Ebselen in acute middle cerebral artery occlusion: a placebo-controlled, double-blind clinical trial.
A randomized, double-blind, placebo-controlled trial of ebselen was conducted in patients with complete occlusion of the middle cerebral artery. Ebselen or placebo granules suspended in water (150 mg b.i.d. ) were orally administered within 12 h of onset and continued for 2 weeks. The major end points were the maximum volume of cerebral infarct measured on follow-up computed tomography and the Glasgow Outcome Scale score at 1 month. One hundred and five patients were enrolled in this trial. Although the intent-to-treat analysis of 99 patients (43 given ebselen and 56 given placebo) did not reach statistical significance in reduction of the infarct volume (p = 0. 099), the protocol-compatible analysis of 83 patients with complete occlusion of the middle cerebral artery (34 given ebselen and 49 given placebo) determined a significant reduction using ebselen treatment (p = 0.034). A good outcome was seen in approximately 15% more patients from the ebselen group, but the difference between the 2 groups was not significant (p = 0.129). There was a corresponding significant reduction in the volume of cerebral infarct and an improvement in the outcome of patients who started treatment within 6 h of onset. These findings may suggest that ebselen protected the brain from ischemic damage in the acute stage.
Ogawa
A
A
Iwate Medical University, Morioka, Japan.
Yoshimoto
T
T
Kikuchi
H
H
Sano
K
K
Saito
I
I
Yamaguchi
T
T
Yasuhara
H
H
D000368:Aged; D000975:Antioxidants / Q000009:adverse effects / Q000627:therapeutic use*; D001157:Arterial Occlusive Diseases / Q000188:drug therapy* / Q000401:mortality; D001393:Azoles / Q000009:adverse effects / Q000627:therapeutic use*; D002536:Cerebral Arteries / Q000187:drug effects / Q000503:physiopathology; D002544:Cerebral Infarction / Q000000981:diagnostic imaging; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D054833:Isoindoles; D008297:Male; D008875:Middle Aged; D016566:Organoselenium Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome