High Helicobacter pylori eradication rate with a 1-week regimen containing ranitidine bismuth citrate

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Abstract

Background:

High Helicobacter pylori eradication rates have consistently been reported with 2-week dual therapy regimens of ranitidine bismuth citrate plus clarithromycin. Ranitidine bismuth citrate with two antibiotics may provide an alternative 1-week eradication regimen.

Methods:

This double-blind, randomized, parallel group, international, multicentre study compared ranitidine bismuth citrate 400 mg b.d. and clarithromycin 500 mg b.d. for 2 weeks (RC) with ranitidine bismuth citrate 400 mg b.d., clarithromycin 500 mg b.d. and metronidazole 400 mg b.d. for 1 week (RCM) for eradication of H. pylori in 350 patients with dyspepsia.

Results:

Treatment with RC and RCM eradicated H. pylori (established by the combination of two negative results from two discrete 13C-UBTs at nominal weeks 4 and 12) from 89% (95% CI: 84-94) and 92% (95% CI: 88-97) of the observed population, and from 78% (95% CI: 72-84) and 80% (95% CI: 75-86) of the intention-to-treat population. When established only by one negative 13C-UBT result at least 28 days after the end of treatment, the respective intention-to-treat rates were 85% (95% CI; 79-90) and 88% (95% CI: 83-93). Both regimens were well-tolerated, only 6% of patients given RC and 4% given RCM discontinued treatment. Median plasma bismuth concentrations at the end of the second week of study were low, at 3.5 and 0.4 ng/mL, respectively.

Conclusions:

Ranitidine bismuth citrate triple therapy for 1 week (RCM) and dual therapy for 2 weeks (RC) were equally effective for the eradication of H. pylori infection.

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