The efficacy and safety of oral
sumatriptan as a 100-mg dispersible
tablet was compared with oral
Cafergot (2 mg
ergotamine tartrate, 200 mg
caffeine) in a multicentre, randomized, double-blind, double-dummy, parallel-group trial. In the trial, 580 patients were treated from 47 investigating centres in nine European countries.
Sumatriptan was significantly more effective than
Cafergot at reducing the intensity of
headache from severe or moderate to mild or none; 66% (145/220) of those treated with
sumatriptan improved in this way by 2 h, compared with 48% (118/246) of those treated with
Cafergot (p less than 0.001). The onset of
headache resolution was more rapid with
sumatriptan, whereas recurrence of
migraine headache within 48 h was lower with
Cafergot.
Sumatriptan was also significantly more effective at reducing the incidence of
nausea (p less than 0.001),
vomiting (p less than 0.01) and
photophobia/
phonophobia (p less than 0.001) 2 h
after treatment, and fewer patients on
sumatriptan (24%) than on
Cafergot (44%, p less than 0.001) required other medication after 2 h. The overall incidence of patients reporting adverse events was 45% after
sumatriptan and 39% after
Cafergot; the difference was not significant. The most commonly reported events in the
sumatriptan-treated patients were malaise or
fatigue and bad taste; these were generally mild and transient.
Nausea and/or
vomiting, abdominal discomfort, and
dizziness or
vertigo were reported by a greater proportion of
Cafergot-treated patients. It is concluded that oral
sumatriptan was well tolerated and is a more effective acute treatment for
migraine than
Cafergot.