Sandra Agudo-Fernández1, Ana González Blanco2. 1. Servicio de Gastroenterología, Hospital Rey Juan Carlos, Móstoles, Madrid, España. Electronic address: sandra.af.84@gmail.com. 2. Servicio de Gastroenterología, Hospital Rey Juan Carlos, Móstoles, Madrid, España.
Abstract
OBJECTIVE: The resistance of Helicobacter pylori to antibiotics is a growing problem in Spain and eradication rates must be improved. The new Spanish consensus considers quadruple therapy with bismuth as first- or second-line therapy. This study evaluated the use of Pylera® in real-life clinical practice. PATIENTS AND METHODS: A cross-sectional descriptive study was conducted to evaluate the eradication rate of Helicobacter pylori in patients treated with Pylera® between March and September 2016. Patients (naïve or with previous treatment failure) were treated for 10 days. Eradication was confirmed using a breath test with urea 30 days or more after treatment. In addition, demographic, clinical-analytical and treatment-related data were collected. RESULTS: A total of 185 patients were included (51.6±16.19 years); 63.8% were women and 9.2% had a family history of gastric cancer. The most frequent indication was dyspepsia (55.1%). Approximately 57.8% received Pylera® as first-line therapy, while 95.7% received Pylera® in combination with omeprazole. A first-line eradication rate of 78.15% was observed in the intention-to-treat population (86.6% per protocol). There were no statistically significant differences between naïve patients and those previously treated. Nine patients abandoned the treatment (4.9%), 7 due to mild side effects and 2 due to incorrect dosing. CONCLUSIONS: Pylera® has acceptable eradication rates in first- and second-line therapy and shows a suitable safety profile.
OBJECTIVE: The resistance of Helicobacter pylori to antibiotics is a growing problem in Spain and eradication rates must be improved. The new Spanish consensus considers quadruple therapy with bismuth as first- or second-line therapy. This study evaluated the use of Pylera® in real-life clinical practice. PATIENTS AND METHODS: A cross-sectional descriptive study was conducted to evaluate the eradication rate of Helicobacter pylori in patients treated with Pylera® between March and September 2016. Patients (naïve or with previous treatment failure) were treated for 10 days. Eradication was confirmed using a breath test with urea 30 days or more after treatment. In addition, demographic, clinical-analytical and treatment-related data were collected. RESULTS: A total of 185 patients were included (51.6±16.19 years); 63.8% were women and 9.2% had a family history of gastric cancer. The most frequent indication was dyspepsia (55.1%). Approximately 57.8% received Pylera® as first-line therapy, while 95.7% received Pylera® in combination with omeprazole. A first-line eradication rate of 78.15% was observed in the intention-to-treat population (86.6% per protocol). There were no statistically significant differences between naïve patients and those previously treated. Nine patients abandoned the treatment (4.9%), 7 due to mild side effects and 2 due to incorrect dosing. CONCLUSIONS: Pylera® has acceptable eradication rates in first- and second-line therapy and shows a suitable safety profile.
Authors: Olga P Nyssen; Angeles Perez-Aisa; Manuel Castro-Fernandez; Rinaldo Pellicano; Jose M Huguet; Luis Rodrigo; Juan Ortuñ; Blas J Gomez-Rodriguez; Ricardo M Pinto; Miguel Areia; Monica Perona; Oscar Nuñez; Marco Romano; Antonietta G Gravina; Liliana Pozzati; Miguel Fernandez-Bermejo; Marino Venerito; Peter Malfertheiner; Luis Fernanadez-Salazar; Antonio Gasbarrini; Dino Vaira; Ignasi Puig; Francis Megraud; Colm O'Morain; Javier P Gisbert Journal: United European Gastroenterol J Date: 2021-02-11 Impact factor: 4.623