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Adverse Event Profile During the Treatment of Helicobacter pylori: A Real-World Experience of 22,000 Patients From the European Registry on H. pylori Management (Hp-EuReg).
Nyssen, Olga P; Perez-Aisa, Angeles; Tepes, Bojan; Castro-Fernandez, Manuel; Kupcinskas, Juozas; Jonaitis, Laimas; Bujanda, Luis; Lucendo, Alfredo; Jurecic, Natasa Brglez; Perez-Lasala, Jorge; Shvets, Oleg; Fadeenko, Galina; Huguet, Jose M; Kikec, Zdenki; Bordin, Dmitry; Voynovan, Irina; Leja, Marcis; Machado, Jose Carlos; Areia, Miguel; Fernandez-Salazar, Luis; Rodrigo, Luis; Alekseenko, Sergey; Barrio, Jesus; Ortuño, Juan; Perona, Monica; Vologzhanina, Liudmila; Romero, Pilar Mata; Zaytsev, Oleg; Rokkas, Theodore; Georgopoulos, Sotirios; Pellicano, Rinaldo; Buzas, Gyorgy M; Modolell, Ines; Gomez Rodriguez, Blas Jose; Simsek, Ilkay; Simsek, Cem; Lafuente, Marina Roldan; Ilchishina, Tatiana; Camarero, Judith Gomez; Dominguez-Cajal, Manuel; Ntouli, Vassiliki; Dekhnich, Natalia Nikolaevna; Phull, Perminder; Nuñez, Oscar; Lerang, Frode; Venerito, Marino; Heluwaert, Frederic; Tonkic, Ante; Caldas, Maria; Puig, Ignasi.
Affiliation
  • Nyssen OP; 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.
  • Perez-Aisa A; Gastroenterology Unit, Agencia Sanitaria Costa del Sol, Marbella, Red de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC), Málaga, Spain.
  • Tepes B; Gastroenterology Unit, AM DC Rogaska, Rogaska Slatina, Slovenia.
  • Castro-Fernandez M; Gastroenterology Unit, Hospital de Valme, Sevilla, Spain.
  • Kupcinskas J; Gastroenterology Unit, Lithuanian University of Health Sciences, Kaunas, Lithuania.
  • Jonaitis L; Gastroenterology Unit, Lithuanian University of Health Sciences, Kaunas, Lithuania.
  • Bujanda L; 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.
  • Lucendo A; Gastroenterology Unit, Hospital de Tomelloso, Ciudad Real, Spain.
  • Jurecic NB; Gastroenterology Unit, Diagnostic Center Bled, Slovenia.
  • Perez-Lasala J; Gastroenterology Unit, HM Sanchinarro, Madrid, Spain.
  • Shvets O; Gastroenterology Unit, Internal Diseases Department No. 1, National Medical University named after O.O. Bogomolets, Kyiv, Ukraine.
  • Fadeenko G; Gastroenterology Unit, National Ukrainian Academy of Medical Sciences, Ukraine.
  • Huguet JM; Gastroenterology Unit, Consorci Hospital General Universitari Valencia, Spain.
  • Kikec Z; Gastroenterology Unit, Hospital Slovenj Gradec, Slovenj Gradec, Slovenia.
  • Bordin D; Gastroenterology Unit, A. S. Loginov Moscow Clinical Scientific Center, Moscow, Russia.
  • Voynovan I; Gastroenterology Unit, Department of Outpatient Therapy and Family Medicine, Tver State Medical University, Tver, Russia.
  • Leja M; Gastroenterology Unit, Department of Propaedeutic of Internal diseases and Gastroenterology, A.I. Yevdokimov Moscow State University of Medicine and Dentistry, Moscow, Russia.
  • Machado JC; Gastroenterology Unit, A. S. Loginov Moscow Clinical Scientific Center, Moscow, Russia.
  • Areia M; Gastroenterology Unit, Digestive Diseases Center GASTRO, Riga, Latvia.
  • Fernandez-Salazar L; 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.
  • Rodrigo L; Gastroenterology Unit, Portuguese Oncology Institute of Coimbra, Portugal.
  • Alekseenko S; Gastroenterology Unit, Hospital Clínico Universitario Valladolid, Spain.
