Pain-free rates with zolmitriptan 2.5 mg ODT in the acute treatment of migraine: results of a large double-blind placebo- controlled trial.
BACKGROUND
Zolmitriptan 2.5 mg orally disintegrating tablets (ODT) allow patients to take the medication without fluids, which is convenient and avoids the risk of fluid-induced exacerbation of nausea/vomiting.


OBJECTIVE
To evaluate the efficacy and tolerability of zolmitriptan 2.5 mg ODT taken as soon as possible after onset of a migraine.


METHODS
Multicenter, double-blind, parallel-group, placebo-controlled two-attack trial.


METHODS
Outpatient headache clinics in the US.


METHODS
608 patients were randomized; 566 patients treated at least 1 migraine and were included in the tolerability assessment (565 patients were included in the intent-to-treat population).


METHODS
Patients were randomized to either zolmitriptan 2.5 mg ODT or placebo. Patients treated up to 2 migraine attacks as soon as possible after the start of their migraine pain.


METHODS
Pain-free rates at 2 h.


RESULTS
Zolmitriptan 2.5 mg ODT (n = 281) demonstrated a significant pain-free rate vs. placebo (n = 284) at 2 h (40% vs. 20%, p < 0.001), 1.5 h (25% vs. 15%, p < 0.001), and 1 h (13% vs. 8%, p = 0.004). Sustained pain-free rate was significantly higher than placebo (31% vs. 15%; p < 0.001). Return to normal activities favored zolmitriptan 2.5 mg ODT at 1 h (p = 0.004), 1.5 h (p < 0.001), and 2 h (p < 0.001). Adverse events associated with zolmitriptan 2.5 mg ODT were those commonly reported with the use of triptans.


CONCLUSIONS
Zolmitriptan 2.5 mg ODT, taken as early as possible after onset of a migraine attack, is effective in the treatment of migraine, producing a significantly higher pain-free rate than placebo 2 h post-dose, and also at the earlier time points of 1 h and 1.5 h post-dose.
Loder
Elizabeth
E
Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, MA, USA. eloder@partners.org
Freitag
Frederick G
FG
Adelman
James
J
Pearlmand
Starr
S
Abu-Shakra
Susan
S
D000208:Acute Disease; D000284:Administration, Oral; D000328:Adult; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D008881:Migraine Disorders / Q000188:drug therapy*; D023303:Oxazolidinones / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology* / Q000627:therapeutic use*; D010146:Pain / Q000188:drug therapy* / Q000209:etiology; D010919:Placebos; D017366:Serotonin Receptor Agonists / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology* / Q000627:therapeutic use*; D016896:Treatment Outcome; D014363:Tryptamines
D023303:Oxazolidinones; D010919:Placebos; D017366:Serotonin Receptor Agonists; D014363:Tryptamines; C089750:zolmitriptan