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 / Journal of the Korean Cancer Association, 대한암학회지

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.

The use of 5-hydroxytryptamine (5HT) receptor antagonist after percutaneous transluminal angioplasty in infrapopliteal arteriosclerotic occlusive disease / 中华普通外科杂志

Objective To evaluate a 5HT receptor antagonist sarpogrelate hydrochloride after percutaneous transluminal angioplasty (PTA) in infrapopliteal arteriosclerotic occlusive disease.Methods From June 2010 to June 2012,105 (116 limbs) patients of infrapopliteal arteriosclerosis obliterans treated by PTA were divided randomly into two groups:treatment group (58 cases,64 limbs)and control group(47 cases,52 limbs).All patients were treated with aspirin and clopidogrel for 3 months.Patients in treatment group were treated with additional sarpogrelate hydrochloride.Intermittent claudication,rest pain,amputation rate,ABI,vascular prosthesis obstructing degree were assessed.Results 95 patients were followed up for 6 months,the intermittent claudication rate in treatment group and control group were 3.8％ and 16.3％ (P ＜ 0.05); while there was not different on 1,3 months,in the intermittent claudication rate and 1,3,6 months,in rest pain rate,amputation rate,target artery patency rate and ABI between the two groups (P ＞ 0.05).There was one bleeding event in treatment group (1.7％).Conclusions 5HT receptor antagonist (sarpogrelate hydrochloride) significantly improves intermittent claudication after PTA in infrapopliteal arteriosclerotic occlusive disease,and its use is safe with aspirin and clopidogrel.