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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 have suffered an acute ischaemic stroke. This is important since acute ischaemic stroke is responsible for considerable disability and mortality worldwide and we hope that this recommendation from NICE will allow more patients with qualifying stroke in the UK to benefit from treatment with Actilyse®.”

In reaching their decision, NICE also found that the use of alteplase with best supportive care is cost effective when compared with placebo and best supportive care.1 The Nice appraisal recommends that alteplase should be used by physicians trained and experienced in the management of acute stroke and only in centres with facilities that enable it to be used in full accordance with its marketing authorisation.

While the NICE appraisal emphasises the importance of using alteplase only within 3 hours after the onset of stroke symptoms, the European Cooperative Acute Stroke Study (ECASS) III,3 in accordance with the marketing authorisation evaluates the potential efficacy and safety of using Actilyse® within a time-window of 3 to 4.5 hours in patients with acute ischaemic stroke. Results of the ongoing ECASS III trial are expected in 2008.

Notes to Editor

About Actilyse®
Stroke is a neurological emergency that can affect a specific area, or sometimes all of the brain. It can be caused by a burst blood vessel (haemorrhagic stroke) or occur when a vessel is obstructed by a blood clot (ischaemic stroke). Actilyse® (alteplase) is the first and only treatment available for acute ischaemic stroke recommended by international guidelines as a first-line treatment.4,5,6 Actilyse® is a clot-busting drug, which is injected directly into a vein. In line with the Actilyse® label, patients need to receive the medication within three hours of the onset of their stroke symptoms. Randomised placebo-controlled studies have shown that thrombolysis with Actilyse®, administered within three hours of the onset of symptoms of ischaemic stroke, significantly improves clinical outcome at three months. Alteplase is an enzyme that occurs naturally in humans and causes blood clots to dissolve.

*) Actilyse® (alteplase) is registered in 85 countries across the world and marketed outside North America and Japan by Boehringer Ingelheim.

About SITS-MOST (Safe Implementation of Thrombolysis in Stroke - MOnitoring STudy)
Systematic reviews of randomised controlled trials indicate that treatment with thrombolytics is highly beneficial when given within three hours from onset of stroke symptoms. SITS-MOST, the world’s largest stroke registry/network for acute stroke centres, has demonstrated that broad implementation of thrombolysis in acute stroke treatment is both as safe and as effective in routine clinical practice as it has been shown to be in randomised clinical trials. Data from SITS-MOST (n=6483) show that ‘real-life’ treatment with Actilyse® within three hours resulted in both improved mortality (11.3% vs. 17.3%) and safety (symptomatic intracerebral haemorrhage 7.3% vs. 8.6%) when compared to randomised controlled trials.2

SITS-MOST is embedded within the Safe Implementation of Thrombolysis in Stroke International Stroke Thrombolysis Register (SITS-ISTR), an internet-based, international monitoring registry for auditing the safety and efficacy of routine therapeutic use of thrombolysis in acute ischaemic stroke. The registry is available to clinicians in many countries worldwide except Japan and North America. Acute stroke treatment with thrombolysis is currently under-used with wide variations from country to country and region to region. Less than two percent of overall stroke patients in the EU currently receive thrombolysis.

The objective of the ECASS III study is to evaluate the efficacy and safety of intravenous thrombolysis using Actilyse® in patients with acute ischaemic stroke and confirm that the thrombolytic therapy with Actilyse® within a time-window of 3 to 4.5 hours after ischaemic stroke onset improves outcome compared to a placebo-treated control group.3 The study started in July 2003 and recruitment is ongoing. It is planned to include 800 patients into this trial in 15 European countries.

About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 137 affiliates in 47 countries and 38,400 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.

In 2006, Boehringer Ingelheim posted net sales of 10.6 billion euro while spending one fifth of net sales in its largest business segment Prescription Medicines on research and development.

Please be advised
This release is from the Corporate Headquarters of Boehringer Ingelheim and is intended for all international markets. This being the case, please be aware that there may be some differences between countries regarding specific medical information including licensed uses. Please take account of this when referring to the material.

Related links:
SITS International (Safe Implementation of Thrombolysis in Stroke)

Boehringer Ingelheim GmbH
Ursula Bardon
55216 Ingelheim am Rhein
Phone: +49/6132/77 26 22

1 National Institute for Health and Clinical Excellence. Final appraisal determination: alteplase for the treatment of acute ischaemic stroke.
2 Wahlgren N, Ahmed N, Davalos A, et al. Thrombolysis with alteplase for acute ischaemic stroke in the Safe Implementation of Thrombolysis in Stroke-Monitoring Study (SITS-MOST): an observational study. Lancet 2007; 369: 275–82
3 ECASS 3 - The European Cooperative Acute Stroke Study
4 Stockholm: Karolinska Stroke Update Meeting, 2000. Consensus Statement on Thrombolysis: Available from:
5 Adams HP Jr, Adams RJ, Brott T, et al. Guidelines for the early management of patients with ischaemic stroke: a scientific statement from the Stroke Council of the American Stroke Association. Stroke 2003; 34: 1056–83
6 The European Stroke Initiative Executive Committee and European Stroke Initiative Writing Group: European stroke initiative recommendations for stroke management – update 2003. Cerebrovasc Dis 2003; 16: 311–37


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