We appreciate the comments of Dr. Calvet and colleagues, who disagree with our conclusion that prolonging triple therapy is unlikely to be a clinically useful strategy. One of the aims of our meta-analysis was to verify whether current European and U.S. recommendations (1, 2) that support 14 days as the duration of choice reflect the available data. Undoubtedly, increasing the duration of treatment from 7 to 14 days will statistically significantly increase the eradication rate by 5% (95% CI, 2% to 8%); however, this improvement is substantially lower than what was previously accepted (12%) (3). A statistically significant finding is not necessarily clinically significant in daily clinical practice. In the U.S. trial comparing different durations of triple therapy (4), 2 regimens were considered therapeutically equivalent if the CI was within the equivalence range of –15% to 15%. Of note, this cut-off was decided in consultation with the U.S. Food and Drug Administration (4). The result of our meta-analysis was largely within this range (CI, 2% to 8%). Dr. Calvet and colleagues suggested that the inclusion of the 2 large studies of patients with peptic ulcer could have provided an underestimation of the benefit of prolonging treatment. We performed a sensitivity analysis excluding these 2 large studies, and the result did not substantially change (7% [CI, 3% to 11%]). As expected, the difference slightly increases, but the range was, again, largely within the equivalence range. Finally, a cost-effectiveness analysis performed by Dr. Calvet and associates (5), and on the basis of a 9% increase in eradication with the longer therapy duration, concluded that "7-day therapy seems the most cost-effective strategy."

Could Increasing the Duration of Triple Therapy Be a Clinically Useful Strategy?

FUCCIO, LORENZO;ZAGARI, ROCCO MAURIZIO;BAZZOLI, FRANCO
2008

Abstract

We appreciate the comments of Dr. Calvet and colleagues, who disagree with our conclusion that prolonging triple therapy is unlikely to be a clinically useful strategy. One of the aims of our meta-analysis was to verify whether current European and U.S. recommendations (1, 2) that support 14 days as the duration of choice reflect the available data. Undoubtedly, increasing the duration of treatment from 7 to 14 days will statistically significantly increase the eradication rate by 5% (95% CI, 2% to 8%); however, this improvement is substantially lower than what was previously accepted (12%) (3). A statistically significant finding is not necessarily clinically significant in daily clinical practice. In the U.S. trial comparing different durations of triple therapy (4), 2 regimens were considered therapeutically equivalent if the CI was within the equivalence range of –15% to 15%. Of note, this cut-off was decided in consultation with the U.S. Food and Drug Administration (4). The result of our meta-analysis was largely within this range (CI, 2% to 8%). Dr. Calvet and colleagues suggested that the inclusion of the 2 large studies of patients with peptic ulcer could have provided an underestimation of the benefit of prolonging treatment. We performed a sensitivity analysis excluding these 2 large studies, and the result did not substantially change (7% [CI, 3% to 11%]). As expected, the difference slightly increases, but the range was, again, largely within the equivalence range. Finally, a cost-effectiveness analysis performed by Dr. Calvet and associates (5), and on the basis of a 9% increase in eradication with the longer therapy duration, concluded that "7-day therapy seems the most cost-effective strategy."
Lorenzo Fuccio; Rocco Maurizio Zagari; and Franco Bazzoli
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/11585/64053
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