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Second-Line Rescue Therapy With Levofloxacin After H. pylori Treatment Failure

A Spanish Multicenter Study of 300 Patients

Gisbert, Javier P., M.D.1; Bermejo, Fernando, M.D.2; Castro-Fernández, Manuel, M.D.3; Pérez-Aisa, Angeles, M.D.4; Fernández-Bermejo, Miguel, M.D.5; Tomas, Albert, M.D.6; Barrio, José, M.D.7; Bory, Felipe, M.D.8; Almela, Pedro, M.D.9; Sánchez-Pobre, Pilar, M.D.10; Cosme, Angel, M.D.11; Ortiz, Vicente, M.D.12; Niño, Pilar, M.D.13; Khorrami, Sam, M.D.14; Benito, Luis-Miguel, M.D.15; Carneros, Jose-Antonio, M.D.2; Lamas, Eloisa, M.D.3; Modolell, Inés, M.D.6; Franco, Alejandro, M.D.10; Ortuño, Juan, M.D.12; Rodrigo, Luis, M.D.13; García-Durán, Fernando, M.D.2; O'Callaghan, Elena, M.D.6; Ponce, Julio, M.D.12; Valer, María-Paz, M.D.2; Calvet, Xavier, M.D.16 The H. pylori Study Group of the Asociación Española de Gastroenterología

American Journal of Gastroenterology: January 2008 - Volume 103 - Issue 1 - p 71–76
ORIGINAL CONTRIBUTIONS: STOMACH
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AIM Quadruple therapy is generally recommended as second-line therapy after Helicobacter pylori (H. pylori) eradication failure. However, this regimen requires the administration of four drugs with a complex scheme, is associated with a relatively high incidence of adverse effects, and bismuth salts are not available worldwide anymore. Our aim was to evaluate the efficacy and tolerability of a triple second-line levofloxacin-based regimen in patients with H. pylori eradication failure.

METHODS Design: Prospective multicenter study. Patients: in whom a first treatment with proton pump inhibitor-clarithromycin-amoxicillin had failed. Intervention: A second eradication regimen with levofloxacin (500 mg b.i.d.), amoxicillin (1 g b.i.d.), and omeprazole (20 mg b.i.d.) was prescribed for 10 days. Outcome: Eradication was confirmed with 13C-urea breath test 4–8 wk after therapy. Compliance with therapy was determined from the interview and the recovery of empty envelopes of medications. Incidence of adverse effects was evaluated by means of a specific questionnaire.

RESULTS Three hundred consecutive patients were included. Mean age was 48 yr, 47% were male, 38% had peptic ulcer, and 62% functional dyspepsia. Almost all (97%) patients took all the medications correctly. Per-protocol and intention-to-treat eradication rates were 81% (95% CI 77–86%) and 77% (73–82%). Adverse effects were reported in 22% of the patients, mainly including nausea (8%), metallic taste (5%), abdominal pain (3%), and myalgias (3%); none of them were severe.

CONCLUSION Ten-day levofloxacin-based rescue therapy constitutes an encouraging second-line strategy, representing an alternative to quadruple therapy in patients with previous proton pump inhibitor-clarithromycin-amoxicillin failure, being simple and safe.

1Hospital de la Princesa, Madrid; 2Hospital de Fuenlabrada, Madrid; 3Hospital de Valme, Sevilla; 4Hospital Costa del Sol, Málaga; 5Hospital San Pedro de Alcántara, Cáceres; 6Hospital General de Cataluña, Barcelona; 7Hospital Río Hortega, Valladolid; 8Hospital del Mar, Barcelona; 9Hospital Clínico, Valencia; 10Hospital 12 de Octubre, Madrid; 11Hospital de Donostia, San Sebastián; 12Hospital La Fe, Valencia; 13Hospital Central de Asturias, Oviedo; 14Hospital Son Llatzer, Palma de Mallorca; 15Hospital Virgen del Toro, Menorca; and 16CIBEREHD, Hospital de Sabadell, Barcelona, Spain

Reprint requests and correspondence: Javier P. Gisbert, M.D., Playa de Mojácar 29. Urb. Bonanza, 28669 Boadilla del Monte, Madrid, Spain.

Received April 20, 2007; accepted July 15, 2007.

CONFLICT OF INTERESTGuarantor of the article: Javier P. Gisbert, M.D.

Specific author contributions: Javier P. Gisbert had the original idea for the study, designed and organized the protocol, performed the statistical analysis of the data, and wrote the manuscript. All the authors treated and included patients in the study and critically reviewed the paper.

Financial support: Supported in part by Grants from the Instituto de Salud Carlos III (C03/02 and PI050109). This study was not funded by any pharmaceutical company.

Potential competing interests: None.

© The American College of Gastroenterology 2008. All Rights Reserved.
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