Helicobacter pylori first-line treatment and rescue option containing levofloxacin in patients allergic to penicillin
Received 24 February 2009; accepted 10 June 2009. published online 27 July 2009.
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 (20mg b.i.d.), clarithromycin (500mg b.i.d.) and metronidazole (500mg b.i.d.) for 7 days. Second-line treatment (15 therapy failures out of the aforementioned 50 patients): Omeprazole (20mg b.i.d.), clarithromycin (500mg b.i.d.) and levofloxacin (500mg b.i.d.) for 10 days. Outcome variable: Negative 13C-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.
aGastroenterology Unit, Hospital Universitario de la Princesa and Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Spain
bGastroenterology Unit, Hospital Costa del Sol, Málaga, Spain
cGastroenterology Unit, Hospital de Valme, Sevilla, Spain
dGastroenterology Unit, Hospital Río Hortega, Valladolid, Spain
eGastroenterology Unit, Hospital Central de Asturias, Oviedo, Spain
fGastroenterology Unit, Hospital de Donostia and CIBEREHD, San Sebastián, Spain
ABSTRACT