A MULTICENTER, DOUBLE-BLIND COMPARISON OF IV AND ORAL-ADMINISTRATION OF ONDANSETRON PLUS DEXAMETHASONE FOR ACUTE CISPLATIN-INDUCED EMESIS

A total of 530 patients were treated in this multicenter, double-blind , double-dummy, parallel group study to compare the anti-emetic effica cy and safety of a once daily ondansetron oral regimen with a once dai ly i.v. dosing regimen over a 24 h period, administered to patients pr ior to receiving cisplatin (50 mg/m(2) or greater) chemotherapy. Patie nts were randomized to receive a single dose of ondansetron plus dexam ethasone given either orally (ondansetron 24 mg and dexamethasone 12 m g, n=262) or i.v. (ondansetron 8 mg and dexamethasone 20 mg, n=268). C omplete control of emesis (i.e. no emetic episodes, no rescue and no p remature withdrawal) was achieved for 85% of patients (224 of 262) in the oral group and 83% (223 of 268) in the i.v. group. No nausea was r eported in 70% of patients in the oral group and 68% in the i.v. group . There were no statistically significant differences between the two groups for any of the assessments of efficacy, which included time to first emetic episode, number of emetic episodes and the worst grade of nausea occurring over the 24 h study period. Once daily ondansetron o ral and i.v., in combination with dexamethasone, was well tolerated in this study, In conclusion, once daily oral ondansetron 24 mg plus dex amethasone is equally effective in the control of emesis and nausea in duced by highly emetogenic chemotherapy as once daily ondansetron 8 mg i.v. plus dexamethasone. [(C) 1998 Lippincott Williams & Wilkins.].