To assess the frequency, type, intensity and duration of adverse events (AEs) and their impact on compliance for the most frequently used treatments in the “European Registry on
Helicobacter Pylori Management,” a 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 was evaluated.
All prescribed eradication treatments and their corresponding safety profiles were reported. AEs were classified, depending on the intensity of symptoms as mild/moderate/ severe and as serious AEs. All data was subject to quality control.
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 0.8% 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.
It was concluded that HP eradication treatment frequently induces AEs, although they are usually mild and of limited duration. Their appearance does not interfere significantly with treatment compliance.
Nyssen, O., Perez-Aisa, A., Tepes, B., et al on behalf of the Hp-EuReg Investigators. “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).” American Journal of Gastroenterology, 2021; Vol. 116, pp. 1220-1229.