ORAL ONDANSETRON-8-MG TWICE-DAILY IS AS EFFECTIVE AS 8-MG 3 TIMES DAILY IN THE PREVENTION OF NAUSEA AND VOMITING ASSOCIATED WITH MODERATELYEMETOGENIC CANCER-CHEMOTHERAPY

The efficacy and safety of ondansetron 8 mg BID compared with 8 mg TID for 3 days in the prevention of nausea and vomiting in 402 patients o n cyclophosphamide (greater than or equal to 500 mg/m(2))-based chemot herapy were evaluated in a multicenter, randomized, double-blind, stra tified study. The percentage of patients with no emetic episodes over the 3-day study period was 61% in the ondansetron BID group compared w ith 58% in the ondansetron TID group. Among patients with at least one emetic episode, the mean time to emesis was 14 hr and 17 min in the o ndansetron BID group compared with 12 hr and 48 min in the ondansetron TID group. Patients' daily appetite ratings and nausea scores were no t significantly different between groups. Clinical laboratory and adve rse event profiles were similar between groups. This study is the firs t large-scale, double-blind trial to demonstrate that ondansetron 8 mg BID for 3 days, a dosing regimen that may enhance patient convenience and compliance, is an effective as ondansetron 8 mg TID for 3 days in the prevention of nausea and vomiting associated with cyclophosphamid e-based chemotherapy.