Empiric "Three-in-One" Bismuth Quadruple Therapy for Second-Line Eradication: An Intervention Study in Southern Italy.

Giuseppe Losurdo, Ilaria Lacavalla, Francesco Russo, Giuseppe Riezzo, Irene Vita Brescia, Maria Rendina, Enzo Ierardi, Alfredo Di Leo
Author Information
  1. Giuseppe Losurdo: Section of Gastroenterology, Department of Emergency and Organ Transplantation, University "Aldo Moro" of Bari, 70124 Bari, Italy. ORCID
  2. Ilaria Lacavalla: Section of Gastroenterology, Department of Emergency and Organ Transplantation, University "Aldo Moro" of Bari, 70124 Bari, Italy.
  3. Francesco Russo: Laboratory of Nutritional Pathophysiology, National Institute of Gastroenterology "S. de Bellis" Research Hospital, 70013 Castellana Grotte, Italy. ORCID
  4. Giuseppe Riezzo: Laboratory of Nutritional Pathophysiology, National Institute of Gastroenterology "S. de Bellis" Research Hospital, 70013 Castellana Grotte, Italy.
  5. Irene Vita Brescia: Section of Gastroenterology, Department of Emergency and Organ Transplantation, University "Aldo Moro" of Bari, 70124 Bari, Italy.
  6. Maria Rendina: Section of Gastroenterology, Department of Emergency and Organ Transplantation, University "Aldo Moro" of Bari, 70124 Bari, Italy.
  7. Enzo Ierardi: Section of Gastroenterology, Department of Emergency and Organ Transplantation, University "Aldo Moro" of Bari, 70124 Bari, Italy. ORCID
  8. Alfredo Di Leo: Section of Gastroenterology, Department of Emergency and Organ Transplantation, University "Aldo Moro" of Bari, 70124 Bari, Italy.

Abstract

The eradication of () may be difficult due to antibiotic resistance. Indeed, after one failure, a second-line therapy is needed and a bismuth containing quadruple therapy (BQT) with a three-in-one capsule formulation is becoming very popular. Therefore, we aimed to evaluate effectiveness and safety of BQT as a second-line therapy. We recruited consecutive patients with one therapy failure. For ten days patients received the three-in-one BQT Pylera therapy, in combination with a proton-pump inhibitor (PPI), decided at the choice of the investigator, at full dose bid. The eradication rate was calculated by intention-to-treat (ITT) and per-protocol (PP)analyses and 95% confidence intervals (CI) were calculated. Seventy-three patients were recruited, 41 females and 32 males (mean age 53.0±13.1 years). Fifty-five patients failed triple therapy with amoxicillin and clarithromycin and the remaining 18 received sequential therapy. Seventy-two patients consumed at least 90% of the capsules, while only one did not complete the therapy due to adverse events (nausea and diarrhea). By ITT analysis, BQT was successful in 62 subjects (eradication rate 84.9%, 95%CI 76.7-93.1%). By PP analysis, the eradication rate was 86.1% (95%CI 78.1-94.1%).Adverse events were observed in 14 subjects (20.5%).In conclusion, our report confirmed that BQT is effective as an empiric second-line regimen.

Keywords

References

  1. J Gastrointestin Liver Dis. 2014 Dec;23(4):367-70 [PMID: 25531993]
  2. Arch Intern Med. 1999 Oct 25;159(19):2312-6 [PMID: 10547171]
  3. World J Gastroenterol. 2018 Jan 7;24(1):139-149 [PMID: 29358890]
  4. Scand J Gastroenterol. 2018 Mar;53(3):265 [PMID: 29383955]
  5. Gastroenterology. 2021 Apr;160(5):1831-1841 [PMID: 33524402]
  6. Rev Esp Enferm Dig. 2021 May 5;: [PMID: 33947195]
  7. Helicobacter. 2019 Apr;24(2):e12565 [PMID: 30698318]
  8. Helicobacter. 2014 Sep;19 Suppl 1:27-31 [PMID: 25167942]
  9. Helicobacter. 2021 Dec;26(6):e12846 [PMID: 34414638]
  10. Panminerva Med. 2016 Dec;58(4):304-317 [PMID: 27716738]
  11. Lancet. 1997 Jan 25;349(9047):265-9 [PMID: 9014926]
  12. Helicobacter. 2017 Dec;22(6): [PMID: 29094477]
  13. Gastroenterology. 2016 Jul;151(1):51-69.e14 [PMID: 27102658]
  14. Antibiotics (Basel). 2020 May 31;9(6): [PMID: 32486473]
  15. Helicobacter. 2019 Apr;24(2):e12570 [PMID: 30767339]
  16. Antibiotics (Basel). 2021 Sep 01;10(9): [PMID: 34572643]
  17. Am J Gastroenterol. 2021 Jun 1;116(6):1220-1229 [PMID: 33840725]
  18. Gastroenterology. 2021 Sep;161(3):1071-1072 [PMID: 34048781]
  19. Antibiotics (Basel). 2020 Oct 21;9(10): [PMID: 33096925]
  20. Gut. 2017 Jan;66(1):6-30 [PMID: 27707777]
  21. Expert Rev Anti Infect Ther. 2018 Sep;16(9):679-687 [PMID: 30102559]
  22. BMJ Open Gastroenterol. 2020 Sep;7(1): [PMID: 32883715]
  23. Helicobacter. 2020 Aug;25(4):e12694 [PMID: 32314519]
  24. World J Gastroenterol. 2013 Dec 7;19(45):8168-80 [PMID: 24363506]
  25. World J Gastroenterol. 2019 Sep 14;25(34):5097-5104 [PMID: 31558859]
  26. Int J Cancer. 2015 Jan 15;136(2):487-90 [PMID: 24889903]
  27. United European Gastroenterol J. 2021 Feb;9(1):38-46 [PMID: 33176617]
  28. Gut. 2015 Sep;64(9):1353-67 [PMID: 26187502]
  29. Helicobacter. 2018 Aug;23(4):e12502 [PMID: 29924430]
  30. J Clin Gastroenterol. 2014 May-Jun;48(5):407-13 [PMID: 24296423]
  31. J Clin Med. 2021 Jul 24;10(15): [PMID: 34362057]
  32. Antibiotics (Basel). 2020 Dec 25;10(1): [PMID: 33375717]
  33. Gut. 2016 May;65(5):870-8 [PMID: 26848181]

Word Cloud

Created with Highcharts 10.0.0therapyeradicationBQTpatientsonesecond-linerate1%duefailurethree-in-onerecruitedreceivedcalculatedITTPPeventsanalysissubjects95%CImaydifficultantibioticresistanceIndeedneededbismuthcontainingquadruplecapsuleformulationbecomingpopularThereforeaimedevaluateeffectivenesssafetyconsecutivetendaysPyleracombinationproton-pumpinhibitorPPIdecidedchoiceinvestigatorfulldosebidintention-to-treatper-protocolanalyses95%confidenceintervalsCISeventy-three41females32malesmeanage530±131yearsFifty-fivefailedtripleamoxicillinclarithromycinremaining18sequentialSeventy-twoconsumedleast90%capsulescompleteadversenauseadiarrheasuccessful62849%767-9386781-94Adverseobserved14205%InconclusionreportconfirmedeffectiveempiricregimenEmpiric"Three-in-One"BismuthQuadrupleTherapySecond-LineEradication:InterventionStudySouthernItalyHelicobacterpyloriantibioticsgastritistetracycline

Similar Articles

Cited By