Gavestinel does not improve outcome after acute intracerebral hemorrhage: an analysis from the GAIN International and GAIN Americas studies

Haley, E.C., Thompson, J.L.P., Levin, B., Davis, S., Lees, K.R., Pittman, J.G., Derosa, J.T., Ordronneau, P., Brown, D.L. and Sacco, R.L. (2005) Gavestinel does not improve outcome after acute intracerebral hemorrhage: an analysis from the GAIN International and GAIN Americas studies. Stroke, 36(5), pp. 1006-1010. (doi: 10.1161/01.STR.0000163053.77982.8d)

Abstract

<p><b>Background and Purpose:</b> Glycine Antagonist in Neuroprotection (GAIN) International and GAIN Americas trials were prospectively designed, randomized, placebo-controlled trials of gavestinel, a glycine-site antagonist and putative neuroprotectant drug administered within 6 hours of suspected ischemic or hemorrhagic stroke. Both trials reported that gavestinel was ineffective in ischemic stroke. This analysis reports the results in those with primary intracerebral hemorrhage.</p> <p><b>Methods:</b> The primary hypothesis was that gavestinel treatment did not alter outcome, measured at 3 months by the Barthel Index (BI), from acute intracerebral hemorrhage, based on pooled results from both trials. The BI scores were divided into 3 groups: 95 to 100 (independent), 60 to 90 (assisted independence), and 0 to 55 (dependent) or dead.</p> <p><b>Results:</b> In total, 3450 patients were randomized in GAIN International (N=1804) and GAIN Americas (N=1646). Of these, 571 were ultimately identified to have spontaneous intracerebral hematoma on baseline head computerized tomography scan. The difference in distribution of trichotomized BI scores at 3 months between gavestinel and placebo was not statistically significant (P=0.09). Serious adverse events were reported at similar rates in the 2 treatment groups.</p> <p><b>Conclusions:</b> These observations from the combined GAIN International and GAIN Americas trials suggest that gavestinel is not of substantial benefit or harm to patients with primary intracerebral hemorrhage. These findings are similar to results previously reported in patients with ischemic stroke.</p>

• Item Type: Articles
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: Lees, Professor Kennedy
• Authors: Haley, E.C., Thompson, J.L.P., Levin, B., Davis, S., Lees, K.R., Pittman, J.G., Derosa, J.T., Ordronneau, P., Brown, D.L., and Sacco, R.L.
• College/School: College of Medical Veterinary and Life Sciences > School of Cardiovascular & Metabolic Health
• Journal Name: Stroke
• Publisher: American Heart Association
• ISSN: 0039-2499
• Copyright Holders: Copyright © 2005 American Heart Association
• First Published: First published in Stroke 36(5):1006-1010
• Publisher Policy: Reproduced in accordance with the copyright policy of the publisher