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

Research output: Contribution to journal › Journal article › Research › peer-review

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Empirical Second-Line Therapy in 5000 Patients of the European Registry on Helicobacter pylori Management (Hp-EuReg). / Nyssen, Olga P.; Vaira, Dino; Pérez Aísa, Ángeles; Rodrigo, Luis; Castro-Fernandez, Manuel; Jonaitis, Laimas; Tepes, Bojan; Vologzhanina, Liudmila; Caldas, María; Lanas, Angel; Lucendo, Alfredo J.; Bujanda, Luis; Ortuño, Juan; Barrio, Jesús; Huguet, Jose M.; Voynovan, Irina; Lasala, Jorge Perez; Sarsenbaeva, Aiman Silkanovna; Fernandez-Salazar, Luis; Molina-Infante, Javier; Jurecic, Natasa Brglez; Areia, Miguel; Gasbarrini, Antonio; Kupčinskas, Juozas; Bordin, Dmitry; Marcos-Pinto, Ricardo; Lerang, Frode; Leja, Marcis; Buzas, Gyorgy M.; Niv, Yaron; Rokkas, Theodore; Phull, Perminder; Smith, Sinead; Shvets, Oleg; Venerito, Marino; Milivojevic, Vladimir; Simsek, Ilkay; Lamy, Vincent; Bytzer, Peter; Boyanova, Lyudmila; Kunovský, Lumír; Beglinger, Christoph; Doulberis, Michael; Marlicz, Wojciech; Goldis, Adrian; Tonkić, Ante; Capelle, Lisette; Puig, Ignasi; Megraud, Francis; Morain, Colm O’; European Registry on Helicobacter pylori Management Hp-EuReg Investigators.

In: Clinical Gastroenterology and Hepatology, Vol. 20, No. 10, 2022, p. 2243-2257.

Research output: Contribution to journal › Journal article › Research › peer-review

Harvard

Nyssen, OP, Vaira, D, Pérez Aísa, Á, Rodrigo, L, Castro-Fernandez, M, Jonaitis, L, Tepes, B, Vologzhanina, L, Caldas, M, Lanas, A, Lucendo, AJ, Bujanda, L, Ortuño, J, Barrio, J, Huguet, JM, Voynovan, I, Lasala, JP, Sarsenbaeva, AS, Fernandez-Salazar, L, Molina-Infante, J, Jurecic, NB, Areia, M, Gasbarrini, A, Kupčinskas, J, Bordin, D, Marcos-Pinto, R, Lerang, F, Leja, M, Buzas, GM, Niv, Y, Rokkas, T, Phull, P, Smith, S, Shvets, O, Venerito, M, Milivojevic, V, Simsek, I, Lamy, V, Bytzer, P, Boyanova, L, Kunovský, L, Beglinger, C, Doulberis, M, Marlicz, W, Goldis, A, Tonkić, A, Capelle, L, Puig, I, Megraud, F, Morain, CO & European Registry on Helicobacter pylori Management Hp-EuReg Investigators 2022, 'Empirical Second-Line Therapy in 5000 Patients of the European Registry on Helicobacter pylori Management (Hp-EuReg)', Clinical Gastroenterology and Hepatology, vol. 20, no. 10, pp. 2243-2257. https://doi.org/10.1016/j.cgh.2021.12.025

APA

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., ... European Registry on Helicobacter pylori Management Hp-EuReg Investigators (2022). Empirical Second-Line Therapy in 5000 Patients of the European Registry on Helicobacter pylori Management (Hp-EuReg). Clinical Gastroenterology and Hepatology, 20(10), 2243-2257. https://doi.org/10.1016/j.cgh.2021.12.025

Vancouver

Nyssen OP, Vaira D, Pérez Aísa Á, Rodrigo L, Castro-Fernandez M, Jonaitis L et al. Empirical Second-Line Therapy in 5000 Patients of the European Registry on Helicobacter pylori Management (Hp-EuReg). Clinical Gastroenterology and Hepatology. 2022;20(10):2243-2257. https://doi.org/10.1016/j.cgh.2021.12.025

Author

Nyssen, Olga P. ; Vaira, Dino ; Pérez Aísa, Ángeles ; Rodrigo, Luis ; Castro-Fernandez, Manuel ; Jonaitis, Laimas ; Tepes, Bojan ; Vologzhanina, Liudmila ; Caldas, María ; Lanas, Angel ; Lucendo, Alfredo J. ; Bujanda, Luis ; Ortuño, Juan ; Barrio, Jesús ; Huguet, Jose M. ; Voynovan, Irina ; Lasala, Jorge Perez ; Sarsenbaeva, Aiman Silkanovna ; Fernandez-Salazar, Luis ; Molina-Infante, Javier ; Jurecic, Natasa Brglez ; Areia, Miguel ; Gasbarrini, Antonio ; Kupčinskas, Juozas ; Bordin, Dmitry ; Marcos-Pinto, Ricardo ; Lerang, Frode ; Leja, Marcis ; Buzas, Gyorgy M. ; Niv, Yaron ; Rokkas, Theodore ; Phull, Perminder ; Smith, Sinead ; Shvets, Oleg ; Venerito, Marino ; Milivojevic, Vladimir ; Simsek, Ilkay ; Lamy, Vincent ; Bytzer, Peter ; Boyanova, Lyudmila ; Kunovský, Lumír ; Beglinger, Christoph ; Doulberis, Michael ; Marlicz, Wojciech ; Goldis, Adrian ; Tonkić, Ante ; Capelle, Lisette ; Puig, Ignasi ; Megraud, Francis ; Morain, Colm O’ ; European Registry on Helicobacter pylori Management Hp-EuReg Investigators. / Empirical Second-Line Therapy in 5000 Patients of the European Registry on Helicobacter pylori Management (Hp-EuReg). In: Clinical Gastroenterology and Hepatology. 2022 ; Vol. 20, No. 10. pp. 2243-2257.

