(Stroke. 1999;30:1983-1990.)
© 1999 American Heart Association, Inc.
Abstracts of Literature |
| Cerebral Aneurysms |
|---|
Object. Findings from previous multicenter clinical trials have suggested that tirilazad mesylate, a synthetic nonhormonal 21-aminosteroid, might be effective in preventing delayed cerebral ischemia following subarachnoid hemorrhage (SAH). This beneficial effect, however, was greater in males than females, possibly because of gender-related pharmacokinetic differences. The authors sought to assess the effects of administering a larger dose of tirilazad in women with SAH.
Methods. To test the efficacy of a higher tirilazad mesylate
dose in female patients, a prospective randomized, double-blind,
vehicle-controlled trial was conducted at 56 neurosurgical centers in
Europe, Australia, New Zealand, and South Africa. Eight hundred
nineteen patients were randomly assigned to receive either 15 mg/kg/day
of tirilazad mesylate or a placebo containing the citrate vehicle. The
two groups were similar in prognostic factors for delayed cerebral
ischemia and overall outcome. High-dose tirilazad appeared to
be well tolerated because no differences in the incidence of untoward
medical events were noted between the two groups. Medical and surgical
interventions were no different in the two treatment groups except for
hyperdynamic therapy (intentional hypervolemia, induced hypertension,
and/or hemodilution), which was more often used in the placebo-treated
group to
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