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Published on 9 February 2009

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ESO recommends extended time window for Actilyse

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Based on key results from the European Cooperative Acute Stroke Study (ECASS 3), the European Stroke Organisation (ESO) now recommends that Actilyse (alteplase) be given within 4.5 hours of onset of ischaemic stroke, although treatment beyond 3 hours from the onset of stroke currently is not included in the European labelling.

ECASS 3, a randomised, double-blind, placebo-controlled trial, showed for the first time that thrombolysis with Actilyse can increase the likelihood of achieving good outcome with only minimal or no disability after an acute ischaemic stroke when administered in an extended time-window from 3 to 4.5 hours after symptom onset.

This news comes shortly after The Lancet selected ECASS 3 as one of the top three papers of 2008, and Lancet editors singled out the study as their choice for paper of the year.

Writing in the 24 January 2009 issue of The Lancet, executive editor William Summerskill said that ECASS 3 and the other papers of the year “embody the can-do spirit of visionary research. They extend the horizon of our understanding and add to our tools for treating important common health problems that were once believed overwhelming.”

The World Health Organisation estimates that 5.7 million people in the world die each year from stroke. Among survivors, 40% experience moderate to severe disability and 10% require institutional care.

For patients with an acute ischaemic stroke the only treatment currently available is Actilyse, which has to be administered within 3 hours of symptom onset according to its currently approved label. The ECASS 3 trial was set up to investigate whether Actilyse can show a net-benefit of treatment in the 3 to 4.5 hour time window. ECASS 3 included 821 patients in 15 European countries who were recruited by a team of investigators led by Professor Werner Hacke of the University of Heidelberg. Results were published in the New England Journal of Medicine in September 2008.

Dr Manfred Haehl, corporate senior vice president medicine, Boehringer Ingelheim said: “We are proud of the success of ECASS 3 and would like to thank our lead investigator, all the investigators throughout Europe, the trial team and most notably patients and their relatives for their participation in this landmark study in acute ischaemic stroke. Boehringer Ingelheim is committed to seeking an update to the Actilyse label and will present the new clinical evidence generated by ECASS 3 to regulatory authorities as soon as possible.”

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Boehringer Ingelheim



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