HELICOBACTER PYLORI

Comparison of 1 and 2 weeks of omeprazole, amoxicillin and clarithromycin treatment for Helicobacter pylori eradication: the HYPER Study

Rocco Maurizio Zagari¹, Gabriele Bianchi-Porro², Roberto Fiocca³, Giovanni Gasbarrini⁴, Enrico Roda¹, Franco Bazzoli¹

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

Correspondence to:
Professor Franco Bazzoli
Dipartimento di Medicina Interna e Gastroenterologia, Università di Bologna, Policlinico S Orsola, Via Massarenti 9, 40138 Bologna, Italy;franco.bazzoli{at}Unibo.it

Background: Triple therapy is recommended for Helicobacter pylori eradication, yet consensus on the duration of treatment is lacking.

Aim: To compare the efficacy and safety of 1- and 2-week regimens of omeprazole, amoxicillin and clarithromycin in a large, multicentre, double-blind and randomised study.

Methods: A total of 909 H pylori-positive patients with duodenal ulcer, enrolled in 81 endoscopy units in Italy, were randomised to receive omeprazole, amoxicillin and clarithromycin for either 1 week (OAC1W) or 2 weeks (OAC2W) or omeprazole and amoxicillin for 2 weeks. H pylori eradication was assessed by histological examination and carbon-13 urea breath test 4 weeks after treatment.

Results: Both the intention-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 omeprazole, amoxicillin and clarithromycin regimens gave significantly higher eradication rates compared with omeprazole and amoxicillin 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 omeprazole and amoxicillin, 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 omeprazole and amoxicillin (p = 0.11).

Conclusions: 1-week and 2-week triple treatments for H pylori eradication are similar in terms of efficacy, safety and patient compliance.

Abbreviations: ¹³C-UBT, carbon-13 urea breath test; ITT, intention-to-treat; OAC1W, omeprazole 20 mg twice daily and amoxicillin 1 g twice daily and clarithromycin 500 mg twice daily for 1 week, followed by omeprazole 20 mg twice daily and placebo for 1 week; OAC2W, omeprazole 20 mg twice daily and amoxicillin 1 g twice daily and clarithromycin 500 g twice daily for 2 weeks; PPI, proton pump inhibitor

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One- or two-week triple therapy for Helicobacter pylori: questions of efficacy and inclusion of a dual therapy treatment arm • Authors’ response

David Y Graham, Yoshio Yamaoka, Rocco Maurizio Zagari, and Franco Bazzoli
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