METHODS: This was a post hoc analysis derived from an open-label, multicenter, long-term study of the safety, tolerability, and efficacy of
almotriptan 12.5 mg. Patients who met International
Headache Society criteria for
migraine with or without
aura were eligible. Patients were instructed to take a single dose of
almotriptan 12.5 mg at the onset of a
migraine attack. Rescue medication could be taken if
migraine pain had not disappeared at 2 hours. A second dose of
almotriptan 12.5 mg could be taken if
head pain recurred within 24 hours of the initial dose. Patients reported the intensity of
pain at baseline and at 1 and 2 hours postmedication using a 4-point scale: no
pain, mild, moderate, or severe
pain. They also reported recurrence of
pain (return of moderate or severe
pain within 2 to 24 hours of taking the study medication) and use of rescue medication. Rescue medication consisted of supplemental
analgesics taken for
pain relief at 2 to 24 hours postdose.
Ergotamines and other 5-HT1B/1D agonists were excluded as rescue medications. Based on these patient-reported end points, sustained
pain-free rates, defined as
pain-free at 2 hours with no recurrence from 2 to 24 hours and no use of rescue medication, were calculated.
RESULTS: A higher proportion of
migraine attacks of mild intensity were
pain-free at 1 hour (35.3%) compared with attacks of moderate or severe intensity (7.5%) (P <.001). Two-hour
pain-free rates also were significantly higher with mild intensity
pain (76.9%) compared to moderate or severe intensity (43.9%) (P <.001). In addition, recurrence rates and use of rescue medication were reduced when attacks were treated during mild
pain. Recurrence was 12.9% for mild
pain versus 25.0% for moderate or severe
pain (P <.001), and use of rescue medication was 9.4% for mild
pain versus 17.2% for moderate or severe
pain (P <.001). Sustained
pain-free rates were nearly twice as high when attacks were treated during mild intensity
pain (66.6%) compared with attacks treated during moderate or severe
pain (36.6%) (P <.001).
CONCLUSION: