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European Registry on Management (Hp-EuReg): Patterns and Trends in First-line Empirical Eradication Prescription and Outcomes of 5 Years and 21 533 Patients

Abstract

Objective: The best approach for management remains unclear. An audit process is essential to ensure clinical practice is aligned with best standards of care.

Design: International multicentre prospective non-interventional registry starting in 2013 aimed to evaluate the decisions and outcomes in management by European gastroenterologists. Patients were registered in an e-CRF by AEG-REDCap. Variables included demographics, previous eradication attempts, prescribed treatment, adverse events and outcomes. Data monitoring was performed to ensure data quality. Time-trend and geographical analyses were performed.

Results: 30 394 patients from 27 European countries were evaluated and 21 533 (78%) first-line empirical treatments were included for analysis. Pretreatment resistance rates were 23% to clarithromycin, 32% to metronidazole and 13% to both. Triple therapy with amoxicillin and clarithromycin was most commonly prescribed (39%), achieving 81.5% modified intention-to-treat eradication rate. Over 90% eradication was obtained only with 10-day bismuth quadruple or 14-day concomitant treatments. Longer treatment duration, higher acid inhibition and compliance were associated with higher eradication rates. Time-trend analysis showed a region-dependent shift in prescriptions including abandoning triple therapies, using higher acid-inhibition and longer treatments, which was associated with an overall effectiveness increase (84%-90%).

Conclusion: Management of infection by European gastroenterologists is heterogeneous, suboptimal and discrepant with current recommendations. Only quadruple therapies lasting at least 10 days are able to achieve over 90% eradication rates. European recommendations are being slowly and heterogeneously incorporated into routine clinical practice, which was associated with a corresponding increase in effectiveness.

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