Empirical Second-Line Therapy in 5000 Patients of the European
Registry on Helicobacter pylori Management (Hp-EuReg)

J 2022

Empirical Second-Line Therapy in 5000 Patients of the European Registry on Helicobacter pylori Management (Hp-EuReg)

NYSSEN, O. P., D. VAIRA, Á. PÉREZ AÍSA, L. RODRIGO, M. CASTRO-FERNANDEZ et. al.

Basic information

Original name

Empirical Second-Line Therapy in 5000 Patients of the European Registry on Helicobacter pylori Management (Hp-EuReg)

Authors

NYSSEN, O. P. (guarantor), D. VAIRA, Á. PÉREZ AÍSA, L. RODRIGO, M. CASTRO-FERNANDEZ, L. JONAITIS, B. TEPES, L. VOLOGZHANINA, M. CALDAS, A. LANAS, A. J. LUCENDO, L. BUJANDA, J. ORTUÑO, J. BARRIO, J. M. HUGUET, I. VOYNOVAN, J. P. LASALA, A. S. SARSENBAEVA, L. FERNANDEZ-SALAZAR, J. MOLINA-INFANTE, N. B. JURECIC, M. AREIA, A. GASBARRINI, J. KUPČINSKAS, D. BORDIN, R. MARCOS-PINTO, F. LERAND, M. LEJA, G. M. BUZAS, Y. NIV, T. ROKKAS, P. PHULL, S. SMITH, O. SHVETS, M. VENERITO, V. MILIVOJEVIC, I. SIMSEK, V. LAMY, P. BYTZER, L. BOYANOVA, Lumír KUNOVSKÝ (203 Czech Republic, belonging to the institution), C. BEGLINGER, M. DOULBERIS, W. MARLICZ, A. GOLDIS, A. TONKIĆ, L. CAPELLE, I. PUIG, F. MEGRAUD, C. O. MORAIN and J. P. GISBERT

Edition

Clinical Gastroenterology and Hepatology, New York, Elsevier, 2022, 1542-3565

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30219 Gastroenterology and hepatology

Country of publisher

United States of America

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

URL

Impact factor

Impact factor: 12.600

RIV identification code

RIV/00216224:14110/22:00125477

Organization unit

Faculty of Medicine

DOI

http://dx.doi.org/10.1016/j.cgh.2021.12.025

UT WoS

000899945100018

Keywords in English

Bismuth; Helicobacter pylori; Clarithromycin; Levofloxacin; Rescue

Abstract

V originále

Background & Aims After a first Helicobacter pylori eradication attempt, approximately 20% of patients will remain infected. The aim of the current study was to assess the effectiveness and safety of second-line empiric treatment in Europe. Methods This international, multicenter, prospective, non-interventional registry aimed to evaluate the decisions and outcomes of H pylori management by European gastroenterologists. All infected adult cases with a previous eradication treatment attempt were registered with the Spanish Association of Gastroenterology–Research Electronic Data Capture until February 2021. Patients allergic to penicillin and those who received susceptibility-guided therapy were excluded. Data monitoring was performed to ensure data quality. Results Overall, 5055 patients received empiric second-line treatment. Triple therapy with amoxicillin and levofloxacin was prescribed most commonly (33%). The overall effectiveness was 82% by modified intention-to-treat analysis and 83% in the per-protocol population. After failure of first-line clarithromycin-containing treatment, optimal eradication (>90%) was obtained with moxifloxacin-containing triple therapy or levofloxacin-containing quadruple therapy (with bismuth). In patients receiving triple therapy containing levofloxacin or moxifloxacin, and levofloxacin–bismuth quadruple treatment, cure rates were optimized with 14-day regimens using high doses of proton pump inhibitors. However, 3-in-1 single capsule or levofloxacin–bismuth quadruple therapy produced reliable eradication rates regardless of proton pump inhibitor dose, duration of therapy, or previous first-line treatment. The overall incidence of adverse events was 28%, and most (85%) were mild. Three patients developed serious adverse events (0.3%) requiring hospitalization. Conclusions Empiric second-line regimens including 14-day quinolone triple therapies, 14-day levofloxacin–bismuth quadruple therapy, 14-day tetracycline–bismuth classic quadruple therapy, and 10-day bismuth quadruple therapy (as a single capsule) provided optimal effectiveness. However, many other second-line treatments evaluated reported low eradication rates.

