THE LONG-TERM TOLERABILITY AND EFFICACY OF ORAL ZOLMITRIPTAN (ZOMIG, 311C90) IN THE ACUTE TREATMENT OF MIGRAINE - AN INTERNATIONAL STUDY

This international open-label study evaluated the tolerability and eff icacy of zolmitriptan (Zomig(R), 311C90), a selective 5-HT1B/1D recept or agonist, in the long-term treatment of multiple migraine attacks. P atients who had previously participated in placebo-controlled zolmitri ptan studies were recruited. A total of 2058 patients treated 31 579 m igraine attacks (average 15 per patient), for up to 1 year. Twenty-six percent of attacks treated with a single zolmitriptan 5-mg dose were associated with at least one adverse event (24% treated with two doses ). The most frequent adverse events included asthenia (14% of patients ), nausea (12%), somnolence (10%), dizziness (11%), and paresthesia (1 1%). The rank order of the most common adverse events was not influenc ed by sex, age, or number of zolmitriptan doses taken and was similar between attacks 1 and 45. The majority of adverse events (59%) occurre d within 2 hours of dosing, were of either mild (59%) or moderate (35% ) intensity, of 4 hours' duration or less (67%), and required no furth er action (94%). Following an initial 5-mg dose of zolmitriptan, the 2 -hour headache response rate (reduction in headache pain from moderate or severe before treatment to mild or no pain at 2 hours posttreatmen t) was 81% in patients treating moderate and severe attacks (19 639 of 24 161). Patients were pain-free at 2 hours in 55% of all attacks (16 510 of 29 808). The efficacy of zolmitriptan was not influenced by ag e, sex, weight, use of prophylactic antimigraine medication, or associ ation of attacks with menstruation. Analysis of the overall population and a subgroup who treated 30 or more migraine attacks showed that zo lmitriptan was consistently effective across attacks. Overall, 67% of patients who treated five or more attacks reported zolmitriptan to be effective in 80% to 100% of attacks. Zolmitriptan produced meaningful migraine relief and improvement in normal activity impairment in 73% a nd 78% of moderate and severe attacks, respectively. Patients treated recurrence of moderate or severe headache with a second zolmitriptan d ose in 32% of attacks which responded to the first dose within 2 hours . Where required, a second zolmitriptan 5-mg dose for treatment of rec urrence produced a headache response rate of 90% at 2 hours postdose. Thus, zolmitriptan 5 mg (plus an optional second 5-mg dose for treatme nt of recurrence) is well tolerated and effective in the acute treatme nt of multiple migraine attacks over periods up to 1 year.