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

Adult Amoxicillin Anti-Bacterial Agents / therapeutic use Bismuth Clarithromycin / therapeutic use Drug Therapy, Combination Helicobacter Infections / drug therapy Helicobacter pylori Humans Levofloxacin Moxifloxacin / therapeutic use Penicillins / adverse effects Prospective Studies Proton Pump Inhibitors Quinolones / therapeutic use Registries Tetracycline / therapeutic use

Bismuth Clarithromycin Helicobacter pylori Levofloxacin Rescue

Journal

Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association

ISSN: 1542-7714

Titre abrégé: Clin Gastroenterol Hepatol

Pays: United States

ID NLM: 101160775

Informations de publication

Date de publication:
10 2022

Historique:

received: 05 11 2021

accepted: 14 12 2021

pubmed: 27 12 2021

medline: 28 9 2022

entrez: 26 12 2021

Statut: ppublish

Résumé

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. 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. 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. 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.

Sections du résumé

BACKGROUND & AIMS

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.

Identifiants

DOI: 10.1016/j.cgh.2021.12.025 PMID: 34954341

pubmed: 34954341

pii: S1542-3565(21)01349-5

doi: 10.1016/j.cgh.2021.12.025

pii:

doi:

Substances chimiques

Anti-Bacterial Agents 0

Penicillins 0

Proton Pump Inhibitors 0

Quinolones 0

Levofloxacin 6GNT3Y5LMF

Amoxicillin 804826J2HU

Tetracycline F8VB5M810T

Clarithromycin H1250JIK0A

Bismuth U015TT5I8H

Moxifloxacin U188XYD42P

Banques de données

ClinicalTrials.gov

['NCT02328131']

Types de publication

Journal Article Multicenter Study Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

Pagination

2243-2257

Investigateurs

Giulia Fiorinni (G)

Ilaria Maria Saracino (IM)

Manuel Pabon Carrasco (MP)

Alma Keco Huerga (AK)

Enrique Alfaro Almajano (EA)

Samuel Jesus Martinez Dominguez (SJ)

Horacio Alonso Galan (HA)

Benito Velayos (B)

Carmen Dueñas Sadornil (CD)

Jose Maria Botargues Bote (JM)

Pedro Luis Gonzalez-Cordero (PL)

Miguel Areia (M)

Blas Jose Gomez Rodriguez (BJ)

Rinaldo Pellicano (R)

Óscar Nuñez (Ó)

Francesco Franceschi (F)

Sergey Alekseenko (S)

Monica Perona (M)

Rustam Abdulkhakov (R)

Manuel Dominguez-Cajal (M)

Pedro Almela Notari (PA)

Judith Gomez Camarero (JG)

Manuel Jimenez Moreno (MJ)

Alicia Algaba (A)

Fernando Bermejo (F)

Jose Maria Botargues Bote (JM)

Javier Tejedor Tejada (JT)

Elida Oblitas Susanibar (EO)

Doron Boltin (D)

Sotirios Georgopoulos (S)

Colm OMorain (C)

Asghar Qasim (A)

Ian Beales (I)

Natalia Bakulina (N)

Galina Fadeenko (G)

Peter Malfertheiner (P)

Rosa Rosania (R)

Tatiana Ilchishina (T)

Pavel Bogomolov (P)

Igor Bakulin (I)

Oleg Zaytsev (O)

Antonietta Gerarda Gravina (AG)

Marco Romano (M)

Alfredo Di Leo (A)

Giuseppe Losurdo (G)

Ludmila Grigorieva (L)

Pedro Delgado Guillena (PD)

Marinko Marusic (M)

Dragan Jurcic (D)

Natalia Nikolaevna Dekhnich (NN)

Eduardo Iyo (E)

Luisa Carmen de la Peña Negro (LC)

Natalia Baryshnikova (N)

Natalia Bakanova (N)

Halis Simsek (H)

Cem Simsek (C)

Oleksiy Gridnyev (O)

Miguel Fernandez-Bermejo (M)

Teresa Angueira (T)

Rafael Ruiz-Zorrilla Lopez (R)

Barbara Gomez (B)

Mila Kovacheva-Slavova (M)

Adi Lahat (A)

Javier Alcedo (J)

Ana Campillo (A)

Liya Nikolaevna Belousova (LN)

Ramon Pajares Villarroya (RP)

Neven Ljubicic (N)

Marko Nikolic (M)

Jesús M González-Santiago (JM)

Diego Burgos Santamaría (DB)

Anna Pakhomova (A)

Izabela Sekulic-Spasic (I)

Matteo Ghisa (M)

Fabio Farinati (F)

Sabir Irfan Sagdati (SI)

Nikola Panic (N)

Frederic Heluwaert (F)

Edurne Amorena (E)

Leticia Moreira (L)

Gloria Fernandez Esparrach (GF)

Ekaterina Yuryevna Plotnikova (EY)

Michal Kukla (M)

Victor Kamburov (V)

Luis Javier Lamuela Calvo (LJ)

Ivan Rankovic (I)

Antonio Cuadrado Lavín (AC)

Yolanda Arguedas Lazaro (YA)

Victor Gonzalez Carrera Agnieszka Dobrowolska (VG)

Piotr Eder (P)

Alla Kononova (A)

Commentaires et corrections

Type : CommentIn