A double-blind randomized study comparing intramuscular (i.m.) granisetronwith i.m. granisetron plus dexamethasone in the prevention of delayed emesis induced by cisplatin

Granisetron has been shown to exert a beneficial therapeutic effect in the prophylaxis and treatment of acute nausea and vomiting clue to chemotherapy . However, limited data regarding its efficacy in the prevention and treatm ent of delayed emesis are available. A total of 532 patients entered this m ulticenter double-blind study, aimed at comparing the efficacy and safety o f intramuscular (i.m.) granisetron with that of i.m. granisetron plus dexam ethasone. Complete response and total control were evaluated for 3 days fol lowing the first 24 h after cisplatin administration in two groups of patie nts: 262 treated with granisetron 3 mg i.m. daily (plus placebo), and 265 w ith granisetron at the same dose plus dexamethasone 8 and 4 mg twice daily. The rate of complete response was 58.0% in the granisetron group and 78.9% in the granisetron plus dexamethasone group over days 1-3 (p<0.01). Simila rly, over the same period total control was 44.7% with granisetron alone an d 65.3% with granisetron plus dexamethasone (p<0.01). Local and systemic to lerability of the i.m. therapy with granisetron were satisfactory. In concl usion, granisetron plus dexamethasone showed good protection against delaye d emesis due to emetogenic chemotherapy. [(C) 1999 Lippincott Williams & Wi lkins.].