Comparison of the selective serotonin(3) antagonists ramosetron and granisetron in treating acute chemotherapy-induced emesis, nausea, and anorexia: A single-blind, randomized, crossover study

Background: Ramosetron, a new specific Ei-hydroxytryptamine (5HT(3))-recept or antagonist, is 58 times more potent than granisetron, and its antiemetic effect lasts 10.7 times longer than that of granisetron in ferrets treated with cisplatin. Objective: This study was undertaken to compare the duration of efficacy an d the safety profile of the selective 5HT(3)-receptor antagonists ramosetro n and granisetron in treating acute chemotherapy-induced emesis, nausea, an d anorexia. Methods: This single-blind, randomized, crossover, 3-site study compared a single intravenous (IV) infusion of ramosetron 0.3 mg with a single IV infu sion of granisetron 3 mg 15 minutes before infusion of chemotherapy in male and female cancer patients aged 14 to 75 years. Patients were assessed for 24 hours after the start of chemotherapy infusion. Response criteria for e mesis were as follows: completely effective, moderately effective, slightly effective, and not effective. Response criteria for nausea were as follows : moderately effective, slightly effective, and not effective. Anorexia was graded as mild, moderate, severe, or nonexistent. The severity of these ev ents and their relationship to study treatment were assessed by the investi gator. Results: A total of 111 patients were enrolled in the study. Data from 98 a nd from 110 patients were used to assess efficacy and safety, respectively. The ability of ramosetron to prevent emesis, nausea, and anorexia was simi lar to that of granisetron up to 6 hours after administration of chemothera py, but from 18 to 24 hours after therapy ramosetron was significantly more effective than granisetron against nausea (P = 0.003) and anorexia (P = 0. 04). The 2 drugs had a similar safety profile, and adverse events were gene rally mild and transient. Conclusions: The efficacy and safety profile of ramosetron are similar to t hose of granisetron, but ramosetron appears to have a longer duration of ac tion than does granisetron.