Abstract
In a double-blind, placebo-controlled study, the efficacy, safety and tolerability of 100 mg oral sumatriptan, given as a dispersible tablet, was compared with that of 900 mg oral aspirin plus 10 mg oral metoclopramide in the acute treatment of migraine. A total of 358 patients treated up to three migraine attacks within 3 months, recording clinical information on a diary card. In attack 1, headache relief after 2 h, defined as a reduction in severity from severe or moderate pain to mild or no pain, was recorded in 56% (74/133) of patients who took sumatriptan and 45 % (62/138) of patients who took aspirin plus metoclopramide (p = 0.078). This analysis of the primary efficacy end point was not statistically significant. However, for attacks 2 and 3 (secondary end points), headache relief was achieved in 58 versus 36% of patients (p = 0.001) and 65 versus 34% of patients (p < 0.001), respectively. Relief from nausea, vomiting, photophobia and phonophobia was similar in both treatment groups. Rescue medication was required by fewer patients treated with sumatriptan than by those who received aspirin plus metoclopramide (attack 1, 34 versus 56%, p < 0.001; attack 2, 32 versus 51 %, p = 0.001, and attack 3, 35 versus 54%, p = 0.001). Sumatriptan also produced a faster improvement and resolution of migraine attacks. Comparing the sumatriptan and aspirin plus metoclopramide treatment groups, complete resolution of the attack occurred within 6 h in 32 versus 19% (attack 1), 35 versus 23% (attack 2) and 32 versus 20% of patients (attack 3). There was, however, a lower incidence of headache recurrence within 48 h in patients who received aspirin plus metoclopramide: attack 1, 42 % on sumatriptan versus 33% on aspirin plus metoclopramide (NS); attack 2, 37 versus 27% (NS), and attack 3, 42 versus 30% (p = 0.038). Adverse events were reported by 42 % of patients on sumatriptan and 29% of patients on aspirin plus metoclopramide (p = 0.009), but these were generally mild or moderate. Treatment was rated as reasonable, good or excellent by 66 % of patients in the sumatriptan group, compared with 45% of those in the aspirin plus metoclopramide group (p < 0.001). Moreover, 70% of sumatriptan-treated patients said they would be prepared to take the treatment again, compared with 46% of patients who received aspirin plus metoclopramide (p < 0.001). Overall, oral sumatriptan produced faster and greater relief of migraine headache and was more highly rated by patients than oral aspirin plus oral metoclopramide.