Olga P Nyssen1, Angeles Perez-Aisa2, Bojan Tepes3, Manuel Castro-Fernandez4, Juozas Kupcinskas5, Laimas Jonaitis5, Luis Bujanda6, Alfredo Lucendo7, Natasa Brglez Jurecic8, Jorge Perez-Lasala9, Oleg Shvets10, Galina Fadeenko11, Jose M Huguet12, Zdenki Kikec13, Dmitry Bordin14,15,16, Irina Voynovan14, Marcis Leja17, Jose Carlos Machado18, Miguel Areia19, Luis Fernandez-Salazar20, Luis Rodrigo21, Sergey Alekseenko22, Jesus Barrio23, Juan Ortuño24, Monica Perona25, Liudmila Vologzhanina26, Pilar Mata Romero27, Oleg Zaytsev28, Theodore Rokkas29, Sotirios Georgopoulos30, Rinaldo Pellicano31, Gyorgy M Buzas32, Ines Modolell33, Blas Jose Gomez Rodriguez34, Ilkay Simsek35, Cem Simsek36, Marina Roldan Lafuente37, Tatiana Ilchishina38, Judith Gomez Camarero39, Manuel Dominguez-Cajal40, Vassiliki Ntouli41, Natalia Nikolaevna Dekhnich42, Perminder Phull43, Oscar Nuñez44, Frode Lerang45, Marino Venerito46, Frederic Heluwaert47, Ante Tonkic48, Maria Caldas1, Ignasi Puig49, Francis Megraud50, Colm O'Morain51, Javier P Gisbert1. 1. Gastroenterology Unit, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-IP), Universidad Autónoma de Madrid, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain. 2. Gastroenterology Unit, Agencia Sanitaria Costa del Sol, Marbella, Red de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC), Málaga, Spain. 3. Gastroenterology Unit, AM DC Rogaska, Rogaska Slatina, Slovenia. 4. Gastroenterology Unit, Hospital de Valme, Sevilla, Spain. 5. Gastroenterology Unit, Lithuanian University of Health Sciences, Kaunas, Lithuania. 6. Gastroenterology Unit, Hospital Donostia/Instituto Biodonostia, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Universidad del País Vasco (UPV/EHU), San Sebastián, Spain. 7. Gastroenterology Unit, Hospital de Tomelloso, Ciudad Real, Spain. 8. Gastroenterology Unit, Diagnostic Center Bled, Slovenia. 9. Gastroenterology Unit, HM Sanchinarro, Madrid, Spain. 10. Gastroenterology Unit, Internal Diseases Department No. 1, National Medical University named after O.O. Bogomolets, Kyiv, Ukraine. 11. Gastroenterology Unit, National Ukrainian Academy of Medical Sciences, Ukraine. 12. Gastroenterology Unit, Consorci Hospital General Universitari Valencia, Spain. 13. Gastroenterology Unit, Hospital Slovenj Gradec, Slovenj Gradec, Slovenia. 14. Gastroenterology Unit, A. S. Loginov Moscow Clinical Scientific Center, Moscow, Russia. 15. Gastroenterology Unit, Department of Outpatient Therapy and Family Medicine, Tver State Medical University, Tver, Russia. 16. Gastroenterology Unit, Department of Propaedeutic of Internal diseases and Gastroenterology, A.I. Yevdokimov Moscow State University of Medicine and Dentistry, Moscow, Russia. 17. Gastroenterology Unit, Digestive Diseases Center GASTRO, Riga, Latvia. 18. Gastroenterology Unit, Instituto de Investigação e Inovação em Saúde, Universidade do Porto, and Ipatimup-Institute of Molecular Pathology and Immunology of the University of Porto, Portugal. 19. Gastroenterology Unit, Portuguese Oncology Institute of Coimbra, Portugal. 20. Gastroenterology Unit, Hospital Clínico Universitario Valladolid, Spain. 21. Gastroenterology Unit, Hospital Universitario Central de Asturias, Oviedo, Spain. 22. Gastroenterology Unit, Far Eastern State Medical University Khabarovsk, Russia. 23. Gastroenterology Unit, Hospital Rio Hortega, Valladolid, Spain. 24. Gastroenterology Unit, Hospital Universitari I Politècnic La Fe Valencia, Spain. 25. Gastroenterology Unit, Hospital Quiron Marbella, Spain. 26. Gastroenterology Unit, Gastrocentr, Perm, Russia. 27. Gastroenterology Unit, Hospital San Pedro de Alcántara, Cáceres, Spain. 28. Gastroenterology Unit, First Clinical Medical Center Kovrov, Russia. 29. Gastroenterology Unit, Henry Dunant Hospital, Athens, Greece. 30. Gastroenterology Unit, Athens Medical Center, Paleo Faliron General Hospital Athens, Greece. 31. Gastroenterology Unit, Molinette Hospital Turin, Italy. 32. Gastroenterology Unit, Ferencváros Policlinic, Budapest, Hungary. 33. Gastroenterology Unit, Consorci Sanitari Terrassa, Spain. 34. Gastroenterology Unit, Hospital Universitario Virgen Macarena, Sevilla, Spain. 35. Gastroenterology Unit, Dokuz Eylul University School of Medicine, Izmir, Turkey. 36. Gastroenterology Unit, Hacettepe University Ankara, Turkey. 37. Gastroenterology Unit, Hospital General Universitario de Castellon, Spain. 38. Gastroenterology Unit, SM-clinic, Saint-Petersburg, Russia. 39. Gastroenterology Unit, Hospital Universitario de Burgos, Spain. 40. Gastroenterology Unit, Hospital San Jorge Huesca, Spain. 41. Gastroenterology Unit, General Hospital Pireaus, Greece. 42. Gastroenterology Unit, Institute of Antimicrobial Chemotherapy, Smolensk, Russia. 43. Gastroenterology Unit, Aberdeen Royal Infirmary Aberdeen, United Kingdom. 44. Gastroenterology Unit, Hospital Universitario Sanitas La Moraleja, Madrid, Spain. 45. Gastroenterology Unit, Medical Department, Central Hospital Ostfold, Fredrikstad, Norway. 46. Gastroenterology Unit, Department of Gastroenterology, Hepatology and Infectious Diseases, Otto-von-Guericke University Hospital, Magdeburg, Germany. 47. Gastroenterology Unit, Center Hospitalier Annecy Genvois, Pringy, France. 48. Gastroenterology Unit, University Hospital of Split, School of Medicine, University of Split, Croatia. 49. Gastroenterology Unit, Althaia Xarxa Assistencial Universitària de Manresa and Universitat de Vic-Universitat Central de Catalunya (UVicUCC), Manresa, Spain. 50. Gastroenterology Unit, Laboratoire de Bactériologie, Hôpital Pellegrin, Bordeaux, France. 51. Gastroenterology Unit, Department of Clinical Medicine, Trinity College Dublin, Ireland.
