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Third-Line Rescue Therapy with Bismuth-Containing Quadruple Regimen After Failure of Two Treatments (with Clarithromycin and Levofloxacin) for H. pylori Infection

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Abstract

Background

Helicobacter pylori eradication therapy with a proton pump inhibitor (PPI), clarithromycin, and amoxicillin fails in >20 % of cases. A rescue therapy with PPI–amoxicillin–levofloxacin still fails in >20 % of patients.

Aim

To evaluate the efficacy and tolerability of a bismuth-containing quadruple regimen in patients with two consecutive eradication failures.

Methods

Prospective multicenter study of patients in whom 1st treatment with PPI–clarithromycin–amoxicillin and 2nd with PPI–amoxicillin–levofloxacin had failed. A 3rd eradication regimen with a 7- to 14-day PPI (standard dose b.i.d.), bismuth subcitrate (120 mg q.i.d. or 240 mg b.i.d.), tetracycline (from 250 mg t.i.d. to 500 mg q.i.d.) and metronidazole (from 250 mg t.i.d. to 500 mg q.i.d.). Eradication was confirmed by 13C-urea-breath-test 4–8 weeks after therapy. Compliance was determined through questioning and recovery of empty medication envelopes. Adverse effects were evaluated by means of a questionnaire.

Results

Two hundred patients (mean age 50 years, 55 % females, 20 % peptic ulcer/80 % uninvestigated-functional dyspepsia) were initially included, and two were lost to follow-up. In all, 97 % of patients complied with the protocol. Per-protocol and intention-to-treat eradication rates were 67 % (95 % CI 60–74 %) and 65 % (58–72 %). Adverse effects were reported in 22 % of patients, the most common being nausea (12 %), abdominal pain (11 %), metallic taste (8.5 %), and diarrhea (8 %), none of them severe.

Conclusion

A bismuth-containing quadruple regimen is an acceptable third-line strategy and a safe alternative after two previous H. pylori eradication failures with standard clarithromycin- and levofloxacin-containing triple therapies.

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Abbreviations

H. pylori :

Helicobacter pylori

PPI:

Proton pump inhibitor

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Acknowledgment

CIBEREHD is funded by the Instituto de Salud Carlos III. This study was not funded by the Pharmaceutical Industry.

Conflict of interest

None.

Author information

Authors and Affiliations

  1. Gastroenterology Unit, Hospital Universitario de La Princesa and Instituto de Investigación Sanitaria Princesa (IP), Playa de Mojácar 29. Urb. Bonanza., 28669, Boadilla del Monte, Madrid, Spain

    J. P. Gisbert, A. C. Marín & A. G. McNicholl

  2. Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Barcelona, Spain

    J. P. Gisbert, M. Castro-Fernández, A. C. Marín & A. G. McNicholl

  3. Gastroenterology Unit, Agencia Sanitaria Costa del Sol, Málaga, Spain

    A. Perez-Aisa & M. Gonzalez-Barcenas

  4. Gastroenterology Unit, Hospital Central de Asturias, Oviedo, Spain

    L. Rodrigo

  5. Gastroenterology Unit, Hospital San Pedro de Alcántara, Cáceres, Spain

    J. Molina-Infante & M. Fernandez-Bermejo

  6. Gastroenterology Unit, Consorci Sanitari de Terassa, Barcelona, Spain

    I. Modolell

  7. Gastroenterology Unit, Hospital de Fuenlabrada, Madrid, Spain

    F. Bermejo & A. Algaba

  8. Gastroenterology Unit, Hospital de Valme, Sevilla, Spain

    M. Castro-Fernández

  9. Gastroenterology Unit, Hospital Clínico, Valencia, Spain

    R. Antón

  10. Gastroenterology Unit, Hospital San Pedro, Logroño, Spain

    B. Sacristán

  11. Gastroenterology Unit, Hospital Donostia/Instituto Biodonostia, Universidad del Pais Vasco UPV/EHV, San Sebastian, Spain

    A. Cosme

  12. Gastroenterology Unit, Hospital Rio Hortega, Valladolid, Spain

    J. Barrio

  13. Gastroenterology Unit, Hospital de Barbastro, Huesca, Spain

    Y. Harb

Authors
  1. J. P. Gisbert
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  2. A. Perez-Aisa
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  3. L. Rodrigo
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  4. J. Molina-Infante
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  17. A. G. McNicholl
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Consortia

On behalf of the H. pylori Study Group of the Spanish Gastroenterology Association

Corresponding author

Correspondence to J. P. Gisbert.

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Gisbert, J.P., Perez-Aisa, A., Rodrigo, L. et al. Third-Line Rescue Therapy with Bismuth-Containing Quadruple Regimen After Failure of Two Treatments (with Clarithromycin and Levofloxacin) for H. pylori Infection. Dig Dis Sci 59, 383–389 (2014). https://doi.org/10.1007/s10620-013-2900-x

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