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. 2020 Dec 25;10(1):13.
doi: 10.3390/antibiotics10010013.

European Registry on Helicobacter pylori Management: Effectiveness of First and Second-Line Treatment in Spain

María Caldas  1 , Ángeles Pérez-Aisa  2 , Manuel Castro-Fernández  3 , Luis Bujanda  4 , Alfredo J Lucendo  5 , Luis Rodrigo  6 , Jose M Huguet  7 , Jorge Pérez-Lasala  8 , Javier Molina-Infante  9 , Jesús Barrio  10 , Luis Fernández-Salazar  11 , Ángel Lanas  12 , Mónica Perona  13 , Manuel Domínguez-Cajal  14 , Juan Ortuño  15 , Blas José Gómez-Rodríguez  16 , Pedro Almela  17 , Josep María Botargués  18 , Óscar Núñez  19 , Inés Modolell  20 , Judith Gómez  21 , Rafael Ruiz-Zorrilla  22 , Cristóbal De la Coba  23 , Alain Huerta  24 , Eduardo Iyo  25 , Liliana Pozzati  26 , Rosario Antón  27 , Mercé Barenys  28 , Teresa Angueira  5 , Miguel Fernández-Bermejo  29 , Ana Campillo  30 , Javier Alcedo  31 , Ramón Pajares-Villaroya  32 , Marianela Mego  33 , Fernando Bermejo  34 , José Luis Dominguez-Jiménez  35 , Llúcia Titó  36 , Nuria Fernández  2 , Manuel Pabón-Carrasco  37 , Ángel Cosme  4 , Pilar Mata-Romero  9 , Noelia Alcaide  11 , Inés Ariño  12 , Tommaso Di Maira  15 , Ana Garre  1 , Ignasi Puig  38 , Olga P Nyssen  1 , Francis Megraud  39 , Colm O'Morain  40 , Javier P Gisbert  1 ; Hp-EuReg Investigators
Collaborators, Affiliations

European Registry on Helicobacter pylori Management: Effectiveness of First and Second-Line Treatment in Spain

María Caldas et al. Antibiotics (Basel). .

Abstract

The management of Helicobacter pylori infection has to rely on previous local effectiveness due to the geographical variability of antibiotic resistance. The aim of this study was to evaluate the effectiveness of first and second-line H. pylori treatment in Spain, where the empirical prescription is recommended. A multicentre prospective non-interventional registry of the clinical practice of European gastroenterologists concerning H. pylori infection (Hp-EuReg) was developed, including patients from 2013 until June 2019. Effectiveness was evaluated descriptively and through a multivariate analysis concerning age, gender, presence of ulcer, proton-pump inhibitor (PPI) dose, therapy duration and compliance. Overall, 53 Spanish hospitals were included, and 10,267 patients received a first-line therapy. The best results were obtained with the 10-day bismuth single-capsule therapy (95% cure rate by intention-to-treat) and with both the 14-day bismuth-clarithromycin quadruple (PPI-bismuth-clarithromycin-amoxicillin, 91%) and the 14-day non-bismuth quadruple concomitant (PPI-clarithromycin-amoxicillin-metronidazole, 92%) therapies. Second-line therapies were prescribed to 2448 patients, with most-effective therapies being the triple quinolone (PPI-amoxicillin-levofloxacin/moxifloxacin) and the bismuth-levofloxacin quadruple schemes (PPI-bismuth-levofloxacin-amoxicillin) prescribed for 14 days (92%, 89% and 90% effectiveness, respectively), and the bismuth single-capsule (10 days, 88.5%). Compliance, longer duration and higher acid inhibition were associated with higher effectiveness. "Optimized" H. pylori therapies achieve over 90% success in Spain.

Keywords: Helicobacter pylori; Spain; first-line; second-line; treatment.

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Conflict of interest statement

Ángeles Pérez-Aisa has served as a speaker for Allergan. Olga P. Nyssen has received a research grant from Allergan. Francis Megraud received honoraria from Phathom (advisory meeting) and Biocodex (lecture fees) and commercial research funding from Aptalis. Javier P. Gisbert has served as speaker, consultant and advisory member for or has received research funding from Mayoly, Allergan and Diasorin. The rest of the authors have no disclosures.

Figures

Figure 1
Figure 1
Prescription trends in first- (A) Type of therapy; (B) Duration of therapy; (C) Dose of PPI and second-line (D) Type of therapy; (E) Duration of therapy; (F) Dose of PPI treatment. PPI: proton-pump inhibitor, C: clarithromycin, A: amoxicillin, M: metronidazole, Single-capsule: three-in-one single capsule, Bi: bismuth, Conc: concomitant administration, Seq: sequential administration, L: levofloxacin, Mx: Moxifloxacin, Low: ≈20 mg omeprazole equivalents b.i.d., Standard: ≈40 mg omeprazole equivalents b.i.d., High: ≈60 mg omeprazole equivalents b.i.d.
Figure 2
Figure 2
Flowchart of the Spanish patients participating in the Hp-EuReg. N: number of patients included. ITT: intention-to-treat analysis. mITT: modified intention-to-treat analysis. PP: per protocol analysis.
See this image and copyright information in PMC

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