title: Early treatment of migraine with rizatriptan: a placebo-controlled study.
abstract: 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.
authors.affiliation: Houston Headache Clinic, Texas 77004, USA.
authors.forename: Ninan T
authors.initials: NT
authors.lastname: Mathew
authors.forename: Jayasree
authors.initials: J
authors.lastname: Kailasam
authors.forename: Lori
authors.initials: L
authors.lastname: Meadors
mesh_terms: D000328:Adult; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D008881:Migraine Disorders / Q000145:classification / Q000188:drug therapy*; D010147:Pain Measurement; D017366:Serotonin Receptor Agonists / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome; D014230:Triazoles / Q000627:therapeutic use*; D014363:Tryptamines
chemical_list: D017366:Serotonin Receptor Agonists; D014230:Triazoles; D014363:Tryptamines; C093622:rizatriptan