Lubeluzole for Stroke Treatment
February 1, 1998
Lubeluzole for Stroke Treatment
Source: Grotta J, et al. Lubeluzole treatment of acute ischemic stroke. Stroke 1997;28:2338-2346.
Lubeluzole, a new benzothiazole compound, having shown advantageous effects in non-human models of ischemic stroke, has now been tested on a human acute ischemic stroke cohort of 721 patients. Randomly assigned patients and controls with acute ischemic strokes of less than seven hours duration received infusions with either drug (7.5 mg hour 1, followed by continuous daily infusion of 10 mg up to 5 days) or placebo. Although total mortality did not differ, lubeluzole showed significant clinical benefit compared to placebo in survivors: NIH Stroke Scale P = 0.033, Barthel Index P = 0.038, Rankin Scale P = 0.034, Clinical Global Impression P = 0.041. Statistically identified improvement for lubeluzole could be identified by the end of day one and continued for the subsequent seven weeks. Except for a greater incidence of headaches and ankle edema, adverse incidents were similar compared to controls. Reducing all observations down to the core, fewer patients given lubeluzole had a (non-significantly) reduced mortality rate, but 7% significantly improved eventual outcome to a level of independent or mildly dependent status when tested three months after onset.
COMMENTARY
This carefully conducted study identifies for the first time a remarkably safe drug that, when given intravenously and started within six hours after onset, improved important stroke outcome by about 7%. Appropriately employed tPA within 180 minutes following stroke onset probably rescues functionally more cases of moderately severe acute stroke. Nevertheless, tPA requires meticulous attention to pre-evaluation and a 180-minute time limit, thereby measurably denying treatment to a significant fraction of patients. Lubeluzole appears to be the first available substitute that provides model amelioration of stroke disability when initiated within the first six hours after stroke. fp
Diamox has been widely used to produce cerebral vasodilation in patients with stroke symptoms. Best available evidence suggests:
a. the drug has no effect on cerebral arteries.
b. the drug produces arterial dilation in ischemic areas.
c. the drug does not favorably affect blood flow in areas of brain damage.
d. the drug can produce liver disease in healthy persons.
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