Effects of fasudil in acute ischemic stroke: Results of a prospective placebo-controlled double-blind trial
| Autor: | Shin Ichi Satoh, Masato Shibuya, Eiichi Ohtomo, Shunsaku Hirai, Minoru Seto |
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| Rok vydání: | 2005 |
| Předmět: |
Male
medicine.medical_specialty Vasodilator Agents Protein Serine-Threonine Kinases Placebo Brain Ischemia law.invention Double-Blind Method Randomized controlled trial law 1-(5-Isoquinolinesulfonyl)-2-Methylpiperazine Humans Medicine Prospective Studies Adverse effect Prospective cohort study Stroke Aged Neurologic Examination rho-Associated Kinases Dose-Response Relationship Drug business.industry Cerebral infarction Intracellular Signaling Peptides and Proteins Fasudil Middle Aged medicine.disease Surgery Clinical trial Neurology Anesthesia Acute Disease Female Neurology (clinical) Intracranial Thrombosis business |
| Zdroj: | Journal of the Neurological Sciences. 238:31-39 |
| ISSN: | 0022-510X |
| DOI: | 10.1016/j.jns.2005.06.003 |
| Popis: | Background: A multicenter, double-blind, placebo-controlled study was conducted to assess the efficacy and safety of fasudil, a Rhokinase inhibitor (RKI), in the treatment of acute ischemic stroke. Methods: A total of 160 patients, who were able to receive drug treatment within 48 h of acute ischemic stroke onset were enrolled. Patients received either 60 mg fasudil or a placebo (saline) by intravenous injection over 60 min, twice daily for 14 days. The primary end points were neurological status at 2 weeks after the start of treatment, and clinical outcome at 1 month after the onset of symptoms. Results: Fasudil treatment resulted in significantly greater improvements in both neurological functions (p=0.0013), and clinical outcome (p=0.0015). There were no serious adverse events reported in the fasudil group. The average trough value (12 h values) of active metabolite hydroxyfasudil, another RKI, in healthy elderly volunteers receiving 60 mg of fasudil was 0.077 AM—a concentration well above that needed to inhibit Rho-kinase (0.025–0.05 AM). Conclusion: Treatment with fasudil within 48 h of acute ischemic stroke onset significantly improved the patient’s clinical outcome. This study found fasudil to be a useful and safe drug for patients with acute ischemic stroke. Further evaluations, for example, 3month functional outcomes in a larger clinical trial, may help to define the efficacy of fasudil in acute ischemic stroke. D 2005 Elsevier B.V. All rights reserved. |
| Databáze: | OpenAIRE |
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