Rizatriptan in migraineurs with unilateral cranial autonomic symptoms: a double-blind trial

The Journal of Headache and Pain

Clinical Trials

Gabriella Egeo¹  Luisa Fofi¹  Cinzia Aurilia¹  Piero Barbanti¹  Nicola Vanacore²  Valentina Dall’Armi³  Stefano Bonassi³ 

[1] Headache and Pain Unit, Department of Neurological, Motor and Sensorial Sciences, IRCCS San Raffaele Pisana, Via della Pisana 235, 00163, Rome, Italy;National Center of Epidemiology, National Institute of Health, Rome, Italy;Unit of Clinical and Molecular Epidemiology, IRCCS San Raffaele Pisana, Via della Pisana 235, 00163, Rome, Italy;

关键词: Migraine;    Cranial autonomic symptoms;    Trigemino-autonomic reflex;    Treatment;    Rizatriptan;   

DOI  :  10.1007/s10194-012-0440-y

 received in 2012-02-03, accepted in 2012-03-12,  发布年份 2012

来源: Springer

【 摘 要 】

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.

【 授权许可】

CC BY   
© The Author(s) 2012