title: 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.
authors.affiliation: Department of Surgical Sciences, Women's Headache Center, University of Turin, Via Ventimiglia 3, 10126, Turin, Italy, gb.allais@tiscali.it.
authors.forename: Gianni
authors.initials: G
authors.lastname: Allais
authors.forename: Gennaro
authors.initials: G
authors.lastname: Bussone
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Tullo
authors.forename: Pietro
authors.initials: P
authors.lastname: Cortelli
authors.forename: Fabio
authors.initials: F
authors.lastname: Valguarnera
authors.forename: Piero
authors.initials: P
authors.lastname: Barbanti
authors.forename: Giuliano
authors.initials: G
authors.lastname: Sette
authors.forename: Fabio
authors.initials: F
authors.lastname: Frediani
authors.forename: Giacomo
authors.initials: G
authors.lastname: D'Arrigo
authors.forename: Florindo
authors.initials: F
authors.lastname: d'Onofrio
authors.forename: Giancarlo
authors.initials: G
authors.lastname: Comi
authors.forename: Marcella
authors.initials: M
authors.lastname: Curone
authors.forename: Bruno
authors.initials: B
authors.lastname: Colombo
authors.forename: Stefano
authors.initials: S
authors.lastname: Omboni
authors.forename: Chiara
authors.initials: C
authors.lastname: Benedetto
mesh_terms: D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage*; D002227:Carbazoles / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007660:Ketoprofen / Q000008:administration & dosage / Q000031:analogs & derivatives*; D008297:Male; D008881:Migraine Disorders / Q000188:drug therapy*; D010147:Pain Measurement; D017366:Serotonin Receptor Agonists / Q000008:administration & dosage*; D013997:Time Factors; D016896:Treatment Outcome; D014325:Tromethamine / Q000008:administration & dosage*; D014363:Tryptamines / Q000008:administration & dosage*
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D002227:Carbazoles; D017366:Serotonin Receptor Agonists; D014363:Tryptamines; D014325:Tromethamine; D007660:Ketoprofen; C108128:frovatriptan; C118296:dexketoprofen trometamol