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

Abstract Aim To assess the efficacy and tolerability of Helicobacter pylori 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 b.i.d.), clarithromycin (500 mg b.i.d.) and metronidazole (500 mg b.i.d.) for 7 days. Second-line treatment (15 therapy failures out of the aforementioned 50 patients): Omeprazole (20 mg b.i.d.), clarithromycin (500 mg b.i.d.) and levofloxacin (500 mg b.i.d.) for 10 days. 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, 1 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 (1 patient). Conclusion In H. pylori 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.