Background The recommended schedule for single capsule bismuth quadruple therapy (scBQT, Pylera) includes a proton pump inhibitor (PPI) two times a day and three scBQT capsules four times a day. Four times a day treatments are inconvenient and reduce adherence. In contrast, adherence improves with three times a day schedules. In clinical practice, many gastroenterologists use four capsule scBQT three times a day. However, the effectiveness and safety of this latter approach remain uncertain.
Aim To assess the effectiveness and safety of scBQT administered three times a day in the patients included in the European Registry on Helicobacter pylori Management (Hp-EuReg).
Methods All Spanish adult patients registered in the Asociación Española de Gastroenterología Research Electronic Data Capture (REDCap) database from June 2013 to March 2021 receiving 10-day scBQT were analysed. Modified intention-to-treat effectiveness, adherence and the safety of scBQT given three times a day were calculated and compared with the four times a day schedule. A multivariate analysis was performed to determine independent factors predicting cure of the infection.
Results Of the 3712 cases, 2516 (68%) were four times a day and 1196 (32%) three times a day. Mean age was 51 years, 63% were women and 15% had a peptic ulcer. The three times a day schedule showed significantly better overall cure rates than four times a day (1047/1112, 94%; 95% CI 92.7 to 95.6 vs 2207/2423, 91%; 95% CI 89.9 to 92.2, respectively, p=0.002). Adherence and safety data were similar for both regimens. In the multivariate analysis, three times a day dosage, first-line therapy, use of standard or high-dose PPIs and adherence over 90% were significantly associated with cure of the infection.
Conclusions ScBQT prescribed three times a day was more effective than the traditional four times a day schedule. No differences were observed in treatment adherence or safety.
- helicobacter pylori
Data availability statement
Data are available upon reasonable request.
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XC and JPG are joint senior authors.
Twitter @Ana_Campillo, @CalvetXMD
ÁP-A and OPN contributed equally.
Contributors ÁP-A: planned and coordinated the study; extracted, analysed, summarised and interpreted the data; wrote the first draft and approved the submitted manuscript. XC: principal Investigator and guarantor of the study, planned and coordinated the study; extracted, analysed, summarised and interpreted the data; wrote the first draft and approved the submitted manuscript. OPN: planned and coordinated the study; extracted, analysed, summarised and interpreted the data; wrote the first draft; scientific director and member of the project’s scientific committee; planned and coordinated the study; designed and programmed the electronic case report form; analysed the data; critically reviewed the manuscript drafts and approved the submitted manuscript. LR, AJL, BJGR, JO, MP, JMH, ON, LF-S, JB, ÁL, EI, PMR, MF-B, BG, JG-C, LJL, AC, LdlP-N, MDC, LB, DB-S, FB, VG-C, RP, PAN, JT-T, MP, IJ, YAL, AC-L, IP-M, EA, JMG-S, TA, VF, SJM-D, MP-C, BV, AA, CR, EAA, MC-F, NA and PSS: acted as recruiters, critically reviewed the manuscript drafts and approved the submitted manuscript. AC-C: technical project manager, critically reviewed the manuscript drafts and approved the submitted manuscript. NG-M: critically reviewed the manuscript drafts and approved the submitted manuscript. OPN, LM, FM and CO: members of the project’s scientific committee, critically reviewed the manuscript drafts and approved the submitted manuscript. JPG: principal investigator of the project and member of the project’s scientific committee, obtained funding, designed the protocol and planned the study, acted as recruiter, analysed and interpreted the data, critically reviewed the manuscript drafts and approved the final submitted manuscript.
Funding This project was promoted and funded by the European Helicobacter and Microbiota Study Group, the Spanish Association of Gastroenterology and the Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas.
Competing interests XC has received research grants and fees for lectures from Allergan. JPG has served as speaker, consultant and advisory member for or has received research funding from Mayoly Spindler, Allergan, Diasorin, Gebro Pharma and Richen. OPN received research funding from Allergan and Mayoly Spindler. Dr Bordin served as a lecturer for Astellas, AstraZeneca, KRKA, and Abbott. FM is a consultant for PHATHOM and DaVoltera and has received grants from Allergan, bioMerieux and Mobidiag. The remaining authors declare no conflict of interest.
Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Provenance and peer review Not commissioned; externally peer reviewed.