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Sequential Therapy for First-Line Helicobacter pylori Eradication: 10- or 14-Day Regimen?

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Angelo Zullo1, Giulia Fiorini2, Giuseppe Scaccianoce3, Piero Portincasa3, Vincenzo De Francesco4, Roberto Vassallo5, Flavia Urban6, Fabio Monica6, Giuseppe Mogavero7, Arnaldo Amato7, Dino Vaira2

1) Gastroenterology and Digestive Endoscopy, ‘Nuovo Regina Margherita’ Hospital, Rome
2) Department of Medical and Surgical Sciences, ‘S. Orsola’ Hospital, University of Bologna, Bologna
3) Internal Medicine A. Murri, Department of Biomedical Sciences & Human Oncology, University of Bari, Bari
4) Section of Gastroenterology, Department of Medical Sciences, University of Foggia, Foggia
5) Gastroenterology and Digestive Endoscopy; “Buccheri la Ferla, Fatebenefratelli” Hospital, Palermo
6) Gastroenterology and Digestive Endoscopy, Academic Hospital Cattinara, Trieste
7) Gastroenterology Unit, ‘Valduce’ Hospital, Como, Italy

DOI: http://dx.doi.org/10.15403/jgld.2014.1121.281.hpy

Background & Aim: Standard 10-day sequential therapy is advised as first-line therapy for Helicobacter pylori (H. pylori) eradication by current Italian guidelines. Some data suggested that a 14-day regimen may achieve higher eradication rates. This study compared the efficacy of sequential therapy administered for either 10- or 14-days.
Methods: This prospective, multicenter, open-label study enrolled patients with H. pylori infection without previous treatment. Patients were receiving a sequential therapy for either 10 or 14 days with esomeprazole 40 mg and amoxicillin 1 g (5 or 7 days) followed by esomeprazole 40 mg, clarithromycin 500 mg and tinidazole 500 mg (5 or 7 days), all given twice daily. Bacterial eradication was checked using 13C-urea breath test. Eradication cure rates were calculated at both Intention-to-treat (ITT) and per-protocol (PP) analyses.
Results: A total of 291 patients were enrolled, including 146 patients in 10-day and 145 in the 14-day regimen. The eradication rates were 87% (95% CI = 81.5-92.4) and 90.3% (95% CI = 85.5-95.1) at ITT analysis with the 10- and 14-day regimen, respectively, and 92.7% (95% CI = 88.3-97) and 97% (95% CI = 94.2-99.9) at PP analysis (p =0.37). Among patients, who earlier had interrupted therapy, bacterial eradication was achieved in 8 out of 9 who completed the first therapy phase and performed at least ≥3 days of triple therapy in the second phase.
Conclusion: This study found that both 10- and 14-day sequential therapies achieved a high eradication rate for first-line H. pylori therapy in clinical practice.
Key words: Helicobacter pylori – sequential therapy – eradication.
Abbrevations: CI: confidence intervals; ITT: intention to treat; PP: per protocol; SD: standard deviation; UBT: urea breath test.