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.
AbstractIntroduction: 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.
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