Early
triptan use after
headache onset may help improve the efficacy of acute
migraine treatment. This may be particularly the case when
triptan therapy is combined with a nonsteroidal anti-inflammatory
drug (
NSAID). The objective of this is to assess whether the combination of
frovatriptan 2.5 mg +
dexketoprofen 25 or 37.5 mg (FroDex25 and FroDex37.5) is superior to
frovatriptan 2.5 mg alone (
Frova) in the acute treatment of
migraine attacks in patients who took the
drug within 30 min from the onset of
pain (early use) or after (late use). A total of 314 subjects with a history of
migraine with or without
aura were randomized into a double-blind, multicenter, parallel group, pilot study to
Frova, FroDex25 or FroDex37.5 and were required to treat at least one
migraine attack. In the present post hoc analysis, traditional
migraine endpoints were compared across study drugs for subgroups of the 279 patients of the full analysis set according to early (n = 172) or late (n = 107)
drug use. The proportion of patients
pain free at 2 h in the early
drug use subgroup was 33 % with
Frova, 50 % with FroDex25 and 51 % with FroDex37.5 mg (p = NS combinations vs. monotherapy), while in the late
drug use subgroup was 22, 51 and 50 % (p < 0.05 FroDex25 and FroDex37.5 vs.
Frova), respectively.
Pain-free episodes at 4 h were 54 % for early and 34 % for late use of
Frova, 71 and 57 % with FroDex25 and 74 and 68 % with FroDex37.5 (p < 0.05 for early and p < 0.01 for late use vs.
Frova). The proportion of sustained
pain free at 24 h was 26 % under
Frova, 43 % under FroDex25 mg and 40 % under FroDex37.5 mg (p = NS FroDex25 or 37.5 vs.
Frova) in the early
drug intake subgroup, while it was 19 % under
Frova, 43 % under FroDex25 mg and 45 % under FroDex37.5 mg (p < 0.05 FroDex25 and FroDex37.5 vs.
Frova) in the late
drug intake subgroup. Risk of relapse at 48 h was similar (p = NS) among study
drug groups (
Frova: 25 %, FroDex25: 21 %, and FroDex37.5: 37 %) for the early as well as for the late
drug use subgroup (14, 42 and 32 %). FroDex was found to be more effective than
Frova taken either early or late. The intrinsic pharmacokinetic properties of the two single
drug components made FroDex combination particularly effective within the 2-48-h window from the onset of the acute
migraine attack. The efficacy does not seem to be influenced by the time of
drug use relative to the onset of
headache.