Bibtex

@article{8a3ba433e6e848139dd8dbde6e02af4b,

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

abstract = "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. ClincialTrials.gov number: NCT02328131.",

keywords = "Bismuth, Clarithromycin, Helicobacter pylori, Levofloxacin, Rescue",

author = "Nyssen, {Olga P.} and Dino Vaira and {P{\'e}rez A{\'i}sa}, {\'A}ngeles and Luis Rodrigo and Manuel Castro-Fernandez and Laimas Jonaitis and Bojan Tepes and Liudmila Vologzhanina and Mar{\'i}a Caldas and Angel Lanas and Lucendo, {Alfredo J.} and Luis Bujanda and Juan Ortu{\~n}o and Jes{\'u}s Barrio and Huguet, {Jose M.} and Irina Voynovan and Lasala, {Jorge Perez} and Sarsenbaeva, {Aiman Silkanovna} and Luis Fernandez-Salazar and Javier Molina-Infante and Jurecic, {Natasa Brglez} and Miguel Areia and Antonio Gasbarrini and Juozas Kup{\v c}inskas and Dmitry Bordin and Ricardo Marcos-Pinto and Frode Lerang and Marcis Leja and Buzas, {Gyorgy M.} and Yaron Niv and Theodore Rokkas and Perminder Phull and Sinead Smith and Oleg Shvets and Marino Venerito and Vladimir Milivojevic and Ilkay Simsek and Vincent Lamy and Peter Bytzer and Lyudmila Boyanova and Lum{\'i}r Kunovsk{\'y} and Christoph Beglinger and Michael Doulberis and Wojciech Marlicz and Adrian Goldis and Ante Tonki{\'c} and Lisette Capelle and Ignasi Puig and Francis Megraud and Morain, {Colm O{\textquoteright}} and {European Registry on Helicobacter pylori Management Hp-EuReg Investigators}",

note = "Publisher Copyright: {\textcopyright} 2021 AGA Institute",

year = "2022",

doi = "10.1016/j.cgh.2021.12.025",

language = "English",

volume = "20",

pages = "2243--2257",

journal = "Clinical Gastroenterology and Hepatology",

issn = "1542-3565",

publisher = "W.B.Saunders Co.",

number = "10",

}

RIS

TY - JOUR

T1 - Empirical Second-Line Therapy in 5000 Patients of the European Registry on Helicobacter pylori Management (Hp-EuReg)

AU - Nyssen, Olga P.

AU - Vaira, Dino

AU - Pérez Aísa, Ángeles

AU - Rodrigo, Luis

AU - Castro-Fernandez, Manuel

AU - Jonaitis, Laimas

AU - Tepes, Bojan

AU - Vologzhanina, Liudmila

AU - Caldas, María

AU - Lanas, Angel

AU - Lucendo, Alfredo J.

AU - Bujanda, Luis

AU - Ortuño, Juan

AU - Barrio, Jesús

AU - Huguet, Jose M.

AU - Voynovan, Irina

AU - Lasala, Jorge Perez

AU - Sarsenbaeva, Aiman Silkanovna

AU - Fernandez-Salazar, Luis

AU - Molina-Infante, Javier

AU - Jurecic, Natasa Brglez

AU - Areia, Miguel

AU - Gasbarrini, Antonio

AU - Kupčinskas, Juozas

AU - Bordin, Dmitry

AU - Marcos-Pinto, Ricardo

AU - Lerang, Frode

AU - Leja, Marcis

AU - Buzas, Gyorgy M.

AU - Niv, Yaron

AU - Rokkas, Theodore

AU - Phull, Perminder

AU - Smith, Sinead

AU - Shvets, Oleg

AU - Venerito, Marino

AU - Milivojevic, Vladimir

AU - Simsek, Ilkay

AU - Lamy, Vincent

AU - Bytzer, Peter

AU - Boyanova, Lyudmila

AU - Kunovský, Lumír

AU - Beglinger, Christoph

AU - Doulberis, Michael

AU - Marlicz, Wojciech

AU - Goldis, Adrian

AU - Tonkić, Ante

AU - Capelle, Lisette

AU - Puig, Ignasi

AU - Megraud, Francis

AU - Morain, Colm O’

AU - European Registry on Helicobacter pylori Management Hp-EuReg Investigators

PY - 2022

Y1 - 2022

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. ClincialTrials.gov number: NCT02328131.

AB - 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. ClincialTrials.gov number: NCT02328131.

KW - Bismuth

KW - Clarithromycin

KW - Helicobacter pylori

KW - Levofloxacin

KW - Rescue

U2 - 10.1016/j.cgh.2021.12.025

DO - 10.1016/j.cgh.2021.12.025

M3 - Journal article

C2 - 34954341

AN - SCOPUS:85125914877

VL - 20

SP - 2243

EP - 2257

JO - Clinical Gastroenterology and Hepatology

JF - Clinical Gastroenterology and Hepatology

SN - 1542-3565

IS - 10

ER -

ID: 305397069