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Tirilazad for acute ischaemic stroke.
P M Bath1, R Iddenden, F J Bath
1Division of Stroke Medicine, University of Nottingham, City Hospital Campus, Hucknall Road, Nottingham, Nottinghamshire, UK, NG5 1PB. philip.bath@nottingham.ac.uk
The Cochrane Database of Systematic Reviews
|November 1, 2001
Summary
Tirilazad mesylate did not improve survival in acute ischemic stroke patients but increased death or disability risk. Further trials are not recommended, but data analysis may explain adverse outcomes.
Area of Science:
- Neurology
- Clinical Trials
- Pharmacology
Background:
- Tirilazad mesylate demonstrated neuroprotective effects in experimental models of ischemic stroke.
- Clinical benefit in humans with acute ischemic stroke remained to be determined.
Purpose of the Study:
- To evaluate the safety and efficacy of tirilazad mesylate in improving outcomes for patients experiencing acute ischemic stroke.
Main Methods:
- Systematic review and meta-analysis of randomized controlled trials (RCTs) of tirilazad mesylate.
- Included double-blind, placebo-controlled trials of tirilazad administered within 24 hours of stroke onset.
- Extracted data on case fatality, disability (Barthel Index, Glasgow Outcome Scale), phlebitis, and QTc intervals.
Main Results:
- Six trials involving 1757 patients were analyzed; tirilazad did not affect early or end-of-trial case fatality.
- Tirilazad significantly increased the odds of death or disability (Odds Ratio [OR] 1.23, 95% Confidence Interval [CI] 1.01–1.51).
- Increased rates of infusion site phlebitis were observed (OR 2.81, 95% CI 2.14–3.69), with worse outcomes in females and low-dose recipients.
Conclusions:
- Tirilazad mesylate did not reduce case fatality in acute ischemic stroke but increased the combined endpoint of death or disability.
- Further clinical trials of tirilazad are not warranted.
- Analysis of individual patient data may clarify the reasons for worsened outcomes.