Eradication of Helicobacter pylori infection with a new bismuth-based quadruple therapy in clinical practice.

Introduction: The eradication of Helicobacter pylori infection represents a clinical challenge.

Objective: To evaluate the efficacy and safety of quadruple therapy with esomeprazole plus a 3-in-1 capsule containing bismuth subcitrate, metronidazole and tetracycline, plus probiotics in patients diagnosed with H. pylori infection in routine clinical practice.

Methods: A prospective, interventional, single-centre and open-label study in consecutive patients with a confirmed indication for eradication of H. pylori infection. Patients were treated with three capsules of Pylera four times a day (breakfast, lunch, afternoon snack and dinner), plus 40mg of esomeprazole twice daily for 10 days (30min before breakfast and dinner) and probiotics for 30 days. Eradication of H. pylori infection was confirmed by labelled urea breath test performed at least 28 days after the end of treatment.

Results: A total of 100 patients were consecutively enrolled. Twenty-five patients (25.0%) had a prior history of treatment for their H. pylori infection. In the intention-to-treat population, eradication rates were 90.7% (68/75) and 80.0% (20/25) in patients treated with Pylera as the first line or as rescue therapy, respectively. Eighteen patients (18%) had at least one adverse event, most of which (89%) were mild.

Conclusion: Ten days of treatment with a quadruple regimen of bismuth, metronidazole and tetracycline plus esomeprazole and probiotics is an effective and safe strategy in patients with H. pylori infection.