| Author |
Lee, Hee Yeon Kim, Hoon-Kyo Lee, Kyung Hee Kim, Bong-Seog Song, Hong Suk Yang, Sung Hyun Kim, Joon Hee Kim, Yeul Hong Kim, Jong Gwang Kim, Sang-We Kim, Dong-Wan Kim, Si-Young Park, Hee Sook |
| Description |
Author Affiliation: Lee HY ( Department of Internal Medicine, St. Vincent's Hospital, The Catholic University of Korea College of Medicine, Suwon, Korea.); Kim HK ( Department of Internal Medicine, St. Vincent's Hospital, The Catholic University of Korea College of Medicine, Suwon, Korea.); Lee KH ( Department of Internal Medicine, Yeungnam University Medical Center, Yeungnam University College of Medicine, Daegu, Korea.); Kim BS ( Department of Internal Medicine, Seoul Veterans Hospital, Seoul, Korea.); Song HS ( Department of Internal Medicine, Keimyung University Dongsan Medical Center, Keimyung University School of Medicine, Daegu, Korea.); Yang SH ( Department of Internal Medicine, Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences, Seoul, Korea.); Kim JH ( Department of Internal Medicine, Inje University Seoul Paik Hospital, Inje University College of Medicine, Seoul, Korea.); Kim YH ( Department of Internal Medicine, Korea University Anam Hospital, Korea University School of Medicine, Seoul, Korea.); Kim JG ( Department of Internal Medicine, Kyungpook National University Hospital, Kyungpook National University School of Medicine, Daegu, Korea.); Kim SW ( Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.); Kim DW ( Department of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.); Kim SY ( Department of Internal Medicine, Kyung Hee University Medical Center, Kyung Hee University School of Medicine, Seoul, Korea.); Park HS ( Department of Internal Medicine, Soonchunhyang University Hospital, Soonchunhyang University College of Medicine, Seoul, Korea.) |
| Abstract |
PURPOSE: This study was conducted to evaluate the efficacy and safety of azasetron compared to ondansetron in the prevention of delayed chemotherapy-induced nausea and vomiting. MATERIALS AND METHODS: This study was a multi-center, prospective, randomized, double-dummy, double-blind and parallel-group trial involving 12 institutions in Korea between May 2005 and December 2005. A total of 265 patients with moderately and highly emetogenic chemotherapy were included and randomly assigned to either the azasetron or ondansetron group. All patients received azasetron (10 mg intravenously) and dexamethasone (20 mg intravenously) on day 1 and dexamethasone (4 mg orally every 12 hours) on days 2-4. The azasetron group received azasetron (10 mg orally) with placebo of ondansetron (orally every 12 hours), and the ondansetron group received ondansetron (8 mg orally every 12 hours) with placebo of azasetron (orally) on days 2-6. RESULTS: Over days 2-6, the effective ratio of complete response in the azasetron and ondansetron groups was 45% and 54.5%, respectively (95% confidence interval, -21.4 to 2.5%). Thus, the non-inferiority of azasetron compared with ondansetron in delayed chemotherapy-induced nausea and vomiting was not proven in the present study. All treatments were well tolerated and no unexpected drug-related adverse events were reported. The most common adverse events related to the treatment were constipation and hiccups, and there were no differences in the overall incidence of adverse events. CONCLUSION: In the present study, azasetron showed inferiority in the control of delayed chemotherapy-induced nausea and vomiting compared with ondansetron whereas safety profiles were similar between the two groups. |
