Hernández
Encarna Lozano
EL
Pascual
D000293:Adolescent; D000328:Adult; D000368:Aged; D000658:Amoxicillin / Q000008:administration & dosage; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D001944:Breath Tests; D017291:Clarithromycin / Q000008:administration & dosage*; D004359:Drug Therapy, Combination / Q000379:methods; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy*; D006801:Humans; D064704:Levofloxacin; D008297:Male; D008875:Middle Aged; D015242:Ofloxacin / Q000008:administration & dosage*; D054328:Proton Pump Inhibitors / Q000008:administration & dosage; D016037:Single-Blind Method; D013030:Spain; D013997:Time Factors; D016896:Treatment Outcome; D014508:Urea / Q000032:analysis; D055815:Young Adult
D000900:Anti-Bacterial Agents; D054328:Proton Pump Inhibitors; D064704:Levofloxacin; D000658:Amoxicillin; D014508:Urea; D015242:Ofloxacin; D017291:Clarithromycin