1. Rizatriptan in migraineurs with unilateral cranial autonomic symptoms: a double-blind trial.
- Author
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Barbanti, Piero, Fofi, Luisa, Dall'Armi, Valentina, Aurilia, Cinzia, Egeo, Gabriella, Vanacore, Nicola, and Bonassi, Stefano
- Subjects
SEROTONIN agonists ,HETEROCYCLIC compounds ,AUTONOMIC nervous system ,CHI-squared test ,CONFIDENCE intervals ,STATISTICAL correlation ,FISHER exact test ,MIGRAINE ,HEALTH outcome assessment ,REGRESSION analysis ,RESEARCH funding ,STATISTICS ,T-test (Statistics) ,DATA analysis ,TRYPTAMINE ,RANDOMIZED controlled trials ,TREATMENT effectiveness ,BLIND experiment ,SEVERITY of illness index ,DATA analysis software ,DESCRIPTIVE statistics ,SYMPTOMS ,THERAPEUTICS - 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. [ABSTRACT FROM AUTHOR]
- Published
- 2012
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