Pain-free rates with zolmitriptan 2.5 mg ODT in the acute treatment of migraine: results of a large double-blind placebo-controlled trial

ABSTRACT

Context: 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.

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

Setting: Outpatient headache clinics in the US.

Patients: 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).

Intervention: 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.

Main outcome measure: 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.

Key words: :

• Efficacy
• Migraine
• Orally disintegrating tablet
• Tolerability
• Zolmitriptan

Notes

* Material in this manuscript has previously been presented in preliminary, unpublished form at the following meetings: 6th Congress of the European Federation of Neurological Societies, Vienna, Austria, 26–29 Oct 2002; 55th Annual Meeting of the American Academy of Neurology, Hawaii, USA, 29 Mar – 5 April 2003