Clinical trial: clarithromycin vs. levofloxacin in first-line triple and sequential regimens for Helicobacter pylori eradication

Javier Molina Infante (1) , Belen Perez Gallardo (2) , Miguel Fernandez Bermejo (2, 3) , Moises Hernandez Alonso (2) , Gema Vinagre (2) , Carmen Dueñas (2) , Jose Maria Mateos Rodriguez (2) , Guadalupe Gonzalez Garcia (2) , Elena Garcia Abadia (2) , Javier P Gisbert (4)

1 Gastroenterology
2 Gastroenterology
3 Gastroenterology
4 Gastroenterology

BACKGROUND: Helicobacter pylori eradication rates with standard triple therapy have declined to unacceptable levels. AIM: To compare clarithromycin and levofloxacin in triple and sequential first-line regimens. METHODS: 460 patients were randomized into four 10-day therapeutic schemes (115 patients per group): (1) standard OCA, omeprazole, clarithromycin and amoxicillin; (2) triple OLA, omeprazole, levofloxacin and amoxicillin; (3) sequential OACM, omeprazole plus amoxicillin for 5 days, followed by omeprazole plus clarithromycin plus metronidazole for 5 days, and (4) modified sequential OALM, using levofloxacin instead of clarithromycin. Eradication was confirmed by 13C-urea breath test. Adverse effects and compliance were assessed by a questionnaire. RESULTS: Per protocol cure rates were: OCA (66%; 95%CI: 57-74%), OLA (82.6%; 75-89%), OACM (80.8%; 73-88%), and OALM (85.2%; 78-91%). Intention to treat cure rates were: OCA (64%; 55-73%), OLA (80.8%; 73-88%), OACM (76.5%; 69-85%), and OALM (82.5%; 75-89%). Eradication rates were lower with OCA than with all the other regimens (p<0.05). No differences in compliance or adverse effects were demonstrated among treatments. CONCLUSIONS: Levofloxacin-based and sequential therapy are superior to standard triple scheme as first-line therapy in a setting with high clarithromycin resistance. However, all of these therapies still have a 20% failure rate.

Mots clés: Medicine

Javier Molina Infante, Belen Perez Gallardo, Miguel Fernandez Bermejo, Moises Hernandez Alonso, Gema Vinagre, et al.. Clinical trial: clarithromycin vs. levofloxacin in first-line triple and sequential regimens for Helicobacter pylori eradication. Alimentary Pharmacology and Therapeutics, 2010, ⟨10.1111/j.1365-2036.2010.04274.x⟩. ⟨hal-00552534⟩