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Efficacy, safety and tolerability of oral eletriptan in the acute treatment of migraine: results of a phase III, multicentre, placebo-controlled study across three attacks.

Abstract
The efficacy, safety and tolerability of the 5-HT1B/D receptor agonist eletriptan (40 mg and 80 mg) in acute treatment of migraine was evaluated in a multinational, randomized, double-blind, parallel-group, placebo-controlled, three-attack study treating 1153 patients. In the initial attack, significantly more eletriptan patients reported headache relief and complete pain relief at 2 h vs. placebo (40 mg 62% and 32%, 80 mg 65% and 34%, placebo 19% and 3%; P < 0.0001). Headache relief occurred faster after eletriptan, with more patients at both doses reporting relief 30 min (P < 0.01) and 1 h (P < 0.0001) after treatment than after placebo. There was a significantly lower recurrence rate with eletriptan 80 mg compared with placebo (P < 0.01). Adverse events for all treatments were generally mild or moderate and self-limiting. Eletriptan 40 mg and eletriptan 80 mg both appear to be effective and well-tolerated acute migraine treatments.
AuthorsR Stark, C Dahlöf, S Haughie, J Hettiarachchi, Eletriptan Steering Committee
JournalCephalalgia : an international journal of headache (Cephalalgia) Vol. 22 Issue 1 Pg. 23-32 (Feb 2002) ISSN: 0333-1024 [Print] England
PMID11993610 (Publication Type: Clinical Trial, Clinical Trial, Phase III, Comparative Study, Evaluation Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • HTR1B protein, human
  • Indoles
  • Pyrrolidines
  • Receptor, Serotonin, 5-HT1B
  • Receptor, Serotonin, 5-HT1D
  • Receptors, Serotonin
  • Serotonin Receptor Agonists
  • Tryptamines
  • eletriptan
Topics
  • Administration, Oral
  • Adolescent
  • Adult
  • Aged
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Female
  • Humans
  • Indoles (administration & dosage, adverse effects)
  • Male
  • Middle Aged
  • Migraine Disorders (drug therapy)
  • Pain Measurement
  • Pyrrolidines (administration & dosage, adverse effects)
  • Receptor, Serotonin, 5-HT1B
  • Receptor, Serotonin, 5-HT1D
  • Receptors, Serotonin
  • Serotonin Receptor Agonists (administration & dosage, adverse effects)
  • Treatment Outcome
  • Tryptamines

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