SAFETY TRIAL WITH THE 5HT(1B 1D) AGONIST AVITRIPTAN (BMS-180048) IN PATIENTS WITH MIGRAINE WHO HAVE EXPERIENCED PRESSURE, TIGHTNESS, AND/ORPAIN IN THE CHEST, NECK, AND/OR THROAT FOLLOWING SUMATRIPTAN/

We investigate whether symptoms of pressure, tightness, and/or pain in the chest, neck, and/or throat after administration of the 5HT(1B/1D) agonist avitriptan were associated with objective impairment of the m yocardial function on 12-lead electrocardiogram (ECC), continuous ECG (Wolter) monitoring, and echocardiography. Migraine sufferers who in t wo-thirds of all attacks treated with sumatriptan had experienced ches t/throat/neck symptoms were chosen for study. Baseline measures includ ed vital signs, a 12-lead ECG and an echocardiogram. Patients (n=51) w ho had no clinically significant abnormality at baseline received a hi gh dose (150 mg) of avitriptan orally outside of a migraine attack. If pressure, tightness, and/or pain. in the chest, neck, and/or throat o ccurred, an ECG was obtained, and a repeat echocardiogram was done whi le the symptoms were present in order to monitor for impairment of myo cardial function. If symptoms of these types did not occur within 60 m in after administration of the study drug, a second echocardiogram was obtained. Forty-five patients (88%) reported at least one adverse eve nt and 23 (45%) experienced pressure, tightness, and/or pain in the ch est, neck, and/or throat after administration of avitriptan. No clinic ally significant myocardial abnormalities were observed in any patient , even in those who had experienced the targeted symptoms. No other se rious adverse event occurred. We concluded that the typical 5HT(1B/1D) agonist-induced chest/throat/neck symptoms are most unlikely to be of cardiovascular origin.