Once-daily therapy for H. pylori infection: a randomized comparison of four regimens.
OBJECTIVE
We sought to determine the efficacy and tolerability of novel, once-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 13C-urea breath test were randomly assigned to omeprazole 80 mg q.d. and metronidazole extended-release formulation 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 clarithromycin 1 g q.d. for 10 days (OMCI). A repeat breath test was done 6 wk after the completion of therapy. Subjects were considered compliant if they took > or = 80% of each study medication as prescribed.


RESULTS
Intent-to-treat eradication rates were OM = 8% (95% confidence interval [CI], 2-20%), OMAm = 35% (95% CI, 21-52%), OMAz = 65% (95% CI, 48-79%), and OMCI = 78% (95% CI, 62-89%). Lack of compliance was seen in 5% of subjects given OM, 8% given OMAm, 3% given OMAz, and 15% given OMCI.


CONCLUSIONS
This pilot study demonstrated that once-daily triple therapy with high-dose omeprazole, metronidazole extended-release formulation, and clarithromycin achieved an eradication rate approaching 80%. Further study may permit development of optimal once-daily dosing and enhance eradication rates.
Laine
L
L
U.S.C. School of Medicine, Los Angeles, California 90033, USA.
Estrada
R
R
Trujillo
M
M
Cheybani
K
K
Yeramian
P
P
Smith
S
S
Neil
G
G
D000328:Adult; D000658:Amoxicillin / Q000627:therapeutic use; D017963:Azithromycin / Q000627:therapeutic use; D017291:Clarithromycin / Q000627:therapeutic use; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination / Q000627:therapeutic use; D004791:Enzyme Inhibitors / Q000627:therapeutic use; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori; D006801:Humans; D008297:Male; D008795:Metronidazole / Q000627:therapeutic use; D009853:Omeprazole / Q000627:therapeutic use; D010865:Pilot Projects
D004791:Enzyme Inhibitors; D008795:Metronidazole; D000658:Amoxicillin; D017963:Azithromycin; D017291:Clarithromycin; D009853:Omeprazole