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, noninterventional 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.

Empirical Second-Line Therapy in 5,000 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; Lerand, 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'; Gisbert, Javier P. - In: CLINICAL GASTROENTEROLOGY AND HEPATOLOGY. - ISSN 1542-3565. - ELETTRONICO. - 20:10(2022), pp. 2243-2257. [10.1016/j.cgh.2021.12.025]

Empirical Second-Line Therapy in 5,000 Patients of the European Registry on Helicobacter pylori Management (Hp-EuReg)

Vaira, Dino;
2022

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, noninterventional 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.
2022
Empirical Second-Line Therapy in 5,000 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; Lerand, 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'; Gisbert, Javier P. - In: CLINICAL GASTROENTEROLOGY AND HEPATOLOGY. - ISSN 1542-3565. - ELETTRONICO. - 20:10(2022), pp. 2243-2257. [10.1016/j.cgh.2021.12.025]
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; Lerand, 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'; Gisbert, Javier P
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