PMID- 33840725
OWN - NLM
STAT- MEDLINE
DCOM- 20210630
LR  - 20240229
IS  - 1572-0241 (Electronic)
IS  - 0002-9270 (Linking)
VI  - 116
IP  - 6
DP  - 2021 Jun 1
TI  - 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).
PG  - 1220-1229
LID - 10.14309/ajg.0000000000001246 [doi]
AB  - 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.
CI  - Copyright (c) 2021 by The American College of Gastroenterology.
FAU - Nyssen, Olga P
AU  - Nyssen OP
AD  - Gastroenterology Unit, Hospital Universitario de La Princesa, Instituto de 
      Investigacion Sanitaria Princesa (IIS-IP), Universidad Autonoma de Madrid, Centro 
      de Investigacion Biomedica en Red de Enfermedades Hepaticas y Digestivas 
      (CIBEREHD), Madrid, Spain.
FAU - Perez-Aisa, Angeles
AU  - Perez-Aisa A
AD  - Gastroenterology Unit, Agencia Sanitaria Costa del Sol, Marbella, Red de 
      Investigacion en Servicios de Salud en Enfermedades Cronicas (REDISSEC), Malaga, 
      Spain.
FAU - Tepes, Bojan
AU  - Tepes B
AD  - Gastroenterology Unit, AM DC Rogaska, Rogaska Slatina, Slovenia.
FAU - Castro-Fernandez, Manuel
AU  - Castro-Fernandez M
AD  - Gastroenterology Unit, Hospital de Valme, Sevilla, Spain.
FAU - Kupcinskas, Juozas
AU  - Kupcinskas J
AD  - Gastroenterology Unit, Lithuanian University of Health Sciences, Kaunas, 
      Lithuania.
FAU - Jonaitis, Laimas
AU  - Jonaitis L
AD  - Gastroenterology Unit, Lithuanian University of Health Sciences, Kaunas, 
      Lithuania.
FAU - Bujanda, Luis
AU  - Bujanda L
AD  - Gastroenterology Unit, Hospital Donostia/Instituto Biodonostia, Centro de 
      Investigacion Biomedica en Red de Enfermedades Hepaticas y Digestivas (CIBERehd), 
      Universidad del Pais Vasco (UPV/EHU), San Sebastian, Spain.
FAU - Lucendo, Alfredo
AU  - Lucendo A
AD  - Gastroenterology Unit, Hospital de Tomelloso, Ciudad Real, Spain.
FAU - Jurecic, Natasa Brglez
AU  - Jurecic NB
AD  - Gastroenterology Unit, Diagnostic Center Bled, Slovenia.
FAU - Perez-Lasala, Jorge
AU  - Perez-Lasala J
AD  - Gastroenterology Unit, HM Sanchinarro, Madrid, Spain.
FAU - Shvets, Oleg
AU  - Shvets O
AD  - Gastroenterology Unit, Internal Diseases Department No. 1, National Medical 
      University named after O.O. Bogomolets, Kyiv, Ukraine.
FAU - Fadeenko, Galina
AU  - Fadeenko G
AD  - Gastroenterology Unit, National Ukrainian Academy of Medical Sciences, Ukraine.
FAU - Huguet, Jose M
AU  - Huguet JM
AD  - Gastroenterology Unit, Consorci Hospital General Universitari Valencia, Spain.
FAU - Kikec, Zdenki
AU  - Kikec Z
AD  - Gastroenterology Unit, Hospital Slovenj Gradec, Slovenj Gradec, Slovenia.
FAU - Bordin, Dmitry
AU  - Bordin D
AD  - Gastroenterology Unit, A. S. Loginov Moscow Clinical Scientific Center, Moscow, 
      Russia.
AD  - Gastroenterology Unit, Department of Outpatient Therapy and Family Medicine, Tver 
      State Medical University, Tver, Russia.
AD  - Gastroenterology Unit, Department of Propaedeutic of Internal diseases and 
      Gastroenterology, A.I. Yevdokimov Moscow State University of Medicine and 
      Dentistry, Moscow, Russia.
FAU - Voynovan, Irina
AU  - Voynovan I
AD  - Gastroenterology Unit, A. S. Loginov Moscow Clinical Scientific Center, Moscow, 
      Russia.
FAU - Leja, Marcis
AU  - Leja M
AD  - Gastroenterology Unit, Digestive Diseases Center GASTRO, Riga, Latvia.
