Treatment options for Helicobacter pylori infection when proton pump inhibitor-based triple therapy fails in clinical practice

Background: The effectiveness of Helicobacter pylori eradication regimens h as not been extensively investigated in the clinical practice setting. The optimal treatment choice after an initial failed eradication attempt has no t been determined. Aims: To evaluate proton pump inhibitor-based triple therapies as first-lin e eradication regimens in clinical practice, and to establish the efficacy of second-line regimens in the context of an initial failed eradication att empt. Methods: Three hundred and eight patients with dyspepsia and evidence of H. pylori at endoscopy were recruited. As first-line therapy, 116 patients re ceived omeprazole 20 mg b.d. in combination with amoxycillin 1 g b.d. and c larithromycin 500 mg b.d. (OAC) while 192 patients received omeprazole 20 m g b.d. in combination with metronidazole 400 mg b.d. and clarithromycin 250 mg b.d. (OMC). H, pylori status was reassessed at least 4 weeks after ther apy (25 patients failed to attend for further testing). Of 52 patients with an initial failed eradication attempt, 20 patients received a 1 week quadr uple therapy regimen incorporating omeprazole 20 mg b.d., tripotassium dici trato bismuthate 120 mg q.d.s., tetracycline 500 mg q.d.s, and metronidazol e 400 mg t.d.s., 20 patients received a 2-week proton pump inhibitor-based triple therapy regimen as described, and 12 patients received a further 1-w eek proton pump inhibitor-based triple therapy regimen. Results: Including 308 patients, the intention-to-treat (ITT) eradication r ates for OAC and OMC as first-line regimens were 72% (95% CI: 63-80%) and 7 3% (95% CI: 67-79%) respectively. A per protocol (PP) analysis on the 283 p atients who completed follow-up gives an initial eradication rate of 78% (9 5% CI: 69-86%) for OAC and 79% (95% CI: 73-85%) for OMC. There were 60 pati ents (21%; 95% CI: 17-26%) in whom the initial eradication attempt was unsu ccessful. With second-line therapy, H. pylori was successfully eradicated i n a further 35/52 (67%; 95% CI: 58-73%) patients. The eradication rates wit h the quadruple regimen and 2-week triple therapy regimens were 75% (95% CI : 56-94%) and 80% (95% CI: 63-98%) respectively (P = 0.71). The eradication rate with a repeat 1-week regimen was 33% (95% CI: 7-60%). Conclusions: The eradication rates achieved in this 'in practice' study wit h recommended first-line 1-week proton pump inhibitor-based triple therapy regimens were lower than the rates achieved with similar regimens in the cl inical trial setting. A repeat 1-week proton pump inhibitor-based triple th erapy regimen was not successful as a salvage therapy. Both the 2-week prot on pump inhibitor-based triple therapy regimen and the 1-week quadruple the rapy regimen were successful second-line treatments in greater than or equa l to 75% of patients.