Abstract
The objective and background is to confirm in a double-blind, placebo-controlled study the high triptan response rates we had previously reported in an open study in migraine patients with unilateral cranial autonomic symptoms. In this randomized, double-blind, placebo-controlled study 80 migraineurs with unilateral cranial autonomic symptoms were assigned to receive rizatriptan 10 mg wafer or placebo (ratio 1:1) and treated for a single moderate or severe migraine attack. The primary endpoints were pain freedom at 2 h and total migraine freedom at 2 h. Secondary endpoints included pain relief, no associated symptoms and sustained pain freedom or relief. Significantly more patients reported pain freedom at 2 h after taking rizatriptan (54 %) than after placebo (8 %) (therapeutic gain 46 % [28 %; 64 %]; P < 0.001). Similarly, significantly more patients reported total migraine freedom at 2 h after rizatriptan (51 %) than after placebo (8 %) (therapeutic gain 43 % [26 %; 61 %]; P < 0.001). Rizatriptan was also more effective than placebo on most secondary endpoints. We confirm in a placebo-controlled study our previous data suggesting that the presence of unilateral cranial autonomic symptoms in migraineurs predicts a positive response to triptans, probably owing to intense trigeminal peripheral afferent activation which strongly recruits peripheral neurovascular 5-HT1B/1D receptors. Acute and preventive pharmacological trials in migraine should focus also on this subset of migraine patients.
Highlights
Migraine pain depends on trigeminovascular system activation that induces vasoactive neuropeptide release from trigeminal perivascular axons leading to neurogenic inflammation that stimulates meningeal sensory fibers and transmits nociceptive information centrally, along the trigeminal axons, to the trigeminal nucleus caudalis, and from there rostrally to the thalamus and cortex [1]
The objective and background is to confirm in a double-blind, placebo-controlled study the high triptan response rates we had previously reported in an open study in migraine patients with unilateral cranial autonomic symptoms
Four patients in the rizatriptan group and 5 patients in the placebo group were excluded from the efficacy assessment because they lacked a qualifying event (Fig. 1)
Summary
Migraine pain depends on trigeminovascular system activation that induces vasoactive neuropeptide release from trigeminal perivascular axons leading to neurogenic inflammation that stimulates meningeal sensory fibers and transmits nociceptive information centrally, along the trigeminal axons, to the trigeminal nucleus caudalis, and from there rostrally to the thalamus and cortex [1]. In some migraineurs, activating the trigeminovascular system may trigger the efferent parasympathetic arm of the trigeminoautonomic reflex [2] In these migraineurs, whose prevalence ranges from 26.4 % in the general migraine population to 45.8 % in patients attending a Headache Center, the clinical hallmarks are unilateral cranial autonomic symptoms (UAs) such as conjunctival injection, lacrimation, nasal congestion/ rhinorrhea, ptosis, eyelid swelling or forehead/facial sweating, singly or combined. In an open study with sumatriptan 50 mg, we previously suggested that UAs in migraineurs may predict a positive response to triptans [5].
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