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 sample consisted of 285 participants.
• The mean age of participants was 51 years with a range of 22–74.
• The sample was 60.8% female and 38.2% male.
• Diagnoses were breast (43.2%) and lung (29.1%), as well as nasopharynx, mouth, rectum, liver, bladder, stomach, esophagus, testis, brain, and other.
• All patients were receiving emetogenic chemotherapy including cisplatin, doxorubicin, epirubicin, or oxaliplatin.
• Patients were not eligible if they had symptoms of vomiting for at least one week before study entry.

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.

• No difference was found between the ramosetron plus dexamethasone group and the granisetron plus dexamethasone in CR rates.
• No statistically significant differences were found in the proportions of patients with vomiting, nausea on the VAS scale, or rescue medication.
• No differences were found in drug-related adverse events between the two treatment arms.
• The most frequent adverse event reported was hiccups in both groups.
• Overall, 77.4% of patients receiving ramosetron and 82% of patients receiving granisetron achieved CR.

Ramosetron plus dexamethasone regimen was found to be equivalent to granisetron plus dexamethasone in CR rate during the acute phase.

• Patients receiving both highly and moderately emetogenic chemotherapy were combined, with no subgroup analysis for different levels of emetogenicity.
• Patient compliance with diary recording was not discussed

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.