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document
Comparison of single-dose oral granisetron versus intravenous ondansetron in the prevention of nausea and vomiting induced by moderately emetogenic chemotherapy : a multicenter , double-blind , randomized parallel study . PURPOSE The antiemetic effectiveness and safety of single-dose oral granisetron were compared with intravenous ( I.V . ) ondansetron in chemotherapy-naive patients who received moderately emetogenic chemotherapy . PATIENTS AND METHODS In this double-blind , parallel-group study , patients naive to emetogenic chemotherapy ( N = 1,085 ) who were scheduled to receive cyclophosphamide- ( 500 to 1,200 mg/m2 ) or carboplatin ( > or = 300 mg/m2 ) based chemotherapy , were randomized to receive either oral granisetron ( n = 542 ) or I.V . ondansetron ( n = 543 ) . Efficacy assessments included the proportion of patients in each treatment group with total control over the 24 and 48 hours following chemotherapy initiation , as well as incidence and severity of nausea and emesis and use of antiemetic rescue medication . Prophylactic corticosteroids were allowed . Safety assessment was based on patients ' reports of adverse experiences . RESULTS Approximately 80 % of patients received prophylactic corticosteroids . Single-dose oral granisetron ( 2 mg ) and I.V . ondansetron ( 32 mg ) resulted in equivalent levels of total emetic control during the first 48 hours after chemotherapy . The proportion of nausea- and emesis-free patients at 24 and 48 hours were also approximately equivalent . The most commonly reported adverse experiences were headache , asthenia , and constipation . More patients who received ondonsetron than granisetron reported dizziness ( 9.6 % v 5.4 % , respectively ; P = .011 ) and abnormal vision ( 4.2 % v 0.6 % , respectively ; P < .001 ) . CONCLUSION A single oral dose of granisetron ( 2 mg ) resulted in equivalent levels of antiemetic protection as I.V . ondansetron ( 32 mg ) . Both agents were well tolerated , although more dizziness and abnormal vision were reported with ondansetron . Because the two antiemetic regimens exhibited equivalent efficacies , additional factors such as convenience and cost of therapy should be considered .
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Intervention_Pharmacological
granisetron
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Intervention_Pharmacological
ondansetron
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Intervention_Pharmacological
granisetron
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Intervention_Pharmacological
ondansetron
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Intervention_Physical
moderately emetogenic chemotherapy
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Intervention_Physical
emetogenic chemotherapy
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Intervention_Pharmacological
cyclophosphamide- ( 500 to 1,200 mg/m2 )
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Intervention_Pharmacological
carboplatin
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Intervention_Pharmacological
granisetron
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Intervention_Pharmacological
ondansetron
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Intervention_Control
treatment group
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Intervention_Control
control
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Intervention_Physical
chemotherapy
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Intervention_Pharmacological
Prophylactic corticosteroids were allowed
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Intervention_Pharmacological
prophylactic corticosteroids
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Intervention_Pharmacological
granisetron
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Intervention_Pharmacological
ondansetron
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Intervention_Physical
chemotherapy
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Intervention_Pharmacological
ondonsetron
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Intervention_Pharmacological
granisetron
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Intervention_Pharmacological
granisetron
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Intervention_Pharmacological
ondansetron
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Intervention_Pharmacological
ondansetron
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Outcome_Adverse-effects
nausea and emesis
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Outcome_Adverse-effects
total emetic control
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Outcome_Adverse-effects
proportion of nausea- and emesis-free patients
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Outcome_Adverse-effects
headache , asthenia , and constipation .
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Outcome_Adverse-effects
dizziness
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Outcome_Adverse-effects
abnormal vision
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Outcome_Adverse-effects
antiemetic protection
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Outcome_Adverse-effects
dizziness and abnormal vision
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Participant_Condition
chemotherapy-naive patients who received moderately emetogenic chemotherapy .
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Participant_Condition
parallel-group study , patients naive to emetogenic chemotherapy ( N = 1,085 ) who were scheduled to receive cyclophosphamide- ( 500 to 1,200 mg/m2 ) or carboplatin ( > or = 300 mg/m2 ) based chemotherapy