in the oral ondansetron 32-mg once-a-day group.
In a second trial, efficacy of the oral ondansetron 24-mg once-a-day regimen in the prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin ≥50 mg/m 2, was confirmed.
Moderately Emetogenic Chemotherapy
In 1 double-blind US study in 67 patients, ondansetron HCl tablets 8 mg administered twice a day were significantly more effective than placebo in preventing vomiting induced by cyclophosphamide-based chemotherapy containing doxorubicin. Treatment response is based on the total number of emetic episodes over the 3-day study period. The results of this study are summarized in Table 5.
Table 5: Emetic Episodes: Treatment Response After Ondansetron HCl Tablets 8 mg Twice A Day Ondansetron Tablet 8 mg twice Dailya Placebo p Value
Number of patients 33 34
a The first dose was administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. An 8 mg ondansetron HCl tablet was administered twice a day for 2 days after completion of chemotherapy.
b Median undefined since at least 50% of the patients were withdrawn or had more than 2 emetic episodes.
c Median undefined since at least 50% of patients did not have any emetic episodes.
Treatment response
0 emetic episodes 20 (61%) 2 (6%) <0.001
1-2 emetic episodes 6 (18%) 8 (24%)
>2 emetic episodes/ withdrawn 7 (21%) 24 (71%) <0.001
Median number of emetic episodes 0.0 Undefinedb
Median time to first emetic episode (h) Undefinedc 6.5
In 1 double-blind US study in 336 patients, ondansetron HCl tablets 8 mg administered twice a day were as effective as ondansetron HCl tablets 8 mg administered 3 times a day in preventing nausea and vomiting induced by cyclophosphamide-based chemotherapy containing either methotrexate or doxorubicin.
Treatment response is based on the total number of emetic episodes over the 3-day study period. The results of this study are summarized in Table 6.
Table 6: Emetic Episodes: Treatment Response After Ondansetron HCl Tablets 8 mg Twice A Day and Three Times A Day Ondansetron 8 mg twice Dailya Ondansetron 8 mg three times Dailyb
Number of patients 165 171
a The first dose was administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. An 8 mg ondansetron HCl tablet was administered twice a day for 2 days after completion of chemotherapy.
b The first dose was administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. An 8 mg ondansetron HCl tablet was administered 3 times daily for 2 days after completion of chemotherapy.
c Median undefined since at least 50% of patients did not have any emetic episodes.
d Visual analog scale assessment: 0=no nausea, 100=nausea as bad as it can be.
Treatment response
0 emetic episodes 101 (61%) 99 (58%)
1-2 emetic episodes 16 (10%) 17 (10%)
>2 emetic episodes/withdrawn 48 (29%) 55 (32%)
Median number of emetic episodes 0.0 0.0
Median time to first emetic episode (h) Undefinedc Undefinedc
Median nausea scores (0-100)d 6 6
Retreatment
In uncontrolled trials, 148 patients receiving cyclophosphamide-based chemotherapy were re-treated with ondansetron HCl tablets 8 mg three times daily d |
