A dose-finding study of granisetron, a novel antiemetic, in patients receiving cytostatic chemotherapy. The Granisetron Study Group.

The efficacy and safety of a novel antiemetic, granisetron, was assessed at two dose levels (40 micrograms/kg and 160 micrograms/kg) in a randomized, double-blind study of 504 patients undergoing treatment with a range of standard cytostatic therapies. In the first 24 h, 75% of patients in the lower-dose group and 81% in the higher were complete responders (i.e. experienced no vomiting and no, or only mild, nausea). Two additional doses of granisetron (40 micrograms/kg) were allowed on the first day to treat any symptoms of nausea and vomiting. This produced improvement or resolution of symptoms in 94% of patients in the lower-dose group and 97% of patients in the higher-dose group. Over the 7 days of the study a complete response was maintained by 56% of patients in each group. No differences in efficacy or safety between the two doses of granisetron were established. Granisetron was very well tolerated. The commonest adverse event was headache, occurring in about 15% of patients, which required no more than simple analgesia. No extrapyramidal effects were observed. There was no relationship between the total dose of granisetron and the number or severity of specific adverse events.

RCT Entities:   Population Interventions Outcomes