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 < or = 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 < or = 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 < or = 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 < or = 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 < or = 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 < or = 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 > or = 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%).

• Authors: Suzanne Christie, Hartmut Göbel, Valentin Mateos, Christopher Allen, France Vrijens, Malathi Shivaprakash, Rizatriptan-Ergotamine/Caffeine Preference Study Group
• Journal: European neurology (Eur Neurol) Vol. 49 Issue 1 Pg. 20-9 ( 2003) ISSN: 0014-3022 [Print] Switzerland
• PMID: 12464714 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright 2003 S. Karger AG, Basel

Chemical References

• Drug Combinations
• Serotonin Receptor Agonists
• Triazoles
• Tryptamines
• Caffeine
• rizatriptan
• Ergotamine

Topics

• Adolescent
• Adult
• Aged
• Caffeine (adverse effects, therapeutic use)
• Cross-Over Studies
• Double-Blind Method
• Drug Combinations
• Ergotamine (adverse effects, therapeutic use)
• Female
• Humans
• Male
• Middle Aged
• Migraine Disorders (drug therapy)
• Pain Measurement
• Patient Satisfaction
• Serotonin Receptor Agonists (adverse effects, therapeutic use)
• Triazoles (adverse effects, therapeutic use)
• Tryptamines