ReoPro(R) (abciximab) significantly improves the recovery of patients with ischaemic stroke when administered up to six hours after stroke onset, according to new data from AbESTT (Abciximab in Emergent Stroke Treatment Trial) presented today at the 12th European Stroke Conference in Valencia, Spain.
Taking into account the severity of stroke when assessing recovery makes clinical sense, and these AbESTT results demonstrate a significant therapeutic benefit of ReoPro in patients with ischaemic stroke.
Davalos will report that significantly more AbESTT patients treated with ReoPro within five hours of the onset of stroke achieved mRS scores of 0 or 1 (normal or near-normal function) than placebo (53.
Previous data from AbESTT confirmed the safety of ReoPro in ischaemic stroke, and demonstrated trends suggesting ReoPro may increase recovery and reduce mortality2-3.
AbESTT was a randomised, double-blind, placebo-controlled Phase IIb trial of ReoPro in 400 adult patients with acute ischaemic stroke who were able to be treated within six hours of stroke onset.
In this study, known as AbESTT (Abciximab in Emergent Stroke Treatment Trial), doctors could administer ReoPro to stroke patients as long as six hours after the onset of stroke, potentially increasing the likelihood of improving physical outcome.
In the AbESTT trial, bleeding into the brain causing symptoms trended higher with ReoPro (3.
The AbESTT trial is exciting because it is the first trial testing an intravenously given medication to suggest a trend towards a clinical benefit for acute stroke patients up to six hours after stroke onset," said Harold Adams, MD, Professor of Neurology, University of Iowa Carver College of Medicine and lead investigator of the AbESTT trial.
The results of the AbESTT trial are particularly encouraging in that more than 95 percent of patients were treated three hours after symptoms began," said Lawrence Deckelbaum, MD, Vice President of General Medicine, Clinical Research and Development at Centocor.
The results of the AbESTT (Abciximab in Emergent Stroke Treatment Trial), a new study in patients with ischaemic stroke, were announced today at the American Stroke Association's 28th International Stroke Conference in Phoenix, Arizona.
The AbESTT results suggest that it may be possible to improve outcomes up to six hours after the onset of stroke," said Professor Werner Hacke of the Neurology clinic at Ruprecht Karls Universitat Heildeberg, Germany.
Lilly and Centocor are committed to further investigation of the use of ReoPro for ischaemic stroke, and the results of the AbESTT trial form a strong enough case for us to proceed with a Phase III trial of ReoPro in ischaemic stroke.