Citovat

NYSSEN, O. P., D. VAIRA, Á. PÉREZ AÍSA, L. RODRIGO, M. CASTRO-FERNANDEZ, L. JONAITIS, B. TEPES, L. VOLOGZHANINA, M. CALDAS, A. LANAS, A. J. LUCENDO, L. BUJANDA, J. ORTUÑO, J. BARRIO, J. M. HUGUET, I. VOYNOVAN, J. P. LASALA, A. S. SARSENBAEVA, L. FERNANDEZ-SALAZAR, J. MOLINA-INFANTE, N. B. JURECIC, M. AREIA, A. GASBARRINI, J. KUPČINSKAS, D. BORDIN, R. MARCOS-PINTO, F. LERAND, M. LEJA, G. M. BUZAS, Y. NIV, T. ROKKAS, P. PHULL, S. SMITH, O. SHVETS, M. VENERITO, V. MILIVOJEVIC, I. SIMSEK, V. LAMY, P. BYTZER, L. BOYANOVA, Lumír KUNOVSKÝ, C. BEGLINGER, M. DOULBERIS, W. MARLICZ, A. GOLDIS, A. TONKIĆ, L. CAPELLE, I. PUIG, F. MEGRAUD, C. O. MORAIN and J. P. GISBERT. Empirical Second-Line Therapy in 5000 Patients of the European Registry on Helicobacter pylori Management (Hp-EuReg). Clinical Gastroenterology and Hepatology. New York: Elsevier, 2022, vol. 20, No 10, p. 2243-2257. ISSN 1542-3565. Available from: https://dx.doi.org/10.1016/j.cgh.2021.12.025.

@article{1839438,
   author = {Nyssen, O. P. and Vaira, D. and Pérez Aísa, Á. and Rodrigo, L. and CastroandFernandez, M. and Jonaitis, L. and Tepes, B. and Vologzhanina, L. and Caldas, M. and Lanas, A. and Lucendo, A. J. and Bujanda, L. and Ortuño, J. and Barrio, J. and Huguet, J. M. and Voynovan, I. and Lasala, J. P. and Sarsenbaeva, A. S. and FernandezandSalazar, L. and MolinaandInfante, J. and Jurecic, N. B. and Areia, M. and Gasbarrini, A. and Kupčinskas, J. and Bordin, D. and MarcosandPinto, R. and Lerand, F. and Leja, M. and Buzas, G. M. and Niv, Y. and Rokkas, T. and Phull, P. and Smith, S. and Shvets, O. and Venerito, M. and Milivojevic, V. and Simsek, I. and Lamy, V. and Bytzer, P. and Boyanova, L. and Kunovský, Lumír and Beglinger, C. and Doulberis, M. and Marlicz, W. and Goldis, A. and Tonkić, A. and Capelle, L. and Puig, I. and Megraud, F. and Morain, C. O. and Gisbert, J. P.},
   article_location = {New York},
   article_number = {10},
   doi = {http://dx.doi.org/10.1016/j.cgh.2021.12.025},
   keywords = {Bismuth; Helicobacter pylori; Clarithromycin; Levofloxacin; Rescue},
   language = {eng},
   issn = {1542-3565},
   journal = {Clinical Gastroenterology and Hepatology},
   title = {Empirical Second-Line Therapy in 5000 Patients of the European Registry on Helicobacter pylori Management (Hp-EuReg)},
   url = {https://www.sciencedirect.com/science/article/abs/pii/S1542356521013495?via%3Dihub},
   volume = {20},
   year = {2022}
}

