PMID- 24126798 OWN - NLM STAT- MEDLINE DCOM- 20140410 LR - 20211021 IS - 1573-2568 (Electronic) IS - 0163-2116 (Linking) VI - 59 IP - 2 DP - 2014 Feb TI - Third-line rescue therapy with bismuth-containing quadruple regimen after failure of two treatments (with clarithromycin and levofloxacin) for H. pylori infection. PG - 383-9 LID - 10.1007/s10620-013-2900-x [doi] AB - 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 (13)C-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. FAU - Gisbert, J P AU - Gisbert JP AD - Gastroenterology Unit, Hospital Universitario de La Princesa and Instituto de Investigacion Sanitaria Princesa (IP), Playa de Mojacar 29. Urb. Bonanza., 28669, Boadilla del Monte, Madrid, Spain, gisbert@meditex.es. FAU - Perez-Aisa, A AU - Perez-Aisa A FAU - Rodrigo, L AU - Rodrigo L FAU - Molina-Infante, J AU - Molina-Infante J FAU - Modolell, I AU - Modolell I FAU - Bermejo, F AU - Bermejo F FAU - Castro-Fernandez, M AU - Castro-Fernandez M FAU - Anton, R AU - Anton R FAU - Sacristan, B AU - Sacristan B FAU - Cosme, A AU - Cosme A FAU - Barrio, J AU - Barrio J FAU - Harb, Y AU - Harb Y FAU - Gonzalez-Barcenas, M AU - Gonzalez-Barcenas M FAU - Fernandez-Bermejo, M AU - Fernandez-Bermejo M FAU - Algaba, A AU - Algaba A FAU - Marin, A C AU - Marin AC FAU - McNicholl, A G AU - McNicholl AG CN - H. pylori Study Group of the Spanish Gastroenterology Association LA - eng PT - Clinical Trial PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't DEP - 20131015 PL - United States TA - Dig Dis Sci JT - Digestive diseases and sciences JID - 7902782 RN - 0 (Anti-Bacterial Agents) RN - 0 (Organometallic Compounds) RN - 0 (Proton Pump Inhibitors) RN - 140QMO216E (Metronidazole) RN - 6GNT3Y5LMF (Levofloxacin) RN - 804826J2HU (Amoxicillin) RN - F8VB5M810T (Tetracycline) RN - H1250JIK0A (Clarithromycin) RN - HS813P8QPX (bismuth tripotassium dicitrate) SB - IM MH - Adult MH - Amoxicillin/therapeutic use MH - Anti-Bacterial Agents/adverse effects/*therapeutic use MH - Clarithromycin/*therapeutic use MH - Drug Therapy, Combination MH - Female MH - Helicobacter Infections/diagnosis/*drug therapy/microbiology MH - Helicobacter pylori/*drug effects/isolation & purification MH - Humans MH - Levofloxacin/*therapeutic use MH - Male MH - Metronidazole/therapeutic use MH - Middle Aged MH - Organometallic Compounds/adverse effects/*therapeutic use MH - Prospective Studies MH - Proton Pump Inhibitors/therapeutic use MH - *Salvage Therapy MH - Spain MH - Surveys and Questionnaires MH - Tetracycline/therapeutic use MH - Time Factors MH - Treatment Failure EDAT- 2013/10/16 06:00 MHDA- 2014/04/11 06:00 CRDT- 2013/10/16 06:00 PHST- 2013/07/08 00:00 [received] PHST- 2013/09/25 00:00 [accepted] PHST- 2013/10/16 06:00 [entrez] PHST- 2013/10/16 06:00 [pubmed] PHST- 2014/04/11 06:00 [medline] AID - 10.1007/s10620-013-2900-x [doi] PST - ppublish SO - Dig Dis Sci. 2014 Feb;59(2):383-9. doi: 10.1007/s10620-013-2900-x. Epub 2013 Oct 15.