A randomized, double-blind, parallel, comparative study to evaluate the efficacy and safety of ramosetron plus dexamethasone injection for the prevention of acute chemotherapy-induced nausea and vomiting.

OBJECTIVE To evaluate the efficacy of intravenous ramosetron plus dexamethasone for the prevention of acute chemotherapy-induced nausea and vomiting. METHODS Cancer patients scheduled to receive chemotherapy containing either of the four drugs (cisplatin, doxorubicin, epirubicin or oxaliplatin) were enrolled. They were randomized to receive intravenous ramosetron 0.3 mg plus dexamethasone 20 mg or granisetron 3 mg plus dexamethasone 20 mg 30 min before chemotherapy on day 1. The primary efficacy parameter is complete response rate, which was defined by the proportion of patients without vomiting and no requirement for rescue drugs within 24 h after chemotherapy. RESULTS A total of 285 patients were enrolled. The primary efficacy analysis included 274 patients. The complete response rate was 77.37% in the ramosetron 0.3 mg plus dexamethasone 20 mg group (137 patients) and 81.75% in the granisetron 3 mg plus dexamethasone 20 mg group (137 patients) with a difference of -4.38% (95% confidence interval: -14.64, 5.89). Therefore, non-inferiority of ramosetron 0.3 mg plus dexamethasone 20 mg to granisetron 3 mg plus dexamethasone 20 mg was demonstrated with non-inferiority margin -15%. For patients treated with cisplatin, non-inferiority of ramosetron 0.3 mg plus dexamethasone 20 mg to granisetron 3 mg plus dexamethasone 20 mg could not be demonstrated. Only a few patients required rescue medications, 7.3% in the ramosetron 0.3 mg plus dexamethasone 20 mg group and 5.1% in the granisetron 3 mg plus dexamethasone 20 mg group (P = 0.44). All 285 patients were included for safety analysis; 36.11% (52/144) and 23.40% (33/141) experienced at least one adverse event within 24 h in the ramosetron 0.3 mg plus dexamethasone 20 mg and granisetron 3 mg plus dexamethasone 20 mg groups, respectively. Four ramosetron-related adverse events among 144 patients were observed including two moderate elevation of liver enzymes and one each of mild hiccup and moderate skin rash. CONCLUSIONS The combination of ramosetron plus dexamethasone was an effective treatment to prevent acute chemotherapy-induced nausea and vomiting.