Zolmitriptan is a 5-HT1B/1D receptor agonist for the acute treatment of
migraine. This study examined the efficacy of a second dose of
zolmitriptan for the treatment of persistent or recurrent
headache. Part 1 was a randomised, placebo-controlled, double-blind evaluation of 2.5 mg and 5 mg
zolmitriptan for the treatment of persistent
migraine headache, two hours after an initial dose of 2.5 mg
zolmitriptan. In part 2 (open-label), patients treated the first two attacks with 2.5 mg
zolmitriptan, thereafter patients could treat any initial, persistent or recurrent
migraine headache with 2.5 mg or 5 mg
zolmitriptan. The unique design of this trial allowed patients to adjust their treatment to attain maximum
headache relief and control of their disease. Of 2800 patients treating an initial
migraine headache in Part 1, 989 patients took a second dose to treat persistent
headache of moderate or severe intensity.
Headache response rates were similar across the three treatment groups, but the
pain-free response rate was significantly higher with 5 mg
zolmitriptan than with placebo (p < 0.001). In Part 2, 2499 patients treated 49,784
migraine attacks (excluding the first two attacks, which had to be treated with 2.5 mg
zolmitriptan), of which 66% required only a single dose of
zolmitriptan. Patients treated 22% of attacks with a second dose of
zolmitriptan for persistent
headache. A
headache response was achieved in 80% and 73% of persistent
headaches treated with 2.5 mg or 5 mg
zolmitriptan, respectively. Corresponding
pain-free responses following treatment of persistent
headaches of any intensity were 64% and 52%. Eight per cent of attacks were treated with a second dose of
zolmitriptan for moderate or severe recurrent
headache. A
headache response was achieved in 90% and 86% of moderate/severe attacks, with a
pain-free response in 78% and 70% of attacks of any intensity treated with 2.5 mg and 5 mg, respectively.
Zolmitriptan was well tolerated. In conclusion, 2.5 mg and 5 mg
zolmitriptan are highly effective in treating both persistent and recurrent
migraine headache.