FAU - Machado, Jose Carlos
AU  - Machado JC
AD  - Gastroenterology Unit, Instituto de Investigacao e Inovacao em Saude, 
      Universidade do Porto, and Ipatimup-Institute of Molecular Pathology and 
      Immunology of the University of Porto, Portugal.
FAU - Areia, Miguel
AU  - Areia M
AD  - Gastroenterology Unit, Portuguese Oncology Institute of Coimbra, Portugal.
FAU - Fernandez-Salazar, Luis
AU  - Fernandez-Salazar L
AD  - Gastroenterology Unit, Hospital Clinico Universitario Valladolid, Spain.
FAU - Rodrigo, Luis
AU  - Rodrigo L
AD  - Gastroenterology Unit, Hospital Universitario Central de Asturias, Oviedo, Spain.
FAU - Alekseenko, Sergey
AU  - Alekseenko S
AD  - Gastroenterology Unit, Far Eastern State Medical University Khabarovsk, Russia.
FAU - Barrio, Jesus
AU  - Barrio J
AD  - Gastroenterology Unit, Hospital Rio Hortega, Valladolid, Spain.
FAU - Ortuno, Juan
AU  - Ortuno J
AD  - Gastroenterology Unit, Hospital Universitari I Politecnic La Fe Valencia, Spain.
FAU - Perona, Monica
AU  - Perona M
AD  - Gastroenterology Unit, Hospital Quiron Marbella, Spain.
FAU - Vologzhanina, Liudmila
AU  - Vologzhanina L
AD  - Gastroenterology Unit, Gastrocentr, Perm, Russia.
FAU - Romero, Pilar Mata
AU  - Romero PM
AD  - Gastroenterology Unit, Hospital San Pedro de Alcantara, Caceres, Spain.
FAU - Zaytsev, Oleg
AU  - Zaytsev O
AD  - Gastroenterology Unit, First Clinical Medical Center Kovrov, Russia.
FAU - Rokkas, Theodore
AU  - Rokkas T
AD  - Gastroenterology Unit, Henry Dunant Hospital, Athens, Greece.
FAU - Georgopoulos, Sotirios
AU  - Georgopoulos S
AD  - Gastroenterology Unit, Athens Medical Center, Paleo Faliron General Hospital 
      Athens, Greece.
FAU - Pellicano, Rinaldo
AU  - Pellicano R
AD  - Gastroenterology Unit, Molinette Hospital Turin, Italy.
FAU - Buzas, Gyorgy M
AU  - Buzas GM
AD  - Gastroenterology Unit, Ferencvaros Policlinic, Budapest, Hungary.
FAU - Modolell, Ines
AU  - Modolell I
AD  - Gastroenterology Unit, Consorci Sanitari Terrassa, Spain.
FAU - Gomez Rodriguez, Blas Jose
AU  - Gomez Rodriguez BJ
AD  - Gastroenterology Unit, Hospital Universitario Virgen Macarena, Sevilla, Spain.
FAU - Simsek, Ilkay
AU  - Simsek I
AD  - Gastroenterology Unit, Dokuz Eylul University School of Medicine, Izmir, Turkey.
FAU - Simsek, Cem
AU  - Simsek C
AD  - Gastroenterology Unit, Hacettepe University Ankara, Turkey.
FAU - Lafuente, Marina Roldan
AU  - Lafuente MR
AD  - Gastroenterology Unit, Hospital General Universitario de Castellon, Spain.
FAU - Ilchishina, Tatiana
AU  - Ilchishina T
AD  - Gastroenterology Unit, SM-clinic, Saint-Petersburg, Russia.
FAU - Camarero, Judith Gomez
AU  - Camarero JG
AD  - Gastroenterology Unit, Hospital Universitario de Burgos, Spain.
FAU - Dominguez-Cajal, Manuel
AU  - Dominguez-Cajal M
AD  - Gastroenterology Unit, Hospital San Jorge Huesca, Spain.
FAU - Ntouli, Vassiliki
AU  - Ntouli V
AD  - Gastroenterology Unit, General Hospital Pireaus, Greece.
FAU - Dekhnich, Natalia Nikolaevna
AU  - Dekhnich NN
AD  - Gastroenterology Unit, Institute of Antimicrobial Chemotherapy, Smolensk, Russia.
