Ho, C.L., Su, W.C., Hsieh, R.K., Lin, Z.Z., & Chao, T.Y. (2010). 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. Japanese Journal of Clinical Oncology, 40, 294–301.
To evaluate the efficacy of IV ramosetron plus dexamethasone compared to granisetron plus dexamethasone for the prevention of acute chemotherapy-induced nausea and vomiting (CINV)
Subjects were randomized to receive 0.3 mg ramosetron plus 20 mg dexamethasone or 3 mg granisetron plus 20 mg dexamethasone on day 1 prior to chemotherapy. Patients were evaluated over a 24-hour period. All vomiting episodes were recorded by the patient. Every 6 hours, the degree of nausea was evaluated.
The study was conducted at multiple sites in Taiwan.
All patients were in active treatment.
This was a randomized trial (double-blind), parallel group trial.
Complete response (CR) was defined as no vomiting and no rescue medication. The date, time, and number of episodes of vomiting or retching were recorded. Patients rated their levels of nausea using a 10-cm visual analog scale (VAS) tool. Total control was defined as no vomiting and nausea rating of less than 0.5 cm on the VAS tool. A proportion of subjects received rescue drugs.
Ramosetron plus dexamethasone regimen was found to be equivalent to granisetron plus dexamethasone in CR rate during the acute phase.
Ramosetron plus dexamethasone regimen was found to be as effective as granisetron plus dexamethasone in the management of CINV during the acute phase, suggesting that ramosetron could be used as an alternative to other 5-HT3 receptor antagonists in highly and moderately emetogenic chemotherapy.