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.