IS NAVOBAN(R) (TROPISETRON) AS EFFECTIVE AS ZOFRAN(R) (ONDANSETRON) IN CISPLATIN-INDUCED EMESIS

The purpose of this study was to evaluate and com pare the antiemetic effectiveness and tolerability of Navoban(R)(tropisetron) and Zofran(R) (ondansetron) following high-dose (greater than or equal to 50 mg/m(2)) cisplatin chemotherapy. In a randomised, multicentre, double-biind, double-dummy, parallel group study, 117 evaluable chemotherapy-naive patients who received Navoban(R) were compared with 114 who received Zofran(R). Patient diary cards were used to assess both acute (Day 1) and delayed (Days 2-6) nausea and vomiting. Total control of acute vomiting was achieved in 54% of Navoban(R) and 65% of Zofran(R) patients (p = 0.052), and total control of acute nausea in 66% and 62% respectively (p = 0.655). Total control of delayed vomiting was achieved in 44% of Navoban(R) patients and 46% of Zofran(R) patients (p = 0.765), and of delayed nausea in 56% and 47% respectively (p = 0.207). Bath reactions combined were totally prevented during the entire 6-day trial period in 22% of Navoban(R) and 24% of Zofran(R) patients (NS), while a further 42% of patients in both groups remained largely free from both nausea and emesis. The few adverse reactions (e.g. headache, constipation, diarrhoea) were mainly mild and typical of the 5-HT3-receptor antagonists. In conclusion, there were no significant differences in efficacy and tolerability between Navoban(R) 5 mg once daily and the highest recommended dose of Zofran(R) (32 mg on Day 1, followed by 8 mg three times a day).