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

Gisbert, J.P.; Pérez-Aisa, A.; Castro-Fernández, M.; Barrio, J.; Rodrigo, L.; Cosme, A.; Gisbert, J.-L.; Marcos, S.; Moreno-Otero, R.

doi:10.1016/j.dld.2009.06.007

« Previous Next »Digestive and Liver Disease
Volume 42, Issue 4 , Pages 287-290, April 2010

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

J.P. Gisbert
- Gastroenterology Unit, Hospital Universitario de la Princesa and Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Spain
- Corresponding author at: Playa de Mojácar 29, Urb. Bonanza, 28669 Boadilla del Monte, Madrid, Spain. Tel.: +34 915202254; fax: +34 913093911.
A. Pérez-Aisa
- Gastroenterology Unit, Hospital Costa del Sol, Málaga, Spain
M. Castro-Fernández
- Gastroenterology Unit, Hospital de Valme, Sevilla, Spain
J. Barrio
- Gastroenterology Unit, Hospital Río Hortega, Valladolid, Spain
L. Rodrigo
- Gastroenterology Unit, Hospital Central de Asturias, Oviedo, Spain
A. Cosme
- Gastroenterology Unit, Hospital de Donostia and CIBEREHD, San Sebastián, Spain
J.-L. Gisbert
- Gastroenterology Unit, Hospital Universitario de la Princesa and Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Spain
S. Marcos
- Gastroenterology Unit, Hospital Universitario de la Princesa and Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Spain
R. Moreno-Otero
- Gastroenterology Unit, Hospital Universitario de la Princesa and Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Spain

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.

Abbreviations: H. pylori, Helicobacter pylori, PPI, proton pump inhibitor

Keywords: Allergic, Eradication, Helicobacter pylori, Levofloxacin, Penicillin, Rescue