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Novel bismuth–metronidazole–tetracycline triple‐layer tablet for treatment of Helicobacter pylori
Author(s) -
Graham D. Y.,
Opekun A. R.,
Belson G.,
ElZimaity H. M. T.,
Carlson M. R.
Publication year - 2005
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1111/j.1365-2036.2005.02322.x
Subject(s) - metronidazole , medicine , helicobacter pylori , clarithromycin , tetracycline , gastroenterology , antibiotics , confidence interval , microbiology and biotechnology , biology
Summary Background: Current anti‐ Helicobacter pylori treatment regimens are costly and because of the increasing antibiotic resistance, are becoming ineffective. Aim: To evaluate a triple‐layer tablet containing 100 mg bismuth subcitrate, 250 mg metronidazole, and 250 mg tetracycline in a single triple‐layer tablet. Methods: H. pylori ‐infected adult patients received bismuth–metronidazole–tetracycline (two tablets, t.d.s.) and ranitidine (300 mg) once daily for 14 days. Efficacy was determined using 13 C‐urea breath testing. Results: Thirty‐three of 35 enrolled patients were available for evaluation; using the protocol‐specified modified intention‐to‐treat analysis, five failed treatment, two were lost to follow‐up (cure rate per‐protocol = 85.7%, intention‐to‐treat = 78.7%). The cure rate among metronidazole‐susceptible strains was 100% (22 of 22) (95% confidence interval 84–100%) compared with 55% (five of nine intention‐to‐treat) (95% confidence interval 21–86%) among metronidazole‐resistant strains. In four cases, therapy was truncated at 4–7 days because of side‐effects; yet the treatment was effective in three. The three metronidazole‐susceptible but clarithromycin‐resistant infections were cured. Conclusion: This novel triple‐layer tablet combination therapy was effective in all patients with metronidazole‐susceptible H. pylori and many of those with resistant organisms. A greater degree of acid suppression may further improve effectiveness.