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Actilyse (alteplase) Recommended by National Institute for Health,and Clinical Excellence for Treatment of Acute Ischaemic Stroke

NICE Appraisal Committee concludes that alteplase is clinically and cost effective


INGELHEIM/Germany, 14 May 2007 – A new clinical appraisal published by the National Institute for Health and Clinical Excellence (NICE) in the UK has recommended the use of alteplase for the treatment of patients with acute ischaemic stroke, based on its clinical and cost effectiveness compared with best supportive care alone.1 Alteplase is marketed as Actilyse® by Boehringer Ingelheim.*)

According to the appraisal, published on the Institute’s website on 8 May 2007, alteplase has demonstrated efficacy for treating acute ischaemic stroke within a time-window of 3 hours post stroke based on a series of randomised controlled trials that included more than 2,800 patients. These studies showed that alteplase resulted in significantly better outcomes for patients in terms of death and dependency at three months compared with placebo (odds ratio 0.64; 95 percent CI:0.50–0.83).1

In particular, the NICE appraisal committee noted the results from the recently published Safe Implementation of Thrombolysis in Stroke – MOnitoring STudy (SITS-MOST), which assessed the safety and efficacy of alteplase in routine clinical practice. SITS-MOST recruited 6,483 patients across 14 European countries and showed that mortality rates following Actilyse® treatment were even lower in routine practice than had previously been seen in randomised controlled trials (11.3 percent vs. 17.3 percent).2 The incidence of symptomatic haemorrhages and of functional independence at three months were comparable to those seen in randomised controlled trials.1

Manfred Haehl, MD, Corporate Senior Vice-President Medicine at Boehringer Ingelheim, commented: “Boehringer Ingelheim welcomes the endorsement of Actilyse® from NICE. Actilyse® can improve the clinical outcome for patients who
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