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1130-0108/2009/101/6/395-402 REVISTA ESPAÑOLA DE ENFERMEDADES DIGESTIVAS Copyright © 2009 ARÁN EDICIONES, S. L.

REV ESP ENFERM DIG (Madrid) Vol. 101. N.° 6, pp. 395-402, 2009

Efficacy of triple therapy with a proton pump inhibitor, levofloxacin, and amoxicillin as first-line treatment to eradicate Helicobacter pylori
M. Castro-Fernández, E. Lamas, A. Pérez-Pastor, M. Pabón, R. Aparcero, J.Vargas-Romero, J. L. Larraona and M. Romero-Gómez
Unit for the Clinical Management of Digestive Diseases and CIBERehd. Hospital Universitario de Valme. Sevilla, Spain

Background: triple therapy including a proton pump inhibitor, clarithromycin, and amoxicillin (PPI-CA) is the first-choice treatment used for H. pylori eradication. The efficacy of this treatment is declining of late,and alternative therapies are currently under evaluation. Objectives: to evaluate the efficacy, safety and compliance of a triple therapy with a PPI, amoxicillin and levofloxacin (PPI-LA) - replacing clarithromycin - for the eradication of H. pylori. Methods: the study included 135 patients (65% women), mean age 53 years, with dyspeptic symptoms and H. pylori infection proven by a positive ureaserapid test, histological analysis, or C13-urea breath test. Diagnosis: non-investigated dyspepsia 48.9%, functional dyspepsia 36.3%, and ulcerative dyspepsia 14.8%. Treatment was indicated with a proton pump inhibitor at usual doses, amoxicillin 1 g, and levofloxacin 500 mg, administered jointly during breakfast and dinner for 10 days. We studied the performance of this triple therapy and itseffects using a questionnaire, and effectiveness by the negativity of the C13-urea breath test after 6-8 weeks after treatment discontinuation. Per protocol, we compared the effectiveness of PPI-LA with a control group of 270 patients treated with PPI-CA for 10 days. Results: 130 patients (96.2%) could complete the treatment and follow-up protocol. Effectiveness (intention to treat) was 71.8% (97/135)and 74.6% (per protocol) (97/130). Sixteen patients (11.8%) had well-tolerated adverse effects, except for 5 subjects (3.7%) who dropped out. PPI-CA was effective (per protocol) in 204 patients out of 270 (75.5%) in the control group. Conclusions: triple therapy with a PPI, amoxicillin and levofloxacin for 10 days is a well-tolerated treatment that is easy to comply with; however it has lowefficiency - less than 80% - and is not recommended as a first-choice treatment for H. pylori eradication. Similar results were obtained with the classic triple therapy using a PPI, clarithromycin and amoxicillin.

Key words: Triple therapy. Levofloxacin. Helicobacter pylori.

Castro-Fernández M, Lamas E, Pérez-Pastor A, Pabón M, Aparcero R, Vargas-Romero J, Larraona JL, Romero-Gómez M. Efficacy oftriple therapy with a proton pump inhibitor, levofloxacin, and amoxicillin as first-line treatment to eradicate Helicobacter pylori. Rev Esp Enferm Dig 2009; 101: 395-402.

Triple therapy combining a proton pump inhibitor (PPI) with two antibiotics, preferably clarithromycin and amoxicillin (PPI-CA), is the first-choice treatment in the eradication of Helicobacter pylori (H. pylori) (1-3). Theefficacy of this treatment has declined in recent years, being now usually below 80% and, in some studies, lower than 70% (4-9), probably due to increased resistance to clarithromycin. Recent publications show a higher efficacy (> 80%) of a new triple therapy combining a PPI, amoxicillin and levofloxacin (PPI-LA) replacing clarithromycin as first-line treatment to eradicate H. pylori, this beingconsidered an alternative treatment because of the lack of effectiveness of triple therapy with PPI-CA (10-15). In this study we determined the effectiveness, compliance and safety of PPI-LA triple therapy for 10 days, given as firstline treatment to eradicate H. pylori in our health area. Study design: a prospective, observational, single-center study. Period of study: 2007-2008. We included 135...