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. 2023 Feb;11(1):103-113.
doi: 10.1002/ueg2.12348. Epub 2022 Dec 23.

Effectiveness of first and second-line empirical treatment in Italy: Results of the European registry on Helicobacter pylori management

Luigi Gatta  1 , Olga P Nyssen  2 , Giulia Fiorini  3 , Ilaria Maria Saracino  3 , Matteo Pavoni  3 , Marco Romano  4 , Antonietta Gerarda Gravina  4 , Lucia Granata  4 , Rinaldo Pellicano  5 , Antonio Gasbarrini  6 , Alfredo Di Leo  7 , Giuseppe Losurdo  7 , Francesco Franceschi  8 , Gerardo Nardone  9 , Alba Rocco  9 , Maria Pina Dore  10 , Fabio Farinati  11 , Matteo Ghisa  11 , Massimo Bellini  12 , John Holton  13 , Ignasi Puig  14 , Dino Vaira  3 , Claudio Borghi  3 , Francis Mégraud  15 , Colm O'Morain  16 , Javier P Gisbert  2
Affiliations

Effectiveness of first and second-line empirical treatment in Italy: Results of the European registry on Helicobacter pylori management

Luigi Gatta et al. United European Gastroenterol J. 2023 Feb.

Abstract

Background and aims: The optimal management of naïve and not naïve Helicobacter pylori patients remains unclear. Therefore, it is essential to evaluate whether the actual clinical practice mirrors the indications suggested by the guidelines. This study aimed to assess the effectiveness and the safety of the empirical first- and second-line treatments prescribed to patients enroled at Italian centres participating in the European Registry on H. pylori Management (Hp-EuReg).

Methods: The Hp-EuReg is an international multicentre prospective non-interventional registry starting in 2013 aiming to evaluate the management of H. pylori infection by European gastroenterologists. Patients were registered in an e-CRF by AEG-REDCap. Variables assessed included demographics, previous eradication attempts, treatment regimen, effectiveness, and tolerance.

Results: Overall, 3723 patients from 2013 to February 2021 were included: 2996 and 727 received an empirical first- and second-line treatment, respectively. According to the modified ITT analysis, among the first-line regimens, only the bismuth quadruple therapy with three-in-one-single capsule (BQT-TSC), the concomitant, and the sequential treatment - all lasting 10 days - achieved an eradication rate >90%. Among the second-line regimens, only the 10-day BQT-TSC reported an effectiveness >90%. High-dose PPI twice daily also significantly increased the effectiveness of some therapies. The BQT-TSC was the regimen with the highest incidence of adverse events.

Conclusions: Only quadruple therapies lasting at least 10 days achieved over 90% eradication rates among the empirical first- and second-line regimens. It remains unclear whether high-dose PPI twice daily can improve the efficacy of quadruple treatment.

Keywords: H. pylori; Hp-EuReg; first-line treatment; proton pump inhibitor; second-line treatment.

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Conflict of interest statement

Olga P. Nyssen received research funding from Mayoly and Allergan; Antonio Gasbarrini served as consultant for Abbvie, Actial, AlphaSigma, Eisai, Gilead, Malesci, Maria Pina Dore, Sanofi, Takeda; Alfredo Di Leo served as a consultant for THD SpA; Gerardo Nardone received research grant from Sofar S.p.a and Alfasigma; Francis Mégraud received research grant from Allergan, bioMerieux, Mobidiag (to the institution), and as speaker from Biocodex and Mayoly; Claudio Borghi served as served as speaker, consultant, and advisory member for Servier, Novo‐Nordisk, Astra‐Zeneca, Sanofi; Javier P. Gisbert served as speaker, consultant, and advisory member for or received research funding from Mayoly, Allergan, Diasorin, Gebro Pharma, and Richen. All the remaining Authors have nothing to declare.

Figures

FIGURE 1
FIGURE 1
Evolution of first‐line treatments between 2013 and 2020. (a) Trends in the prescriptions of the five most frequently used first‐line treatments. (b) Trends in the duration of the five most frequently first‐line treatments prescribed
FIGURE 2
FIGURE 2
Evolution of second‐line treatments between 2013 and 2020. (a) Trends in the prescriptions of the five most frequently used second‐line treatments. (b) Trends in the duration of the five most frequently second‐line treatments prescribed
See this image and copyright information in PMC

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