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Early Treatment of Migraine With Rizatriptan: A Placebo‐Controlled Study
Author(s) -
Mathew Ninan T.,
Kailasam Jayasree,
Meadors Lori
Publication year - 2004
Publication title -
headache: the journal of head and face pain
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.14
H-Index - 119
eISSN - 1526-4610
pISSN - 0017-8748
DOI - 10.1111/j.1526-4610.2004.04125.x
Subject(s) - rizatriptan , migraine , placebo , medicine , sumatriptan , alternative medicine , receptor , pathology , agonist
Objective.—To evaluate the efficacy of rizatriptan when administered early during a migraine attack. Background.—Several studies indicate that triptans are more efficacious when administered early during a migraine attack, when the pain is still mild. Methods.—One hundred and twelve rizatriptan‐naïve patients aged 20 to 64 years with a history of migraine with or without aura that progressively worsened when left untreated were instructed to treat a total of three migraine attacks with either rizatriptan 10 mg or placebo as early as possible during each attack. Seventy‐four patients (68 women and 6 men) were assigned to use the active drug and 38 (35 women and 3 men) to placebo. The primary efficacy endpoint was pain‐free response at 2 hours after administration of the study drug. Secondary efficacy measures were pain‐free response at 1 hour and sustained pain‐free response lasting between 2 and 24 hours. Results.—A total of 216 attacks were treated in the rizatriptan group and 109 in the placebo group. Pain‐free response at 2 hours after early treatment was noted in 151 (70%) of attacks in the rizatriptan group and in 24 (22%) in the placebo group ( P < .01). Pain‐free response at 1 hour occurred in 97 (45%) and 9 (8%) attacks, respectively ( P < .01). When the attacks were categorized by headache severity at the time of treatment, the pain‐free response at 2 hours was higher for mild attacks than for moderate or severe attacks ( P < .01). Sustained pain‐free response after treatment was significantly higher for attacks treated with rizatriptan (60%) than for those treated with placebo (17%) ( P < .001). Adverse events were observed in 62 patients in the rizatriptan group and 15 in the placebo group. Only 1 patient taking rizatriptan discontinued the study because of adverse events, and no serious adverse events were reported. Conclusions.—Rizatriptan is significantly more likely than placebo to produce a pain‐free response within 2 hours when the drug is administered early in the migraine attack, when pain is mild rather than moderate or severe.