Efficacy, tolerability and safety of oral eletriptan and ergotamine plus caffeine (Cafergot) in the acute treatment of migraine: a multicentre, randomised, double-blind, placebo-controlled comparison
Diener HC, Jansen JP, Reches A, Pascual J, Pitei D, Steiner TJ, Eletriptan and Cafergot Comparative Study Group
European neurology · 79 citas
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Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación no declarada
Publicación
- Publicado
- 2002-01-01 · Eur Neurol · vol. 47 · número 2 · págs. 99–107
- Editorial
- Karger Publishers
- Citado
- 123 citas · más que el 97% de estudios similares · 7.1× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 16 trabajos
- Acceso
- De pago
- Áreas de investigación
- Migraine and Headache Studies · Intracranial Aneurysms: Treatment and Complications · Nausea and vomiting management
- Palabras clave
- eletriptan, ergotamine, caffeine, migraine, acute migraine treatment, 5-HT1 receptor agonists, nausea, photophobia, phonophobia, functional disability, tolerability, drug safety, dose comparison, migraine with aura, migraine without aura, placebo comparison, adverse events, headache-related disability, migraine disability
- MeSH
- humans, tryptamines, ergotamine, pyrrolidines, indoles, caffeine, drug combinations, treatment outcome, double-blind method, dose-response relationship, drug, adolescent, adult, aged, middle aged, female, male, migraine disorders, serotonin receptor agonists
6 autores
- Hans‐Christoph Diener🇩🇪University of Duisburg-Essen
- Jan‐Peter Jansen
- Avinoan Reches🇮🇱Hadassah Medical Center
- Julio Pascual🇪🇸Marqués de Valdecilla University Hospital
- Daniela Pitei🇺🇸Pfizer (United States)
- Timothy J. Steiner🇬🇧Imperial College London
Resumen
El texto original del estudio, en el idioma en que se publicó.
The 5-HT(1B/1D/1F) agonist eletriptan, at an oral dose of 80 mg, has been shown to be more efficacious than sumatriptan 100 mg and placebo in the treatment of migraine attacks with or without aura. Another commonly prescribed oral treatment for migraine attacks is Cafergot (1 mg ergotamine tartrate with 100 mg caffeine per tablet). The efficacy, tolerability and safety of 40- and 80-mg doses of eletriptan and 2 tablets of Cafergot were compared in a double-blind, randomised, placebo-controlled, parallel-group trial involving 733 migraine patients. Patients recorded symptoms at baseline (before treatment) and 1, 2, 4 and 24 h after dosing. Headache intensity was assessed on a 4-point scale (3 = severe pain, 2 = moderate pain, 1 = mild pain, 0 = no pain). Significantly more eletriptan-treated patients (80 mg, 68%; 40 mg, 54%) than Cafergot-treated patients (33%; p < 0.001) reported headache response (improvement from moderate-to-severe to mild or no pain) at 2 h. Substantially more eletriptan recipients reported no pain (80 mg, 38%; 40 mg, 28%; Cafergot, 10%; placebo, 5%; p < 0.001). Eletriptan headache response rates at 1 h were significantly higher (80 mg, 39%; 40 mg, 29%; Cafergot, 13%; placebo, 13%; p < 0.002 for each comparison). Both doses of eletriptan were significantly more effective than Cafergot in reducing nausea (p < 0.0001), photophobia (80 mg, p < 0.0001; 40 mg, p < 0.002), phonophobia (80 mg, p < 0.0001; 40 mg, p < 0.003) and functional impairment (p < or = 0.001) at 2 h. Adverse events were generally mild or moderate and transient. This randomised trial shows that oral eletriptan is more efficacious in the acute treatment of migraine than oral Cafergot and is well tolerated.
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