Abstract | INTRODUCTION: AREAS COVERED: EXPERT OPINION: To date, all Phase III trials have failed to demonstrate the superiority of trafermin over placebo when given within 6 h from stroke onset because trafermin causes a dose-dependent hypotension and an increased mortality rate in treated patients. However, a 24-h intravenous infusion seems to be safe for stroke patients and may result in an improved outcome when given 5 - 6 h after infarct. This finding may open renewed interest in restorative treatment for stroke, which could enhance recovery mechanisms rather than immediate neuroprotection. Studies suggest that growth factors can produce improvement in animal models of stroke, even when administered at postischemic intervals from many hours to days, when conventional neuroprotective approaches are typically ineffective. Because of the number of side effects and increased mortality reported in the first clinical studies with high dose of FGF, further experimental studies are necessary to asses whether it is possible to achieve a pharmacologically significant therapeutic level in the brain, by minimizing peripheral side effects. Another randomized clinical trial is needed to test trafermin in stroke patients but to enhance functional recovery.
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Authors | Maurizio Paciaroni, Julien Bogousslavsky |
Journal | Expert opinion on biological therapy
(Expert Opin Biol Ther)
Vol. 11
Issue 11
Pg. 1533-41
(Nov 2011)
ISSN: 1744-7682 [Electronic] England |
PMID | 21883031
(Publication Type: Journal Article)
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Chemical References |
- Neuroprotective Agents
- Peptide Fragments
- trafermin
- Fibroblast Growth Factors
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Topics |
- Animals
- Brain Ischemia
(drug therapy, mortality)
- Evidence-Based Medicine
- Fibroblast Growth Factors
(administration & dosage, adverse effects, therapeutic use)
- Humans
- Neuroprotective Agents
(administration & dosage, adverse effects, therapeutic use)
- Peptide Fragments
(administration & dosage, adverse effects, therapeutic use)
- Randomized Controlled Trials as Topic
- Stroke
(drug therapy, mortality)
- Time Factors
- Treatment Outcome
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