Headache Response Rates Research Articles

Zolmitriptan is Effective for the Treatment of Persistent and Recurrent Migraine Headache

SummaryZolmitriptan is a 5-HTIB/ID 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 5mg zolmitriptan for the treatment of persistent migraine headache, two hours after an initial dose of 2.5mg 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 2.5mgor5mg 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 5mg 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 5mg 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 5mg, 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.

Zolmitriptan, a 5-HT1B/1D receptor agonist for the acute oral treatment of migraine: a multicentre, 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 attacks. Of 1181 patients randomized, 840 were evaluable for the primary efficacy analysis. Headache response rates (a reduction in headache intensity 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 zolmitriptan recipients (16% placebo). At 2 hours post dose, 39-47% of zolmitriptan-treated patients were pain-free, compared with 1% of placebo recipients. 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 placebo recipients. Zolmitriptan was well tolerated at each dose. The most commonly reported adverse events were asthenia, dizziness, paraesthesia and feelings of heaviness. Most adverse events were of mild or moderate intensity and were transient. The frequency of adverse events was dose-related. Although, zolmitriptan 5 mg exhibited the most favourable efficacy and tolerability profile, the dose response data suggest that lower doses would also offer significant efficacy. Copyright 1998 Lippincott Williams & Wilkins

Zolmitriptan:a new acute treatment for migraine

Zolmitriptan is a new oral acute treatment for migraine. It is a selective and potent agonist at the serotonin (5-HT)1B/1D receptor and was developed to improve on the oral bioavailability, tissue selectivity and CNS penetration of earlier compounds. Animal studies confirmed that these objectives had been attained. In man, zolmitriptan is rapidly absorbed after oral administration, with at least 75% of the eventual Cmax reached within 1 h. Oral bioavailability is approximately 40%. The elimination half-life of zolmitriptan is approximately 2.5 h and the primary route of elimination is metabolism, with one of the metabolites being pharmacologically active. A consistent 2-h headache response rate of 60 - 70% was observed at doses of 2.5 mg and above. Long-term treatment response is high (> 80%) and consistent. In addition, there is evidence from electrophysiology in migraineurs that zolmitriptan has a central action not shared by sumatriptan. Zolmitriptan is well-tolerated. The nature and incidence of the most frequently reported adverse events are similar to those of other 5-HT1B/1D agonists. Long-term zolmitriptan usage was associated with an improvement in quality of life. Zolmitriptan is a suitable first-line drug for acute treatment for migraine.

The Long‐term Tolerability and Efficacy of Oral Zolmitriptan (Zomig, 31X90) in the Acute Treatment of Migraine. An International Study

This international open‐label study evaluated the tolerability and efficacy of zolmitriptan (Zomig®, 311C90), a selective 5‐HT1B/1D receptor agonist in the long‐term treatment of multiple migraine attacks. Patients who had previously participated in placebo‐controlled zolmitriptan studies were recruited. A total of 2058 patients treated 31 579 migraine 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 induded asthenia (14% of patients), nausea (12%), somnolence (10%), dizziness (11%), and paresthesia (11%). The rank order of the most common adverse events was not influenced by sex, age, or number of zolmitriptan doses taken and was similar between attacks 1 and 45. The majority of adverse events (59%) occurred within 2 hours of dosing, were of either mild (59%) or moderate (35%) intensity, of 4 hours' duration or less (67%), and required no further 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 posttreatment) 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 age, sex, weight, use of prophylactic antimigraine medication, or association of attacks with menstruation. Analysis of the overall population and a subgroup who treated 30 or more migraine attacks showed that zolmitriptan 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% and 78% of moderate and severe attacks, respectively. Patients treated recurrence of moderate or severe headache with a second zolmitriptan dose in 32% of attacks which responded to the first dose within 2 hours. Where required, a second zolmitriptan 5‐mg dose for treatment of recurrence produced a headache response rate of 90% at 2 hours postdose. Thus, zolmitriptan 5 mg (plus an optional second 5‐mg dose for treatment of recurrence) is well tolerated and effective in the acute treatment of multiple migraine attacks over periods up to 1 year.