Second-Line Rescue Therapy With Levofloxacin After H. pylori Treatment Failure: A Spanish Multicenter Study of 300 Patients

Authors: Gisbert, Javier P.¹; Bermejo, Fernando²; Castro-Fernández, Manuel³; Pérez-Aisa, Angeles⁴; Fernández-Bermejo, Miguel⁵; Tomas, Albert⁶; Barrio, José⁷; Bory, Felipe⁸; Almela, Pedro⁹; Sánchez-Pobre, Pilar¹⁰; Cosme, Angel¹¹; Ortiz, Vicente¹²; Niño, Pilar¹³; Khorrami, Sam¹⁴; Benito, Luis-Miguel¹⁵; Carneros, Jose-Antonio²; Lamas, Eloisa³; Modolell, Inés⁶; Franco, Alejandro¹⁰; Ortuño, Juan¹²; Rodrigo, Luis¹³; García-Durán, Fernando²; O'Callaghan, Elena⁶; Ponce, Julio¹²; Valer, María-Paz²; Calvet, Xavier¹⁶

Source: The American Journal of Gastroenterology, Volume 103, Number 1, January 2008 , pp. 71-76(6)

Publisher: Blackwell Publishing

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Abstract:

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.

(Am J Gastroenterol 2007;102:71-76)

Document Type: Research article

DOI: 10.1111/j.1572-0241.2007.01500.x

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

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