Abstract
INTRODUCTION: The safety of Helicobacter pylori eradication treatments and to what extent adverse events (AEs) influence therapeutic compliance in clinical practice are hardly known. Our aim was to assess the frequency, type, intensity, and duration of AEs, and their impact on compliance, for the most frequently used treatments in the "European Registry on Helicobacter pylori management." METHODS: Systematic prospective noninterventional registry of the clinical practice of European gastroenterologists (27 countries, 300 investigators) on the management of H. pylori infection in routine clinical practice. All prescribed eradication treatments and their corresponding safety profile were recorded. AEs were classified depending on the intensity of symptoms as mild/moderate/severe and as serious AEs. All data were subject to quality control. RESULTS: The different treatments prescribed to 22,492 patients caused at least 1 AE in 23% of the cases; the classic bismuth-based quadruple therapy was the worst tolerated (37% of AEs). Taste disturbance (7%), diarrhea (7%), nausea (6%), and abdominal pain (3%) were the most frequent AEs. The majority of AEs were mild (57%), 6% were severe, and only 0.08% were serious, with an average duration of 7 days. The treatment compliance rate was 97%. Only 1.3% of the patients discontinued treatment due to AEs. Longer treatment durations were significantly associated with a higher incidence of AEs in standard triple, concomitant, bismuth quadruple, and levofloxacin triple or quadruple therapies. DISCUSSION: Helicobacter pylori eradication treatment frequently induces AEs, although they are usually mild and of limited duration. Their appearance does not interfere significantly with treatment compliance.
INTRODUCTION: The safety of Helicobacter pylori eradication treatments and to what extent adverse events (AEs) influence therapeutic compliance in clinical practice are hardly known. Our aim was to assess the frequency, type, intensity, and duration of AEs, and their impact on compliance, for the most frequently used treatments in the "European Registry on Helicobacter pylori management." METHODS: Systematic prospective noninterventional registry of the clinical practice of European gastroenterologists (27 countries, 300 investigators) on the management of H. pyloriinfection in routine clinical practice. All prescribed eradication treatments and their corresponding safety profile were recorded. AEs were classified depending on the intensity of symptoms as mild/moderate/severe and as serious AEs. All data were subject to quality control. RESULTS: The different treatments prescribed to 22,492 patients caused at least 1 AE in 23% of the cases; the classic bismuth-based quadruple therapy was the worst tolerated (37% of AEs). Taste disturbance (7%), diarrhea (7%), nausea (6%), and abdominal pain (3%) were the most frequent AEs. The majority of AEs were mild (57%), 6% were severe, and only 0.08% were serious, with an average duration of 7 days. The treatment compliance rate was 97%. Only 1.3% of the patients discontinued treatment due to AEs. Longer treatment durations were significantly associated with a higher incidence of AEs in standard triple, concomitant, bismuth quadruple, and levofloxacin triple or quadruple therapies. DISCUSSION: Helicobacter pylori eradication treatment frequently induces AEs, although they are usually mild and of limited duration. Their appearance does not interfere significantly with treatment compliance.
Authors: Luis Fernández-Salazar; Ana Campillo; Luis Rodrigo; Ángeles Pérez-Aisa; Jesús M González-Santiago; Xavier Segarra Ortega; Maja Denkovski; Natasa Brglez Jurecic; Luis Bujanda; Blas José Gómez Rodríguez; Juan Ortuño; Sotirios Georgopoulos; Laimas Jonaitis; Ignasi Puig; Olga P Nyssen; Francis Megraud; Colm O'Morain; Javier P Gisbert Journal: J Clin Med Date: 2022-06-20 Impact factor: 4.964
Authors: Giuseppe Losurdo; Ilaria Lacavalla; Francesco Russo; Giuseppe Riezzo; Irene Vita Brescia; Maria Rendina; Enzo Ierardi; Alfredo Di Leo Journal: Antibiotics (Basel) Date: 2022-01-10
Authors: Olga P Nyssen; Dino Vaira; Ilaria Maria Saracino; Giulia Fiorini; María Caldas; Luis Bujanda; Rinaldo Pellicano; Alma Keco-Huerga; Manuel Pabón-Carrasco; Elida Oblitas Susanibar; Alfredo Di Leo; Giuseppe Losurdo; Ángeles Pérez-Aísa; Antonio Gasbarrini; Doron Boltin; Sinead Smith; Perminder Phull; Theodore Rokkas; Dominique Lamarque; Anna Cano-Català; Ignasi Puig; Francis Mégraud; Colm O'Morain; Javier P Gisbert Journal: J Clin Med Date: 2022-03-16 Impact factor: 4.241