Efficacy and safety of single-triple capsules of bismuth biskalcitrate, metronidazole and tetracycline, given with omeprazole, for the eradication of Helicobacter pylori: an international multicentre study.

C. O'Morain, T. Borody, A. Farley, W. A. De Boer, C. Dallaire, R. Schuman, J. Piotrowski, C. A. Fallone, G. Tytgat, F. Mégraud & J. Spérnard

Aliment Pharmacal Ther 2003; 17: 415-420.

Data based on an international, multicenter study that assessed the efficacy of quadruple therapy using single-triple capsules of bismuth biskalcitrate (140 mg), metronidazole (125 mg) and tetracycline (125 mg) given with omeprazole (20 mg). 170 patients were treated in 8 centers located in 5 countries including the US. Patients received 3 single-triple capsules q.i.d. and omeprazole b.d. Overall eradication rates were 93% (158/170) by modified intent-to-treat analysis and 97% (142/146) by per protocol analysis.

Efficacy & Overcoming Resistance

"Eradication rates by both modified intention-to-treat and per protocol analyses were above 90%, showing the effectiveness of quadruple therapy against H. pylori as measured by existing standards."

"This treatment, when given for 10 days, appears to contain the appropriate combination of ingredients to overcome metronidazole resistance, a shortcoming of other bismuth-based combinations used previously."

Case Study Chart
*Modified intention-to-treat

Safety & Compliance

"Safety data showed that the treatment was well tolerated, as the usual profile of adverse events for this patient population was exhibited. The few patients with severe non-serious adverse events had their situations resolved, and the only patient with serious adverse events was able to complete the study."

Compliance was defined as taking at least 75% of the study drug and was evaluated by capsule count. The compliance level was 95% in the modified intention-to-treat group and 97% in the per protocol group.

Conclusion

"This omeprazole-bismuth biskalcitrate-metronidazole-tetracycline 10-day regimen is a very effective and well-tolerated treatment, which overcomes metronidazole resistance."

As with other antibiotics, use of tetracycline hydrochloride may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, tetracycline should be discontinued and appropriate therapy should be instituted.