ObjectiveThe best approach for Helicobacter pylori management remains unclear. An audit process is essential to ensure clinical practice is aligned with best standards of care.DesignInternational multicentre prospective non-interventional registry starting in 2013 aimed to evaluate the decisions and outcomes in H. pylori 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.Results30 394 patients from 27 European countries were evaluated and 21 533 (78%) first-line empirical H. pylori 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%).ConclusionManagement of H. pylori 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.
Concomitant therapy led to a non-statistically significant advantage (5%) over sequential therapy, coming closer to 90% cure rates. Both therapies showed an acceptable safety profile. ClincialTrials.gov: NCT01273441.
EPI is a frequent but under-recognized complication of pancreatic surgery. These guidelines provide evidence-based recommendations for the definition, diagnosis, and management of EPI after pancreatic surgery.
Summary
Background
Empiric triple therapy for Helicobacter pylori should be abandoned when clarithromycin resistance rate is >15–20%. Optimisation of triple therapy (high‐dose acid suppression and 14‐day duration) can increase eradication rates by 10%.
Aim
To compare the efficacy and safety of optimised triple (OPT‐TRI) and nonbismuth quadruple concomitant (OPT‐CON) therapies.
Methods
Prospective multicentre study in 16 Spanish centres using triple therapy in clinical practice. In a 3‐month two‐phase fashion, the first 402 patients received an OPT‐TRI therapy [esomeprazole (40 mg b.d.), amoxicillin (1 g b.d) and clarithromycin (500 mg b.d) for 14 days] and the last 375 patients an OPT‐CON treatment [OPT‐TRI therapy plus metronidazole (500 mg b.d)].
Results
Seven‐hundred seventy‐seven consecutive patients were included (402 OPT‐TRI, 375 OPT‐CON). The OPT‐CON therapy achieved significantly higher eradication rates in the per‐protocol [82.3% (95% CI = 78–86%) vs. 93.8% (91–96%), P < 0.001] and intention‐to‐treat analysis [81.3% (78–86%) vs. 90.4% (87–93%), P < 0.001]. Adverse events (97% mild/moderate) were significantly more common with OPT‐CON therapy (39% vs. 47%, P = 0.016), but full compliance with therapy was similar between groups (94% vs. 92%, P = 0.4). OPT‐CON therapy was the only significant predictor of successful eradication (odds ratio, 2.24; 95% CI: 1.48–3.51, P < 0.001). The rate of participating centres achieving cure rates ≥90% favoured OPT‐CON therapy (OPT‐TRI 25% vs. OPT‐CON 62%).
Conclusions
Empiric OPT‐CON therapy achieved significantly higher cure rates (>90%) compared to OPT‐TRI therapy. Addition of metronidazole to OPT‐TRI therapy increased eradication rates by 10%, resulting in more mild adverse effects, but without impairing compliance with therapy.
Levofloxacin-based rescue therapy constitutes an encouraging empirical third-line strategy after multiple previous H. pylori eradication failures with key antibiotics such as amoxicillin, clarithromycin, metronidazole, and tetracycline.
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