Optimizing the dose of zolmitriptan (Zomig,* 311C90) for the acute treatment of migraine

Abstract

This study investigated the efficacy of zolmitriptan (Zomig, formerly 311C90) in acute migraine therapy. Patients with a history of migraine were randomized in a double-blind, multicenter, placebo-controlled, dose range-finding study of oral zolmitriptan 1, 2.5, 5, or 10 mg versus placebo for the treatment of a severe or moderate migraine headache. Patients with persistent or recurrent headache 4 to 24 hours after the initial dose, who did not take escape medication, were eligible to receive a second blinded dose of either zolmitriptan or placebo. Of 1,144 patients treated, 999 evaluable patients completed the study. The headache response rates with zolmitriptan doses > or = 2.5 mg were 44 to 51% at 1 hour, 65 to 67% at 2 hours, and 75 to 78% at 4 hours (all significantly superior to placebo). Also, zolmitriptan effectively relieved migraine-associated symptoms such as nausea, photophobia and phonophobia, and reduced activity impairment. Rates of headache recurrence, headache persistence, and use of escape medication were lower with zolmitriptan doses > or = 2.5 mg than with placebo. In patients with persistent or recurrent headache, a second zolmitriptan dose effectively treated both headache and nonheadache symptoms. Zolmitriptan was well tolerated, with a lower incidence of adverse events being reported with doses < or = 2.5 mg than with those > or = 5 mg. Zolmitriptan is a well tolerated and effective acute migraine therapy providing rapid relief of migraine headache within 1 hour. A clear dose-response relationship between efficacy and tolerability suggests that 2.5 mg is the optimal initial dose for the acute treatment of a migraine attack.

A Review of the Pharmacokinetics, Pharmacodynamics and Efficacy of Zolmitriptan in the Acute Abortive Treatment of Migraine

“…Finally, the mean 24 hour headache recurrence rate is 30% for the 2.5 mg tablet and 31% for and the zolmitriptan 5 mg tablet as compared to 38% and 48% for the placebo, Figure 3 and 4. 43,[63][64][65] There is also evidence of a consistent response across multiple attacks in individual patients for both, the 2.5 mg and 5 mg tablets of zolmitriptan. Tuchman et al showed that the 2-hour headache response across attacks was 85% for the 2.5 mg tablet and 79% for the 5 mg zolmitriptan tablet.…”

“…The effi cacy of zolmitriptan tablets has been demonstrated in multiple double-blind placebo controlled trials. 43,[63][64][65] At 2 hours, the mean headache response (HR) rate is approximately 64% for the 2.5 mg zolmitriptan tablet as compared to 35% for placebo; similarly the 2 hr HR rate is 65% for the zolmitriptan 5 mg tablets as compared to 27% for placebo. In addition the mean 2 hour pain free (PF) rate was 24.5% for the 2.5 mg zolmitriptan tablet and 28.6% for the 5 mg tablet, as compared to the placebo 2 hr PF rates of 8.5% and 4.3% respectively.…”

Sumatriptan 6 mg subcutaneous as an effective migraine treatment in patients with cutaneous allodynia who historically fail to respond to oral triptans

“…Improved response to triptan medications may occur through several methods. One of these would be to increase the dose of the oral triptan [8,9]. Another approach would be to use a SC route of administration of the drug as is available for sumatriptan.…”

Menstrual migraine

“…However parenteral administration of the non-selective 5-HT1 agonist dihydroergotamine (DHE) was significantly more effective than placebo for this condition [11]. Sumatriptan [12], zolmitriptan [13], rizatriptan [14] and naratriptan [15] have also been shown effective for aborting attacks of menstrual migraine, and also for relieving the associated nausea and vomiting.…”