Helicobacter pylori first-line treatment and rescue option containing levofloxacin in patients allergic to penicillin

Aim: To assess the efficacy and tolerability of Helicobacter pylon first-line treatment (omeprazole-clarithromycin-metronidazole) and second-line rescue option (omeprazole-clarithromycin-levofloxacin) in patients allergic to penicillin. Methods: Patients: Prospective multicenter study including consecutive patients allergic to penicillin. Therapy regimens: First-line treatment (50 patients): Omeprazole (20 mg bid.), clarithromycin (500 mg bid.) and metronidazole (500 mg bid.) for 7 days. Second-line treatment (15 therapy failures out of the aforementioned 50 patients): Omeprazole (20 mg bid.), clarithromycin (500 mg bid.) and levofloxacin (500 mg bid.) for 10 clays. Outcome variable: Negative (13)C-urea breath test 8 weeks after completion of treatment. Results: (1) First-line treatment (omeprazole-clarithromycin-metronidazole): Per-protocol and intention-to-treat eradication rates were 55% (27/49; 95%CI = 40-70%) and 54% (27/50; 95%CI = 39-69%). Compliance with treatment and follow-up was complete in 98% of cases (one patient was not compliant due to nausea). Adverse events were reported in 5 patients (10%): 4 nausea, I diarrhoea. (2) Second-line treatment (omeprazole-clarithromycin-levofloxacin): Per-protocol and intention-to-treat eradication rates were both 73% (11/15; 95%CI = 45-92%). Compliance with treatment and follow-up was complete in all the cases. Adverse events were reported in 4 patients (20%), which did not prevent the completion of treatment: Mild nausea (2 patients), and vomiting and myalgias/arthralgias ( I patient). Conclusion: In H. pylon infected patients allergic to penicillin, the generally recommended first-line treatment with omeprazole, clarithromycin and metronidazole has low efficacy for curing the infection. On the other hand, a levofloxacin-containing regimen (together with omeprazole and clarithromycin) represents an encouraging second-line alternative in the presence of penicillin allergy. (C) 2009 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.