Clinical therapeutics
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Clinical therapeutics · Nov 1995
Randomized Controlled Trial Multicenter Study Comparative Study Clinical TrialOndansetron for nausea and vomiting associated with moderately emetogenic cancer chemotherapy.
This multicenter, randomized, double-blind study compared the efficacy and tolerability of ondansetron 8 mg twice daily for 3 days with placebo in preventing nausea and vomiting in 81 patients receiving cyclophosphamide-doxorubicin-based chemotherapy. The first dose of study drug was administered 30 minutes before the initiation of chemotherapy. Patients received a rescue antiemetic if the investigator deemed it necessary or if the patient experienced more than two emetic episodes during the 3-day study. ⋯ The most common adverse event was headache, occurring in 23% of ondansetron patients and 24% of placebo patients. This study is the first double-blind, placebo-controlled trial to demonstrate that ondansetron 8 mg twice daily is effective in the prevention of nausea and vomiting associated with cyclophosphamide-doxorubicin-based chemotherapy. The twice-daily regimen may encourage patient compliance and may be more cost-effective than regimens that need to be given three times daily.