Quadruple therapy outperforms triple for H pylori eradication
Bismuth-containing quadruple therapy should be considered as first-line treatment for Helicobacter pylori eradication in regions with high levels of clarithromycin resistance, according to a study published online in The Lancet today (22 February 2011).
According to the researchers, the randomised, open-label trial, conducted across 39 sites in Europe, is the first large-scale study comparing standard and quadruple therapy in nearly a decade. Participants received 10 days of quadruple therapy (omeprazole, bismuth subcitrate potassium, metronidazole and tetracycline) or seven days of triple therapy (omeprazole, amoxicillin and clarithromycin; see Panel).
The researchers found that quadruple therapy was non-inferior to triple therapy in the per-protocol analysis. In the intention-to-treat analysis, eradication rates were 80 per cent in the quadruple therapy group compared with 55 per cent in the standard therapy group (P<0.0001).
“Data from our study corroborate the safety and tolerability of bismuth in Europe and highlight the effect of antibiotic resistance on eradication efficacy between combination treatments. Clarithromycin-resistant H pylori continues to increase in prevalence, and although rates of metronidazole resistance are also high, the results from our study showed that clarithromycin resistance reduces the efficacy of standard therapy, whereas resistance to metronidazole has a slight effect on the efficacy of quadruple therapy,” the researchers say.
The safety profile for each regimen was similar, with gastrointestinal symptoms the most commonly reported.
Study method and results
The quadruple therapy group took proprietary three-in-one capsules containing bismuth subcitrate potassium 140mg, metronidazole 125mg and tetracycline 125mg, taken four times daily plus omeprazole 20mg twice daily. The triple therapy group took clarithromycin 500mg, amoxicillin 500mg and omeprazole 20mg, twice daily.Eradication rates were 80 per cent in the quadruple therapy group (95 per cent confidence interval 73.9-84.9) and 55 per cent in the triple therapy group (CI 48.6-62.1; P<0.0001).
Citation: The Pharmaceutical Journal URI: 11069221
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