Sumatriptan, a specific 5-hydroxytryptamine agonist, is a novel acute
treatment for migraine. The efficacy and safety profiles of sumatripta
n have previously been demonstrated in several controlled short-term s
tudies. However, because migraine is a recurrent disorder which may pe
rsist throughout adult life, sustained efficacy and tolerability are e
ssential if sumatriptan is to be of value in clinical practice. These
aspects were therefore evaluated in a programme of three 12-month stud
ies. Sustained efficacy with long-term use of single 100-mg oral doses
has been demonstrated in an open study in which 288 patients treated
8,094 migraine attacks. The long-term safety profile of oral and subcu
taneous sumatriptan has been evaluated in a total of 849 patients who
treated 24,907 migraine attacks in studies lasting up to 1 year. Sumat
riptan was well tolerated. Adverse events did not differ qualitatively
or quantitatively from those in short-term studies, irrespective of t
he frequency of attacks or the number of doses used. Migraine attacks
were effectively treated with doses less than the recommended maximum
and there was no evidence of any adverse effect on attack frequency. I
n long-term studies the high efficacy of sumatriptan is maintained, an
d the adverse event profile is unchanged and unaffected by attack freq
uency.