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)

Olga P Nyssen  1 , Angeles Perez-Aisa  2 , Bojan Tepes  3 , Manuel Castro-Fernandez  4 , Juozas Kupcinskas  5 , Laimas Jonaitis  5 , Luis Bujanda  6 , Alfredo Lucendo  7 , Natasa Brglez Jurecic  8 , Jorge Perez-Lasala  9 , Oleg Shvets  10 , Galina Fadeenko  11 , Jose M Huguet  12 , Zdenki Kikec  13 , Dmitry Bordin  14   15   16 , Irina Voynovan  14 , Marcis Leja  17 , Jose Carlos Machado  18 , Miguel Areia  19 , Luis Fernandez-Salazar  20 , Luis Rodrigo  21 , Sergey Alekseenko  22 , Jesus Barrio  23 , Juan Ortuño  24 , Monica Perona  25 , Liudmila Vologzhanina  26 , Pilar Mata Romero  27 , Oleg Zaytsev  28 , Theodore Rokkas  29 , Sotirios Georgopoulos  30 , Rinaldo Pellicano  31 , Gyorgy M Buzas  32 , Ines Modolell  33 , Blas Jose Gomez Rodriguez  34 , Ilkay Simsek  35 , Cem Simsek  36 , Marina Roldan Lafuente  37 , Tatiana Ilchishina  38 , Judith Gomez Camarero  39 , Manuel Dominguez-Cajal  40 , Vassiliki Ntouli  41 , Natalia Nikolaevna Dekhnich  42 , Perminder Phull  43 , Oscar Nuñez  44 , Frode Lerang  45 , Marino Venerito  46 , Frederic Heluwaert  47 , Ante Tonkic  48 , Maria Caldas  1 , Ignasi Puig  49 , Francis Megraud  50 , Colm O'Morain  51 , Javier P Gisbert  1 , Hp-EuReg Investigators

Am J Gastroenterol . 2021 Jun 1;116(6):1220-1229.

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.

Trial registration: ClinicalTrials.gov NCT02328131.