ZOLMITRIPTAN, A 5-HT1B 1D RECEPTOR AGONIST FOR THE ACUTE ORAL TREATMENT OF MIGRAINE - A MULTICENTER, DOSE-RANGE FINDING STUDY/

Zolmitriptan is a selective 5-HT1B/1D receptor agonist for acute oral migraine therapy. This randomized, placebo-controlled, parallel-group study investigated the efficacy and tolerability of oral zolmitriptan (5, 10, 15 and 20 mg) in the treatment of single acute migraine attack s. Of 1181 patients randomized, 840 were evaluable for the primary eff icacy analysis. Headache response rates (a reduction in headache inten sity from severe or moderate at baseline to mild or no pain at 2 hours post-treatment) were similar across the zolmitriptan dose groups (66% , 71%, 69% and 77% for 5 mg, 10 mg, 15 mg and 20 mg, respectively) and were significantly higher than that for placebo (19%; all groups P < 0.001). A headache response was reported at 1 hour by 40-50% of zolmit riptan recipients (16% placebo). At 2 hours post dose, 39-47% of zolmi triptan-treated patients were pain-free, compared with 1% of placebo r ecipients. Headache recurrence occurred in 21-29% (upper 95% CI 37.1) of zolmitriptan-treated patients and in 65% (95% CI 38.3, 85.8) of pla cebo recipients. Zolmitriptan was well tolerated at each dose. The mos t commonly reported adverse events were asthenia, dizziness, paraesthe sia and feelings of heaviness. Most adverse events were of mild or mod erate intensity and were transient. The frequency of adverse events wa s dose-related. Although, zolmitriptan 5 mg exhibited the most favoura ble efficacy and tolerability profile, the dose response data suggest that lower doses would also offer significant efficacy. Eur J Neurol 5 :535-543 (C) 1998 Lippincott Williams & Wilkins.