A double-blind, randomized, multicenter, Italian study of frovatriptan versus rizatriptan for the acute treatment of migraine

J Headache Pain. 2011 Apr;12(2):219-26. doi: 10.1007/s10194-010-0243-y. Epub 2010 Aug 5.

Abstract

The objective of this study was to assess patient satisfaction with acute treatment of migraine with frovatriptan or rizatriptan by preference questionnaire. 148 subjects with a history of migraine with or without aura (IHS 2004 criteria), with at least one migraine attack per month in the preceding 6 months, were enrolled and randomized to frovatriptan 2.5 mg or rizatriptan 10 mg treating 1-3 attacks. The study had a multicenter, randomized, double-blind, cross-over design, with treatment periods lasting <3 months. At the end of the study, patients assigned preference to one of the treatments using a questionnaire with a score from 0 to 5 (primary endpoint). Secondary endpoints were pain-free and pain relief episodes at 2 h, and recurrent and sustained pain-free episodes within 48 h. 104 of the 125 patients (83%, intention-to-treat population) expressed a preference for a triptan. The average preference score was not significantly different between frovatriptan (2.9±1.3) and rizatriptan (3.2±1.1). The rates of pain-free (33% frovatriptan vs. 39% rizatriptan) and pain relief (55 vs. 62%) episodes at 2 h were not significantly different between the two treatments. The rate of recurrent episodes was significantly (p<0.001) lower under frovatriptan (21 vs. 43% rizatriptan). No significant differences were observed in sustained pain-free episodes (26% frovatriptan vs. 22% rizatriptan). The number of patients with adverse events was not significantly different between rizatriptan (34) and frovatriptan (25, p=NS). The results suggest that frovatriptan has a similar efficacy to rizatriptan, but a more prolonged duration of action.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Carbazoles / pharmacology*
  • Carbazoles / therapeutic use
  • Double-Blind Method
  • Drug Administration Schedule
  • Female
  • Humans
  • Italy
  • Male
  • Middle Aged
  • Migraine Disorders / drug therapy*
  • Serotonin Receptor Agonists / pharmacology*
  • Serotonin Receptor Agonists / therapeutic use
  • Triazoles / pharmacology*
  • Triazoles / therapeutic use
  • Tryptamines / pharmacology*
  • Tryptamines / therapeutic use
  • Young Adult

Substances

  • Carbazoles
  • Serotonin Receptor Agonists
  • Triazoles
  • Tryptamines
  • rizatriptan
  • frovatriptan