A Randomized Double-Blind, Double-Dummy, Multicenter Trial of Azasetron versus Ondansetron to Evaluate Efficacy and Safety in the Prevention of Delayed Nausea and Vomiting Induced by Chemotherapy
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PurposeThis study was conducted to evaluate the efficacy and safety of azasetron comparedto ondansetron in the prevention of delayed chemotherapy-induced nausea andvomiting. Materials and MethodsThis study was a multi-center, prospective, randomized, double-dummy, double-blindand parallel-group trial involving 12 institutions in Korea between May 2005 andDecember 2005. A total of 265 patients with moderately and highly emetogenicchemotherapy were included and randomly assigned to either the azasetron orondansetron group. All patients received azasetron (10 mg intravenously) anddexamethasone (20 mg intravenously) on day 1 and dexamethasone (4 mg orally every12 hours) on days 2-4. The azasetron group received azasetron (10 mg orally) withplacebo of ondansetron (orally every 12 hours), and the ondansetron group receivedondansetron (8 mg orally every 12 hours) with placebo of azasetron (orally) on days2-6. ResultsOver days 2-6, the effective ratio of complete response in the azasetron andondansetron groups was 45% and 54.5%, respectively (95% confidence interval,‒21.4 to 2.5%). Thus, the non-inferiority of azasetron compared with ondansetron indelayed chemotherapy-induced nausea and vomiting was not proven in the presentstudy. All treatments were well tolerated and no unexpected drug-related adverseevents were reported. The most common adverse events related to the treatmentwere constipation and hiccups, and there were no differences in the overall incidenceof adverse events. ConclusionIn the present study, azasetron showed inferiority in the control of delayed chemotherapy-induced nausea and vomiting compared with ondansetron whereas safety profileswere similar between the two groups.
Abstract
PurposeThis study was conducted to evaluate the efficacy and safety of azasetron comparedto ondansetron in the prevention of delayed chemotherapy-induced nausea andvomiting. Materials and MethodsThis study was a multi-center, prospective, randomized, double-dummy, double-blindand parallel-group trial involving 12 institutions in Korea between May 2005 andDecember 2005. A total of 265 patients with moderately and highly emetogenicchemotherapy were included and randomly assigned to either the azasetron orondansetron group. All patients received azasetron (10 mg intravenously) anddexamethasone (20 mg intravenously) on day 1 and dexamethasone (4 mg orally every12 hours) on days 2-4. The azasetron group received azasetron (10 mg orally) withplacebo of ondansetron (orally every 12 hours), and the ondansetron group receivedondansetron (8 mg orally every 12 hours) with placebo of azasetron (orally) on days2-6. ResultsOver days 2-6, the effective ratio of complete response in the azasetron andondansetron groups was 45% and 54.5%, respectively (95% confidence interval,‒21.4 to 2.5%). Thus, the non-inferiority of azasetron compared with ondansetron indelayed chemotherapy-induced nausea and vomiting was not proven in the presentstudy. All treatments were well tolerated and no unexpected drug-related adverseevents were reported. The most common adverse events related to the treatmentwere constipation and hiccups, and there were no differences in the overall incidenceof adverse events. ConclusionIn the present study, azasetron showed inferiority in the control of delayed chemotherapy-induced nausea and vomiting compared with ondansetron whereas safety profileswere similar between the two groups.
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