Though treatments aimed at the eradication of Helicobacter pylori (H pylori) have demonstrated robust efficacy in research and real-world clinical practice, there remains a gap in knowledge regarding the frequency and severity of adverse events (AEs) related to these eradication therapies. An analysis of real-world data demonstrates that while these agents frequently cause side effects, these AEs are generally mild, transient, and do not significantly affect compliance with therapy. Findings from the analysis were published in the American Journal of Gastroenterology.
To investigate the frequency and severity of AEs associated with H pylori treatments in clinical practice, a large research team conducted an analysis of the European Registry on H pylori Management (Hp-EuReg). The registry was launched in 2013. Researchers focused their analysis on clinical practice data for European gastroenterologists spanning 27 countries and 22,492 patients (mean age, 51±17.4 years) who were treated with H pylori therapies.
Indications for eradication included functional dyspepsia (35%), noninvestigated dyspepsia (20%), and peptic ulcers (17%). Approximately 23% of overall cases had ≥1 AE with treatment, with the most frequent being taste disturbance (7%), diarrhea (7%), nausea (6%), and abdominal pain (3%). The majority of AEs were mild (57%) in severity. Overall, the mean duration of AEs was 7.3±4.2 days and ranged between 1 and 45 days.
Among the 14 most frequently prescribed treatments, the incidence of AEs was 22% (n=4298). The highest incidences of AEs were reported with classical bismuth quadruple therapy containing a proton pump inhibitor, bismuth salts, metronidazole, and either tetracycline or doxycycline (37% and 33%, respectively), in addition to bismuth quadruple therapy with amoxicillin and clarithromycin, levofloxacin, or josamycin (34%, 32%, and 32%, respectively).
Only 1.3% of patients discontinued therapy due to AEs. While 0.08% (n=20) of patients experienced serious AEs that required hospitalization, these events resolved without sequelae.
Due to the large cohort size, investigators note it was difficult to compare AE profiles across a registry with so many different investigators and treatment therapies.
Despite the overall incidence of AEs, compliance to therapy was 97%. “Together with anti- biotic resistance, compliance with therapy is the most important factor predicting H. pylori eradication,” wrote the researchers, “[and] therefore, this represents a clinically relevant aspect of all regimens.”
Disclosure: Multiple authors declared affiliations with the pharmaceutical industry. Please refer to the original article for a full list of disclosures.
Nyssen OP, Perez-Aisa A, Tepes B, et al. 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). Am J Gastroenterol. 2021;116(6):1220-1229.