Objective. To examine the short and long term efficacy and tolerabilty of rizatriptan 5 mg in adolescents with migraine. Methods. Two studies were condu cted in patients aged 12 to 17 years. The first study was a rand...Objective. To examine the short and long term efficacy and tolerabilty of rizatriptan 5 mg in adolescents with migraine. Methods. Two studies were condu cted in patients aged 12 to 17 years. The first study was a randomized, double blind, placebo controlled, single attack study followed by a randomized, 1 ye ar, open label extension. The second study was a randomized, 1 year, open lab el study. In the single attack study, patients treated a moderate or severe mig raine headache and up to two recurrences with rizatriptan 5-mg tablets (n = 234 ) or placebo (n = 242). Patients were instructed to use the study medication onl y on nonschool days. Headache severity, associated symptoms, and functional disa bility were assessed by the patient at 0.5,1, 1.5, 2, 3, and 4 hours after the i nitial dose. In the 1 year studies, patients treated up to 6 migraine attacks p er month with rizatriptan 5-mg tablets (n = 273), rizatriptan 5-mg wafers (n = 281), or standard care therapy (n = 132). Headache severity was assessed by the patient at 2 hours after the initial dose. In all studies, the primary efficacy measure was pain relief at 2 hours post dose. Results. In the single attack study, the proportion of patients with pain relief at 2 hours was not significan tly different between rizatriptan 5 mg (68.2%) and placebo (68.8%). Fewer pat ients than expected (about 30%) treated their migraine attacks on the weekend. Among these patients, the proportion with pain relief at 2 hours was significant ly higher in the rizatriptan group than in the placebo group (74%vs. 58%, P = 0.022). In the multiple attack studies, pain relief at 2 hours was achieved in significantly more attacks treated with rizatriptan 5-mg tablet (77%) or with rizatriptan 5-mg wafer (77%) than with standard care (64%). Rizatriptan 5 mg was well tolerated in both the studies, with an adverse event profile not signif icantly different from that of placebo or standard care. Conclusions. Rizatrip tan 5 mg was not more effective than placebo in the treatment of a single migrai ne attack in adolescents, but appeared to be more effective than standard care f or treating multiple attacks occurring over 1 year in these patients. Rizatripta n 5 mg was well tolerated in adolescents during short term and long term use.展开更多
文摘Objective. To examine the short and long term efficacy and tolerabilty of rizatriptan 5 mg in adolescents with migraine. Methods. Two studies were condu cted in patients aged 12 to 17 years. The first study was a randomized, double blind, placebo controlled, single attack study followed by a randomized, 1 ye ar, open label extension. The second study was a randomized, 1 year, open lab el study. In the single attack study, patients treated a moderate or severe mig raine headache and up to two recurrences with rizatriptan 5-mg tablets (n = 234 ) or placebo (n = 242). Patients were instructed to use the study medication onl y on nonschool days. Headache severity, associated symptoms, and functional disa bility were assessed by the patient at 0.5,1, 1.5, 2, 3, and 4 hours after the i nitial dose. In the 1 year studies, patients treated up to 6 migraine attacks p er month with rizatriptan 5-mg tablets (n = 273), rizatriptan 5-mg wafers (n = 281), or standard care therapy (n = 132). Headache severity was assessed by the patient at 2 hours after the initial dose. In all studies, the primary efficacy measure was pain relief at 2 hours post dose. Results. In the single attack study, the proportion of patients with pain relief at 2 hours was not significan tly different between rizatriptan 5 mg (68.2%) and placebo (68.8%). Fewer pat ients than expected (about 30%) treated their migraine attacks on the weekend. Among these patients, the proportion with pain relief at 2 hours was significant ly higher in the rizatriptan group than in the placebo group (74%vs. 58%, P = 0.022). In the multiple attack studies, pain relief at 2 hours was achieved in significantly more attacks treated with rizatriptan 5-mg tablet (77%) or with rizatriptan 5-mg wafer (77%) than with standard care (64%). Rizatriptan 5 mg was well tolerated in both the studies, with an adverse event profile not signif icantly different from that of placebo or standard care. Conclusions. Rizatrip tan 5 mg was not more effective than placebo in the treatment of a single migrai ne attack in adolescents, but appeared to be more effective than standard care f or treating multiple attacks occurring over 1 year in these patients. Rizatripta n 5 mg was well tolerated in adolescents during short term and long term use.
