Speaker: Andrew Dowson, MD, Director of the Headache Clinic, Kings College Hospital, London, United Kingdom.
Six-month follow-up results from a large-scale phase III clinical study demonstrate that zolmitriptan nasal spray (Zomig®, AstraZeneca) 5 mg is safe, well tolerated, and reliably effective when used for the long-term acute treatment of multiple migraine attacks. High pain-free rates have been maintained over time.
To assess the spray’s long-term safety and tolerability as well as its efficacy at 5 mg, investigators enrolled 538 patients aged 18 to 65 years of age with a diagnosis of migraine, as defined by the International Headache Society. This open-label, non-comparative study was conducted in 52 centers in Canada, Finland, Germany, South Africa, Sweden, and the United Kingdom. The patients had endured at least three migraine headaches per month in the previous three months.
Patients with headache of any baseline pain intensity—mild, moderate, or severe—were given zolmitriptan nasal spray and a second dose of trial medication; patients with persistent or recurrent headache could take an “escape” medication at more than two hours after the initial dose.
The study population of 538 patients had treated themselves for more than one migraine attack, for a total of 20,717 treated attacks. There was a high rate of treated attacks; 43.9% of patients treated a mean of three or more attacks per month for at least six months. Over the course of the 20,717 attacks treated, ADEs were reported in 85.3% of patients; however, patients reported only 32.8% of the attacks.
The most commonly reported ADEs were unusual taste in 19% of patients and paresthesias in 6.8% of patients. Overall, only 24 patients withdrew from the study because of ADEs.
Patients used a second dose of zolmitriptan nasal spray 5 mg at least two hours after the initial dose to treat 5,101 attacks. The use of two 5-mg doses to treat an individual attack did not change the type, frequency, or maximum intensity of ADEs. buy cialis soft tabs
As for efficacy, 53.8% of the 20,717 treated attacks were recorded as pain-free at two hours following treatment. This outcome was maintained throughout the study, and the pain-free rates at two hours were consistent over the four 90-day periods of the study: 51.2% for days 0 to 90; 52.7%, for days 91 to 180; 55.8°% for days 181 to 270; and 55.7°% for days 271 to 360.
The high efficacy of zolmitriptan nasal spray was not affected by the presence of rhinitis. Two-hour pain-free rates for each 90-day period ranged from 54.4% to 56.6% for attacks treated in the presence of rhinitis.
Levetiracetam for Transformed Migraine
Speaker: Alan M. Rapaport, MD, Co-Director of the New England Center for Headache, Stamford, Connecticut, and Clinical Professor of Neurology, Columbia University College of Physicians and Surgeons, New York.
A prospective, open-label study shows that the antiepileptic agent levetiracetam (Keppra®, UCB Pharma) significantly reduces the frequency and impact of headaches in patients with transformed (chronic, daily) migraine.
Overall, 36 patients (26 women, 10 men; average age, 46.5 years) were enrolled into a prospective, open-label study of levetiracetam for the preventive treatment of refractory transformed migraine. All the participants had previously been unresponsive to one, but not more than three, preventive drugs and had taken no more than one antiepileptic drug. Eleven patients were not using other preventive drugs at the time of enrollment into the study.
After a baseline evaluation, patients received levetiracetam 250 mg/day and increased the dose by 250 mg every fifth day, up to a dose of 1,000 mg daily. After the first month, doses could be further increased to 3,000 mg/day in two divided doses. The treatment phase lasted three months.
The primary endpoint was headache frequency. Secondary endpoints included:
These primary and secondary endpoints were assessed at baseline and at monthly intervals.
The median headache frequency at baseline was 24.9 days of headaches per month. Three months of treatment with levetiracetam reduced this number by 35%—to 16.2 days of headaches per month. The average number of moderate or severe days of headache decreased by 42%, from 16.8 days per month to 9.7 days per month, after three months of levetira-cetam therapy.
After three months of levetiracetam treatment, MIDAS scores were also significantly reduced by 35% (from 62.8 to 40.8) and HIT scores declined by 6.0% (from 63.4 to 59.4).
Fifteen patients reported drug-related ADEs. Eight patients dropped out of the study because of side effects, although no serious effects were reported.