The efficacy and tolerability of NOVOBAN (tropisentron) to prevent nausea and vomiting in patients treated with highly emetogenic chemotherapy (cisplatin, DTIC)

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Klin Onkol 1995; 8(3): 87-90.

Summary: In 1992-94 proceeded an open multicenter uncontrolled clinic study: ´The efficacy and tolerability of Navoban (tropisetron) to prevent nausea and vomiting in patients treated with highly emetogenic chemoterapy´. We have studied 40 patients, 23 males and 17 females, medium age 48,5 years (22-70). Patients received 5 mg Navoban in 100 ml normal saline in a 15 min. infusion immediately before the administration of chemotherapy. The day 2-6 they received one capsule of Navoban (5 mg) orally. Navoban was given as monodierapy. In first 24 hours after chemotherapy was 74,3 % patients without nausea and 83,8 % without vomiting. 1.3 % was bedridden due to nausea and 4 % was bedridden due to vomiting. In days 2-6 were 48,7 % patients without nausea and 67,6 % without vomiting and 1,6 % was bedridden due to nausea and 4 % to vomiting.

Tolerability was very good, only in one case the application of Navoban was interrupted due to the skin alergie reaction. In conclusion, Navoban (tropisetron) in monotherapy was safe and effective in controling acute emesis induced by cisplatin and DTIC containing chemotherapy when given at doses 1 x5 mg over 6 consecutive days.