  • Barrio J; Gastroenterology Unit, Hospital Universitario Central de Asturias, Oviedo, Spain.
  • Ortuño J; Gastroenterology Unit, Far Eastern State Medical University Khabarovsk, Russia.
  • Perona M; Gastroenterology Unit, Hospital Rio Hortega, Valladolid, Spain.
  • Vologzhanina L; Gastroenterology Unit, Hospital Universitari I Politècnic La Fe Valencia, Spain.
  • Romero PM; Gastroenterology Unit, Hospital Quiron Marbella, Spain.
  • Zaytsev O; Gastroenterology Unit, Gastrocentr, Perm, Russia.
  • Rokkas T; Gastroenterology Unit, Hospital San Pedro de Alcántara, Cáceres, Spain.
  • Georgopoulos S; Gastroenterology Unit, First Clinical Medical Center Kovrov, Russia.
  • Pellicano R; Gastroenterology Unit, Henry Dunant Hospital, Athens, Greece.
  • Buzas GM; Gastroenterology Unit, Athens Medical Center, Paleo Faliron General Hospital Athens, Greece.
  • Modolell I; Gastroenterology Unit, Molinette Hospital Turin, Italy.
  • Gomez Rodriguez BJ; Gastroenterology Unit, Ferencváros Policlinic, Budapest, Hungary.
  • Simsek I; Gastroenterology Unit, Consorci Sanitari Terrassa, Spain.
  • Simsek C; Gastroenterology Unit, Hospital Universitario Virgen Macarena, Sevilla, Spain.
  • Lafuente MR; Gastroenterology Unit, Dokuz Eylul University School of Medicine, Izmir, Turkey.
  • Ilchishina T; Gastroenterology Unit, Hacettepe University Ankara, Turkey.
  • Camarero JG; Gastroenterology Unit, Hospital General Universitario de Castellon, Spain.
  • Dominguez-Cajal M; Gastroenterology Unit, SM-clinic, Saint-Petersburg, Russia.
  • Ntouli V; Gastroenterology Unit, Hospital Universitario de Burgos, Spain.
  • Dekhnich NN; Gastroenterology Unit, Hospital San Jorge Huesca, Spain.
  • Phull P; Gastroenterology Unit, General Hospital Pireaus, Greece.
  • Nuñez O; Gastroenterology Unit, Institute of Antimicrobial Chemotherapy, Smolensk, Russia.
  • Lerang F; Gastroenterology Unit, Aberdeen Royal Infirmary Aberdeen, United Kingdom.
  • Venerito M; Gastroenterology Unit, Hospital Universitario Sanitas La Moraleja, Madrid, Spain.
  • Heluwaert F; Gastroenterology Unit, Medical Department, Central Hospital Ostfold, Fredrikstad, Norway.
  • Tonkic A; Gastroenterology Unit, Department of Gastroenterology, Hepatology and Infectious Diseases, Otto-von-Guericke University Hospital, Magdeburg, Germany.
  • Caldas M; Gastroenterology Unit, Center Hospitalier Annecy Genvois, Pringy, France.
  • Puig I; Gastroenterology Unit, University Hospital of Split, School of Medicine, University of Split, Croatia.
Am J Gastroenterol ; 116(6): 1220-1229, 2021 06 01.
Article in En | MEDLINE | ID: mdl-33840725
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.
Subject(s)

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Bismuth / Helicobacter Infections / Drug-Related Side Effects and Adverse Reactions / Proton Pump Inhibitors / Anti-Bacterial Agents Type of study: Clinical_trials / Incidence_studies / Prognostic_studies Limits: Female / Humans / Male / Middle aged Country/Region as subject: Europa Language: En Journal: Am J Gastroenterol Year: 2021 Document type: Article Affiliation country:

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Bismuth / Helicobacter Infections / Drug-Related Side Effects and Adverse Reactions / Proton Pump Inhibitors / Anti-Bacterial Agents Type of study: Clinical_trials / Incidence_studies / Prognostic_studies Limits: Female / Humans / Male / Middle aged Country/Region as subject: Europa Language: En Journal: Am J Gastroenterol Year: 2021 Document type: Article Affiliation country: