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(Stroke. 1998;29:1067.)
© 1998 American Heart Association, Inc.

Letters to the Editor

Lubeluzole Treatment of Acute Ischemic Stroke

J. Lodder, MD, PhD

University Hospital Maastricht, Department of Neurology, Maastricht, the Netherlands

To the Editor:

The final conclusion of the recently published article¹ on lubeluzole treatment of acute ischemic stroke, that "treatment with lubeluzole within 6 hours of the onset of ischemic stroke resulted in improved clinical outcome at three months with no safety concerns," may not result from the data presented and the way they were analyzed. The primary aim of this trial was to test the null hypothesis that treatment with lubeluzole results in outcome similar in terms of death at 3 months to placebo treatment. As the primary end points "all deaths" showed no statistically significant difference between groups, the null hypothesis cannot be rejected. The fact that the number of deaths were (not statistically significant) lower in the lubeluzole group may well be due to chance because of small numbers or to differences in baseline characteristics; fewer males and fewer patients with various types of cardiac disease in the lubeluzole-treated group may have favored better outcome in the treatment group. From the analysis description, adjustments for these differences cannot be inferred. Secondly, fewer patients in the lubeluzole group died from hemorrhage, but no reason other than a possible effect of lubeluzole explaining this difference was discussed. Was there perhaps a higher number of patients with hemorrhage in the placebo group in the first place, thus favoring better outcome in the lubeluzole group? The statistically insignificant lower death rate in the lubeluzole group was due in part to the apparently lower number of deaths from congestive heart failure. However, . . . [Full Text of this Article]

James Grotta, MD

Department of Neurology, University of Texas Health Science Center, Houston, Texas