Key result
Rizatriptan decreased peripheral systolic blood pressure gradients by -5 mmHg (95% CI: -7, -3) compared to -1 mmHg (95% CI: -3, 1) for placebo in the 0-4 h interval.
Why the study?
Does rizatriptan, ergotamine, and their combination cause peripheral vasoconstriction compared to placebo in normal young male volunteers?
RCT (n=16)
Double-blind
Does rizatriptan, ergotamine, and their combination cause peripheral vasoconstriction compared to placebo in normal young male volunteers?
Absolute Event Rate: -5% vs -1%
Rizatriptan caused a greater decrease in peripheral systolic blood pressure gradients compared to placebo in the first 4 hours after dosing in normal young male volunteers.
Rizatriptan induces peripheral vasoconstriction in healthy males; extends RCT evidence to support vascular caution in migraine prescribing.
AIMS: To compare the peripheral vasoconstrictor effects of ergotamine, rizatriptan, and their combination, in normal subjects. METHODS: This was a double-blind, four-way, crossover study. Sixteen young male volunteers, selected as responders to the vasoconstrictor effect of 0.5 mg ergotamine i.v., were administered 10 mg oral rizatriptan, 0.25 mg i.v. ergotamine, 10 mg oral rizatriptan+0.25 mg i.v. ergotamine, and placebo. The vasoconstrictor effect on peripheral arteries was measured with strain gauge plethysmography up to 8 h after dosing. The 8 h assessment period was divided into two 4 h intervals to assess the immediate (0-4 h) vs sustained effect (4-8 h) of treatment. RESULTS: For the 0-4 h interval, the decreases in peripheral systolic blood pressure gradients were: placebo (-1 mmHg [95% CI: -3, 1])<rizatriptan (-5 mmHg [95% CI: -7, -3])
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Tfelt‐Hansen et al. (2002) conducted an RCT in Healthy volunteers (n=16). Rizatriptan, ergotamine, and their combination vs. Placebo was evaluated on Decreases in peripheral systolic blood pressure gradients for the 0-4 h interval. Rizatriptan decreased peripheral systolic blood pressure gradients by -5 mmHg (95% CI: -7, -3) compared to -1 mmHg (95% CI: -3, 1) for placebo in the 0-4 h interval.
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