Antonio Tursi1, Marilisa Franceschi2, Leonardo Allegretta3, Edoardo Savarino4, Rudi De Bastiani5, Walter Elisei6, Gianluca Baldassarre2, Antonio Ferronato2, Serena Scida7, Chiara Miraglia7, Antonio Penna8, Claudio Licci9, Giovanni Luca Rizzo10, Giuseppe Pranzo11, Claudio Cassieri12, Giovanni Brandimarte12, Marcello Picchio13, Francesco Di Mario7. 1. Gastroenterology Service, ASL BAT, Andria, Italy. 2. Digestive Endoscopy Unit, ULSS4 Alto Vicentino, Santorso, Italy. 3. Division of Gastroenterology, "S. Caterina Novella" Hospital, Galatina, Italy. 4. Division of Gastroenterology, Department of Surgery, Oncology and Gastroenterology, University of Padua, Padua, Italy. 5. Italian Association for Gastroenterology in Primary Care (GICA-CP), Feltre, Italy. 6. Division of Gastroenterology, Rome, Italy. 7. Department of Clinical and Experimental Medicine, Gastroenterology Unit, University of Parma, Parma, Italy. 8. Division of Gastroenterology, "S. Paolo" Hospital, Bari, Italy. 9. Private Practice Gastroenterologist, Monopoly, Italy. 10. "Salus" Home Care, Brindisi, Italy. 11. Digestive Endoscopy Service, "Valle d'Itria" Hospital, Martina Franca, Italy. 12. Division of Internal Medicine and Gastroenterology, "Cristo Re" Hospital, Rome, Italy. 13. Division of Surgery, "P. Colombo" Hospital, Rome, Italy.
Abstract
BACKGROUND: Our aims were to assess the real life effectiveness and safety of the new bismuth-containing quadruple therapy in a large population of patients infected by Helicobacter pylori. METHODS: Consecutive dyspeptic H. pylori-positive patients were enrolled, both naïve for treatment and already unsuccessfully treated. Patients were treated with Pylera® 3 capsules 4 times/daily plus omeprazole 20 mg or esomeprazole 40 mg 2 times/daily for 10 days. Eradication was confirmed using a urea-breath test (at least 30 days after the end of the treatment). Efficacy and safety were assessed. RESULTS: A total of 349 patients were treated. H. pylori eradication was achieved in 316 (90.5%, 95% CIs 80.8-1.0) patients in the intention-to-treat population, and in 93.5% (95% CIs 83.5-1.0) in the per-protocol population. No difference in the eradication rate was found between naïve and previously treated patients (91.3 vs. 90.0%, p = 0.901). Adverse events occurred in 55 patients (15.8%, 95% CIs 11.9-20.1). Five patients discontinued treatment: 2 patients suffered from severe abdominal pain, one patient from headache, one patient from diarrhea, and one patient from diffuse urticarial rush. CONCLUSIONS: Pylera® achieved a remarkable eradication rate in real life both as first treatment and as a rescue therapy, with a good safety profile.
BACKGROUND: Our aims were to assess the real life effectiveness and safety of the new bismuth-containing quadruple therapy in a large population of patients infected by Helicobacter pylori. METHODS: Consecutive dyspeptic H. pylori-positive patients were enrolled, both naïve for treatment and already unsuccessfully treated. Patients were treated with Pylera® 3 capsules 4 times/daily plus omeprazole 20 mg or esomeprazole 40 mg 2 times/daily for 10 days. Eradication was confirmed using a urea-breath test (at least 30 days after the end of the treatment). Efficacy and safety were assessed. RESULTS: A total of 349 patients were treated. H. pylori eradication was achieved in 316 (90.5%, 95% CIs 80.8-1.0) patients in the intention-to-treat population, and in 93.5% (95% CIs 83.5-1.0) in the per-protocol population. No difference in the eradication rate was found between naïve and previously treated patients (91.3 vs. 90.0%, p = 0.901). Adverse events occurred in 55 patients (15.8%, 95% CIs 11.9-20.1). Five patients discontinued treatment: 2 patients suffered from severe abdominal pain, one patient from headache, one patient from diarrhea, and one patient from diffuse urticarial rush. CONCLUSIONS: Pylera® achieved a remarkable eradication rate in real life both as first treatment and as a rescue therapy, with a good safety profile.
Authors: Estelle Guiard; Bénédicte Lelievre; Magali Rouyer; Frank Zerbib; Bertrand Diquet; Francis Mégraud; François Tison; Emmanuelle Bignon; Régis Lassalle; Cécile Droz-Perroteau; Nicholas Moore; Patrick Blin Journal: Drug Saf Date: 2019-08 Impact factor: 5.606
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