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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.| 번호 | 참고문헌 | 국회도서관 소장유무 |
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| 1 | Rankings and symptom assessments of side effects from chemotherapy: insights from experienced patients with ovarian cancer ![]() |
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| 2 | Comparison of Ramosetron and Granisetron for the Prevention of Acute and Delayed Emesis in Cisplatin-Based Chemotherapy: a Randomized Controlled Trial ![]() |
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| 3 | Comparison of Azasetron and Ondansetron for Preventing Postoperative Nausea and Vomiting in Patients Undergoing Gynecological Laparoscopic Surgery | 소장 |
| 4 | Navari RM. Pathogenesis-based treatment of chemotherapyinduced nausea and vomiting: two new agents. J Support Oncol. 2003;1:89-103. | 미소장 |
| 5 | [High affinity binding of Y-25130 for serotonin 3 receptor]. ![]() |
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| 6 | [Pharmacokinetics of azasetron (Serotone), a selective 5-HT3 receptor antagonist]. ![]() |
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| 7 | [Comparison of ramosetron and azasetron for prevention of acute and delayed cisplatin-induced emesis in lung cancer patients]. ![]() |
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| 8 | [Clinical effect of two azasetron treatment methods against nausea and vomiting induced by anticancer drugs including CDDP]. ![]() |
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| 9 | Proposal for classifying the acute emetogenicity of cancer chemotherapy. ![]() |
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| 10 | Synthesis of 5-HT3 receptor antagonists, [11C]Y-25130 and [11C]YM060. ![]() |
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| 11 | Dose‐independent pharmacokinetics of ondansetron in rats: contribution of hepatic and intestinal first‐pass effects to low bioavailability ![]() |
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| 12 | Concentration of ondansetron in cerebrospinal fluid following oral dosing in volunteers. ![]() |
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| 13 | Effects of 5-HT 3 receptor antagonists on models of acute and delayed emesis induced by cisplatin in the ferret ![]() |
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| 14 | Should 5-hydroxytryptamine-3 receptor antagonists be administered beyond 24 hours after chemotherapy to prevent delayed emesis? Systematic re-evaluation of clinical evidence and drug cost implications. ![]() |
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| 15 | The effects of orally administered Y-25130, a selective serotonin3-receptor antagonist, on chemotherapeutic agent-induced emesis. ![]() |
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| 16 | [Analysis of antiemetic effect of various dosage regimens of azasetron hydrochloride based on 5-HT3 receptor occupancy of serotonin]. ![]() |
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| 17 | Review of the preclinical pharmacology and comparative efficacy of 5-hydroxytryptamine-3 receptor antagonists for chemotherapy-induced emesis. ![]() |
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| 18 | [A randomized crossover comparison of azasetron and granisetron in the prophylaxis of emesis induced by chemotherapy including cisplatin]. ![]() |
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| 19 | [Study on clinical effect of a continuous intravenous infusion of azasetron against nausea and vomiting induced by anticancer drugs including CDDP]. ![]() |
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| 20 | Comparative Clinical Trial of Granisetron and Ondansetron in the Prophylaxis of Cisplatin-Induced Emesis ![]() |
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| 21 | Use of dexamethasone and granisetron in the control of delayed emesis for patients who receive highly emetogenic chemotherapy. National Cancer Institute of Canada Clinical Trials Group. ![]() |
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| 22 | The role of the 5-HT3 antagonists ondansetron and dolasetron in the control of delayed onset nausea and vomiting in patients receiving moderately emetogenic chemotherapy. ![]() |
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| 23 | Dexamethasone Alone or in Combination with Ondansetron for the Prevention of Delayed Nausea and Vomiting Induced by Chemotherapy ![]() |
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| 24 | Potential of substance P antagonists as antiemetics. ![]() |
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| 25 | Brain penetration of aprepitant, a substance P receptor antagonist, in ferrets. ![]() |
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