FAU - Phull, Perminder
AU  - Phull P
AD  - Gastroenterology Unit, Aberdeen Royal Infirmary Aberdeen, United Kingdom.
FAU - Nunez, Oscar
AU  - Nunez O
AD  - Gastroenterology Unit, Hospital Universitario Sanitas La Moraleja, Madrid, Spain.
FAU - Lerang, Frode
AU  - Lerang F
AD  - Gastroenterology Unit, Medical Department, Central Hospital Ostfold, Fredrikstad, 
      Norway.
FAU - Venerito, Marino
AU  - Venerito M
AD  - Gastroenterology Unit, Department of Gastroenterology, Hepatology and Infectious 
      Diseases, Otto-von-Guericke University Hospital, Magdeburg, Germany.
FAU - Heluwaert, Frederic
AU  - Heluwaert F
AD  - Gastroenterology Unit, Center Hospitalier Annecy Genvois, Pringy, France.
FAU - Tonkic, Ante
AU  - Tonkic A
AD  - Gastroenterology Unit, University Hospital of Split, School of Medicine, 
      University of Split, Croatia.
FAU - Caldas, Maria
AU  - Caldas M
AD  - Gastroenterology Unit, Hospital Universitario de La Princesa, Instituto de 
      Investigacion Sanitaria Princesa (IIS-IP), Universidad Autonoma de Madrid, Centro 
      de Investigacion Biomedica en Red de Enfermedades Hepaticas y Digestivas 
      (CIBEREHD), Madrid, Spain.
FAU - Puig, Ignasi
AU  - Puig I
AD  - Gastroenterology Unit, Althaia Xarxa Assistencial Universitaria de Manresa and 
      Universitat de Vic-Universitat Central de Catalunya (UVicUCC), Manresa, Spain.
FAU - Megraud, Francis
AU  - Megraud F
AD  - Gastroenterology Unit, Laboratoire de Bacteriologie, Hopital Pellegrin, Bordeaux, 
      France.
FAU - O'Morain, Colm
AU  - O'Morain C
AD  - Gastroenterology Unit, Department of Clinical Medicine, Trinity College Dublin, 
      Ireland.
FAU - Gisbert, Javier P
AU  - Gisbert JP
AD  - Gastroenterology Unit, Hospital Universitario de La Princesa, Instituto de 
      Investigacion Sanitaria Princesa (IIS-IP), Universidad Autonoma de Madrid, Centro 
      de Investigacion Biomedica en Red de Enfermedades Hepaticas y Digestivas 
      (CIBEREHD), Madrid, Spain.
CN  - Hp-EuReg Investigators
LA  - eng
SI  - ClinicalTrials.gov/NCT02328131
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Am J Gastroenterol
JT  - The American journal of gastroenterology
JID - 0421030
RN  - 0 (Anti-Bacterial Agents)
RN  - 0 (Proton Pump Inhibitors)
RN  - U015TT5I8H (Bismuth)
SB  - IM
MH  - Anti-Bacterial Agents/*adverse effects/therapeutic use
MH  - Bismuth/*adverse effects/therapeutic use
MH  - Drug Therapy, Combination
MH  - Drug-Related Side Effects and Adverse Reactions/*epidemiology
MH  - Europe/epidemiology
MH  - Female
MH  - Helicobacter Infections/*drug therapy/epidemiology
MH  - Helicobacter pylori
MH  - Humans
MH  - Incidence
MH  - Male
MH  - Middle Aged
MH  - Proton Pump Inhibitors/*adverse effects/therapeutic use
MH  - Registries
COIS- The remaining list of authors, their affiliations, contributions and conflicts of 
      interests are listed in Supplementary file 1. Contribution Log, available online 
      at http://links.lww.com/AJG/B961.
EDAT- 2021/04/13 06:00
MHDA- 2021/07/01 06:00
CRDT- 2021/04/12 06:09
PHST- 2020/07/07 00:00 [received]
PHST- 2021/02/23 00:00 [accepted]
PHST- 2021/04/13 06:00 [pubmed]
PHST- 2021/07/01 06:00 [medline]
PHST- 2021/04/12 06:09 [entrez]
AID - 00000434-202106000-00021 [pii]
AID - 10.14309/ajg.0000000000001246 [doi]
PST - ppublish
SO  - Am J Gastroenterol. 2021 Jun 1;116(6):1220-1229. doi: 
      10.14309/ajg.0000000000001246.