Crossover Comparison of Efficacy and Preference for Rizatriptan 10 mg versus Ergotamine/Caffeine in Migraine

Abstract

Rizatriptan is a selective 5-HT_1B/1D receptor agonist with rapid oral absorption and early onset of action in the acute treatment of migraine. This randomized double- blind crossover outpatient study assessed the preference for 1 rizatriptan 10 mg tablet to 2 ergotamine 1 mg/caffeine 100 mg tablets in 439 patients treating a single migraine attack with each therapy. Of patients expressing a preference (89.1%), more than twice as many preferred rizatriptan to ergotamine/caffeine (69.9 vs. 30.1%, p ≤ 0.001). Faster relief of headache was the most important reason for preference, cited by 67.3% of patients preferring rizatriptan and 54.2% of patients who preferred ergotamine/caffeine. The co-primary endpoint of being pain free at 2 h was also in favor of rizatriptan. Forty-nine percent of patients were pain free 2 h after rizatriptan, compared with 24.3% treated with ergotamine/caffeine (p ≤ 0.001), rizatriptan being superior within 1 h of treatment. Headache relief at 2 h was 75.9% for rizatriptan and 47.3% for ergotamine/caffeine (p ≤ 0.001), with rizatriptan being superior to ergotamine/caffeine within 30 min of dosing. Almost 36% of patients taking rizatriptan were pain free at 2 h and had no recurrence or need for additional medication within 24 h, compared to 20% of patients on ergotamine/caffeine (p ≤ 0.001). Rizatriptan was also superior to ergotamine/caffeine in the proportions of patients with no nausea, vomiting, phonophobia or photophobia and for patients with normal function 2 h after drug intake (p ≤ 0.001). More patients were (completely, very or somewhat) satisfied 2 h after treatment with rizatriptan (69.8%) than at 2 h after treatment with ergotamine/caffeine (38.6%, p ≤ 0.001). Recurrence rates were 31.4% with rizatriptan and 15.3% with ergotamine/caffeine. Both active treatments were well tolerated. The most common adverse events (incidence ≧5% in one group) after rizatriptan and ergotamine/caffeine, respectively, were dizziness (6.7 and 5.3%), nausea (4.2 and 8.5%) and somnolence (5.5 and 2.3%).

Rizatriptan vs. ibuprofen in migraine: a randomised placebo-controlled trial

“…Amongst the triptans, oral rizatriptan has been reported to be more effective than sumatriptan, naratriptan and zolmitriptan [8]. In a cross-over study, rizatriptan was found to be superior to ergotamine and caffeine combination in relieving acute migraine attack [9]. The decision to choose a new drug is based not only on its efficacy compared to placebo but also its relative advantage over other available drugs.…”

Rizatriptan for the acute treatment of migraine: Consistency, preference, satisfaction, and quality of life

“…Most of the studies were financially sponsored by Merck Frosst, the maker of rizatriptan. 3,4,[6][7][8]10,[12][13][14][15] This bias likely resulted in the preference comparison of rizatriptan to the 50 mg dose of sumatriptan, rather than the 100 mg dose, which may be more effective than the lower dose of sumatriptan in some patients. 26 Furthermore, most studies compared only two attacks -one attack for each medication -which may not be enough time to determine whether a medication is effective and well tolerated.…”

“…12 Two hours after dosing, 69.8% of patients were completely, very or somewhat satisfied with rizatriptan, compared to 38.6% with ergotamine/caffeine (p  0.001).…”

“…Rizatriptan 10 mg tablet was compared with two ergotamine 1 mg/caffeine 100 mg tablets in a study of 439 patients. 12 . 89.1% of patients expressed a preference.…”

Patient preference in migraine therapy

“…Patient preference is a patient-focused, composite outcome that incorporates efficacy, onset of action, duration of efficacy, consistency, tolerability and convenience of formulation [8]. Although patient preference is a subjective measurement, it addresses the central issue of which therapy is best for an individual patient and reflects how a particular treatment option is perceived by each patient with migraine [9].…”