Once-daily therapy for H-pylori infection: A randomized comparison of fourregimens

OBJECTIVE: We sought to determine the efficacy and tolerability of novel, o nce-daily therapies in the treatment of Helicobacter pylori infection. METHODS: One hundred sixty subjects with H. pylori infection documented by endoscopic biopsy or serology plus C-13-urea breath test were randomly assi gned to omeprazole 80 mg q.d, and metronidazole extended-release formulatio n 750 mg q.d. for 10 days (OM); OM plus amoxicillin 1.5 g q.d, for 10 days (OMAm); OM plus azithromycin 500 mg q.d. for 7 days (OMAz); or OM plus clar ithromycin 1 g q.d. for 10 days (OMCl). A repeat breath test was done 6 wk after the completion of therapy. Subjects were considered compliant if they took greater than or equal to 80% of each study medication as prescribed. RESULTS: Intent-to-treat eradication rates were OM = 8% (95% confidence int erval [CI], 2-20%), OMAm = 35% (95% CT, 21-52%), OMAz = 65% (95% CI, 48-79% ), and OMCl = 78% (95% CI, 62-89%). Lack of compliance was seen in 5% of su bjects given OM, 8% given OMAm, 3% given OMAz, and 15% given OMCl. CONCLUSIONS: This pilot study demonstrated that once-daily triple therapy w ith high-dose omeprazole, metronidazole extended-release formulation, and c larithromycin achieved an eradication rate approaching 80%. Further study m ay permit development of optimal once-daily dosing and enhance eradication rates. (C) 1999 by Am. Cell. of Gastroenterology.