A comparative study of the use of granisetron, a selective 5-HT3 antagonist, versus a standard anti-emetic regimen of chlorpromazine plus dexamethasone in the treatment of cytostatic-induced emesis. The Granisetron Study Group.

Patients with cancer were randomized in single-blind fashion to receive either granisetron (n = 114) or a conventional anti-emetic combination of chlorpromazine and dexamethasone (n = 113) as prophylactic agents against the nausea and vomiting induced by a number of designated cytostatic drugs. In the first 24 h, 70% of patients in the granisetron group remained free from vomiting and had no, or only mild nausea compared with 49% of patients in the comparator group, a significant improvement over the conventional anti-emetic (P = 0.0013). Significantly fewer adverse events were reported in the granisetron group (P less than 0.05) and treatment did not result in the somnolence reported by patients receiving chlorpromazine plus dexamethasone (P less than 0.05). In the conventional treatment group, initial infusions were maintained with oral chlorpromazine at 4-6 h intervals in the first 24 h. Ten per cent of these patients received alternative, rescue anti-emetics during this period. In the granisetron group, 70% of patients received only a single prophylactic dose of 40 micrograms/kg granisetron throughout the 7-day period. During the first 24 h, 20% of patients in the granisetron group received up to two additional 40 micrograms/kg doses of granisetron and 6% received rescue anti-emetics.

RCT Entities:   Population Interventions Outcomes