TY  - JOUR
ID  - 1839438
AU  - Nyssen, O. P. - Vaira, D. - Pérez Aísa, Á. - Rodrigo, L. - Castro-Fernandez, M. - Jonaitis, L. - Tepes, B. - Vologzhanina, L. - Caldas, M. - Lanas, A. - Lucendo, A. J. - Bujanda, L. - Ortuño, J. - Barrio, J. - Huguet, J. M. - Voynovan, I. - Lasala, J. P. - Sarsenbaeva, A. S. - Fernandez-Salazar, L. - Molina-Infante, J. - Jurecic, N. B. - Areia, M. - Gasbarrini, A. - Kupčinskas, J. - Bordin, D. - Marcos-Pinto, R. - Lerand, F. - Leja, M. - Buzas, G. M. - Niv, Y. - Rokkas, T. - Phull, P. - Smith, S. - Shvets, O. - Venerito, M. - Milivojevic, V. - Simsek, I. - Lamy, V. - Bytzer, P. - Boyanova, L. - Kunovský, Lumír - Beglinger, C. - Doulberis, M. - Marlicz, W. - Goldis, A. - Tonkić, A. - Capelle, L. - Puig, I. - Megraud, F. - Morain, C. O. - Gisbert, J. P.
PY  - 2022
TI  - Empirical Second-Line Therapy in 5000 Patients of the European Registry on Helicobacter pylori Management (Hp-EuReg)
JF  - Clinical Gastroenterology and Hepatology
VL  - 20
IS  - 10
SP  - 2243-2257
EP  - 2243-2257
PB  - Elsevier
SN  - 15423565
KW  - Bismuth
KW  - Helicobacter pylori
KW  - Clarithromycin
KW  - Levofloxacin
KW  - Rescue
UR  - https://www.sciencedirect.com/science/article/abs/pii/S1542356521013495?via%3Dihub
N2  - Background & Aims After a first Helicobacter pylori eradication attempt, approximately 20% of patients will remain infected. The aim of the current study was to assess the effectiveness and safety of second-line empiric treatment in Europe. Methods This international, multicenter, prospective, non-interventional registry aimed to evaluate the decisions and outcomes of H pylori management by European gastroenterologists. All infected adult cases with a previous eradication treatment attempt were registered with the Spanish Association of Gastroenterology–Research Electronic Data Capture until February 2021. Patients allergic to penicillin and those who received susceptibility-guided therapy were excluded. Data monitoring was performed to ensure data quality. Results Overall, 5055 patients received empiric second-line treatment. Triple therapy with amoxicillin and levofloxacin was prescribed most commonly (33%). The overall effectiveness was 82% by modified intention-to-treat analysis and 83% in the per-protocol population. After failure of first-line clarithromycin-containing treatment, optimal eradication (>90%) was obtained with moxifloxacin-containing triple therapy or levofloxacin-containing quadruple therapy (with bismuth). In patients receiving triple therapy containing levofloxacin or moxifloxacin, and levofloxacin–bismuth quadruple treatment, cure rates were optimized with 14-day regimens using high doses of proton pump inhibitors. However, 3-in-1 single capsule or levofloxacin–bismuth quadruple therapy produced reliable eradication rates regardless of proton pump inhibitor dose, duration of therapy, or previous first-line treatment. The overall incidence of adverse events was 28%, and most (85%) were mild. Three patients developed serious adverse events (0.3%) requiring hospitalization. Conclusions Empiric second-line regimens including 14-day quinolone triple therapies, 14-day levofloxacin–bismuth quadruple therapy, 14-day tetracycline–bismuth classic quadruple therapy, and 10-day bismuth quadruple therapy (as a single capsule) provided optimal effectiveness. However, many other second-line treatments evaluated reported low eradication rates.
ER  -

NYSSEN, O. P., D. VAIRA, Á. PÉREZ AÍSA, L. RODRIGO, M. CASTRO-FERNANDEZ, L. JONAITIS, B. TEPES, L. VOLOGZHANINA, M. CALDAS, A. LANAS, A. J. LUCENDO, L. BUJANDA, J. ORTUÑO, J. BARRIO, J. M. HUGUET, I. VOYNOVAN, J. P. LASALA, A. S. SARSENBAEVA, L. FERNANDEZ-SALAZAR, J. MOLINA-INFANTE, N. B. JURECIC, M. AREIA, A. GASBARRINI, J. KUPČINSKAS, D. BORDIN, R. MARCOS-PINTO, F. LERAND, M. LEJA, G. M. BUZAS, Y. NIV, T. ROKKAS, P. PHULL, S. SMITH, O. SHVETS, M. VENERITO, V. MILIVOJEVIC, I. SIMSEK, V. LAMY, P. BYTZER, L. BOYANOVA, Lumír KUNOVSKÝ, C. BEGLINGER, M. DOULBERIS, W. MARLICZ, A. GOLDIS, A. TONKI$\backslash$'C, L. CAPELLE, I. PUIG, F. MEGRAUD, C. O. MORAIN and J. P. GISBERT. Empirical Second-Line Therapy in 5000 Patients of the European Registry on Helicobacter pylori Management (Hp-EuReg). \textit{Clinical Gastroenterology and Hepatology}. New York: Elsevier, 2022, vol.~20, No~10, p.~2243-2257. ISSN~1542-3565. Available from: https://dx.doi.org/10.1016/j.cgh.2021.12.025.

Detailed Information on Publication Record