Comparison of one and two weeks of omeprazole, amoxicillin and clarithromycin treatment for Helicobacter pylori eradication: the HYPER study

Rocco Maurizio Zagari ¹, Gabriele Bianchi-Porro ², Roberto Fiocca ³, Giovanni Gasbarrini ⁴, Enrico Roda ¹ and Franco Bazzoli ^1*

¹ Department of Internal Medicine and Gastroenterology, University of Bologna, Italy
² Gastroenterology Unit, L. Sacco Hospital, Milan, Italy
³ Division of Anatomic Pathology, University of Genoa, Italy
⁴ Department of Internal Medicine, Policlinico Gemelli, Rome, Italy

^* To whom correspondence should be addressed. E-mail: franco.bazzoli{at}unibo.it.

Accepted 22 September 2006

Abstract

Background and aim: Proton pump inhibitor (PPI)- based triple therapies are recommended for Helicobacter pylori eradication, yet consensus on the duration of treatment is lacking. We aimed to compare the efficacy and safety of one- and two-week regimens of omeprazole, amoxicillin and clarithromycin in a large, multi-centre, double-blind and randomized study.

Methods: A total of 909 H. pylori positive patients with duodenal ulcer, enrolled in 81 endoscopy units in Italy, were randomized to receive omeprazole (O), amoxicillin (A) and clarithromycin (C) for either one week (OAC1W) or two weeks (OAC2W), or OA for two weeks. H. pylori eradication was assessed by histology and 13C-urea breath test four weeks after therapy.

Results: Both the intent-to-treat (ITT) (n = 907) and per protocol (PP) (n = 661) analyses showed no significant differences between the eradication rates of OAC1W (ITT: 79.7%; PP: 83.6%) and OAC2W (ITT: 81.7%; PP: 84.9%) (ITT: p = 0.53; PP: p = 0.71). Both triple OAC regimens gave significantly higher eradication rates compared with OA treatment (ITT: 44.6%; PP: 42.8%; p < 0.001). Poor compliance was reported in 18.6%, 17.3% and 15.1% (p = 0.51) of patients for OAC2W, OAC1W and OA, respectively. Adverse events occurred in 9.9% and 9.6% (p = 0.88) of patients for OAC2W and OAC1W, respectively, and in 5.9% for OA (p = 0.11).

Conclusions: One-week and two-week PPI-based triple therapies for H. pylori eradication are similar in terms of efficacy, safety and patient compliance.

Keywords: Helicobacter pylori, duodenal ulcer, eradication, triple therapy

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