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Early (≤ 1-h) vs. late (>1-h) administration of frovatriptan plus dexketoprofen combination vs. frovatriptan monotherapy in the acute treatment of migraine attacks with or without aura: a post hoc analysis of a double-blind, randomized, parallel group study.

Abstract
The early use of triptan in combination with a nonsteroidal anti-inflammatory drug after headache onset may improve the efficacy of acute migraine treatment. In this retrospective analysis of a randomized, double-blind, parallel group study, we assessed the efficacy of early or late intake of frovatriptan 2.5 mg + dexketoprofen 25 or 37.5 mg (FroDex 25 and FroDex 37.5) vs. frovatriptan 2.5 mg alone (Frova) in the acute treatment of migraine attacks. In this double-blind, randomized parallel group study 314 subjects with acute migraine with or without aura were randomly assigned to Frova, FroDex 25, or FroDex 37.5. Pain free (PF) at 2-h (primary endpoint), PF at 4-h and pain relief (PR) at 2 and 4-h, speed of onset at 60, 90, 120 and 240-min, and sustained pain free (SPF) at 24-h were compared across study groups according to early (≤1-h; n = 220) or late (>1-h; n = 59) intake. PF rates at 2 and 4-h were significantly larger with FroDex 37.5 vs. Frova (early intake, n = 71 FroDex 37.5 and n = 75 Frova: 49 vs. 32 % and 68 vs. 52 %, p < 0.05; late intake, n = 20 Frodex 37.5, and n = 18 Frova: 55 vs. 17 %, p < 0.05 and 85 vs. 28 %, p < 0.01). Also with FroDex 25, in the early intake group (n = 74) PF episodes were significantly higher than Frova. PR at 2 and 4-h was significantly better under FroDex 37.5 than Frova (95 % vs. 50 %, p < 0.001, 100 % vs. 72 %, p < 0.05) in the late intake group (n = 21). SPF episodes at 24-h after early dosing were 25 % (Frova), 45 % (FroDex 25) and 41 % (FroDex 37.5, p < 0.05 combinations vs. monotherapy), whereas they were not significantly different with late intake. All treatments were equally well tolerated. FroDex was similarly effective regardless of intake timing from headache onset.
AuthorsGianni Allais, Gennaro Bussone, Vincenzo Tullo, Pietro Cortelli, Fabio Valguarnera, Piero Barbanti, Giuliano Sette, Fabio Frediani, Giacomo D'Arrigo, Florindo d'Onofrio, Giancarlo Comi, Marcella Curone, Bruno Colombo, Stefano Omboni, Chiara Benedetto
JournalNeurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology (Neurol Sci) Vol. 36 Suppl 1 Pg. 161-7 (May 2015) ISSN: 1590-3478 [Electronic] Italy
PMID26017535 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Anti-Inflammatory Agents, Non-Steroidal
  • Carbazoles
  • Serotonin Receptor Agonists
  • Tryptamines
  • Tromethamine
  • Ketoprofen
  • frovatriptan
  • dexketoprofen trometamol
Topics
  • Anti-Inflammatory Agents, Non-Steroidal (administration & dosage)
  • Carbazoles (administration & dosage)
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Drug Therapy, Combination
  • Female
  • Follow-Up Studies
  • Humans
  • Ketoprofen (administration & dosage, analogs & derivatives)
  • Male
  • Migraine Disorders (drug therapy)
  • Pain Measurement
  • Serotonin Receptor Agonists (administration & dosage)
  • Time Factors
  • Treatment Outcome
  • Tromethamine (administration & dosage)
  • Tryptamines (administration & dosage)

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