Efficacy of Rizatriptan 10 mg administered early in a migraine attack.
OBJECTIVE
To determine if administration of rizatriptan 10 mg is superior to placebo for the early treatment of acute migraine, while the pain is mild.


BACKGROUND
Past studies have suggested that treatment outcomes can be improved if a triptan is administered early in the time course of a migraine attack.


METHODS
Two randomized, parallel, placebo-controlled, double-blind studies. TAME (Treat A Migraine Early)1 was conducted at 46 centers in the United States; TAME2, at 48 centers in the United States. Totally, 1030 adult patients with at least a 6-month history of migraine were studied. Patients were instructed to treat within 1 hour of migraine onset, while pain was mild. Patients maintained a headache diary in which they rated their levels of pain and disability, and recorded other symptoms of migraine. Primary endpoints were pain freedom at 2 hours and sustained pain freedom at 24 hours post-dose.


RESULTS
In TAME1, 57.3% versus 31.1% of patients reported pain freedom at 2 hours post-dose and 42.6% versus 23.2% reported 24-hour sustained pain freedom with rizatriptan versus placebo, respectively (P < .001 for both). In TAME2, 58.9% versus 31.1% of patients reported pain freedom at 2 hours post-dose and 48.0% versus 24.6% reported 24-hour sustained pain freedom with rizatriptan versus placebo, respectively (P < .001 for both). All other efficacy endpoints favored rizatriptan. Repeat doses of the medicine were not allowed; patients may have delayed treatment; non-migraine headaches may have been treated.


CONCLUSIONS
Rizatriptan 10 mg was superior to placebo when treating migraine early, while pain is mild, as measured by pain freedom at 2 hours and 24-hour sustained pain freedom.
Cady
Roger
R
Primary Care Network, 3805 S. Kansas Expressway, Springfield, MO 65807, USA.
Martin
Vincent
V
Mauskop
Alexander
A
Rodgers
Anthony
A
Hustad
Carolyn M
CM
Ramsey
Karen E
KE
Skobieranda
Franck
F
D000208:Acute Disease; D000328:Adult; D005260:Female; D006801:Humans; D008297:Male; D008499:Medical Records; D008881:Migraine Disorders / Q000188:drug therapy*; D017060:Patient Satisfaction; D017366:Serotonin Receptor Agonists / Q000008:administration & dosage* / Q000009:adverse effects; D012720:Severity of Illness Index; D013997:Time Factors; D014230:Triazoles / Q000008:administration & dosage* / Q000009:adverse effects; D014363:Tryptamines / Q000008:administration & dosage* / Q000009:adverse effects
D017366:Serotonin Receptor Agonists; D014230:Triazoles; D014363:Tryptamines; C093622:rizatriptan