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New Research Confirms the Benefit of Extended-Release Dipyridamole,Plus ASA for Preventing Recurrent Stroke in Low- and High-Risk,Patients

Aggrenox® (Asasantin® Retard) considered by many as first-line in secondary stroke prevention

INGELHEIM, Germany, 31 May 2007 - New data presented today at the 16th European Stroke Conference in Glasgow confirm that therapy with dipyridamole plus ASA (extended-release dipyridamole plus ASA is marketed as Aggrenox® or Asasantin® Retard) is superior to ASA* alone in preventing new vascular events in patients who had a TIA or minor ischaemic stroke, irrespective of their baseline risk.1

The new meta-analysis of five clinical trials compared 3,800 patients who were treated with dipyridamole plus ASA with 3,812 patients who received ASA alone. Most of the patients received dipyridamole as an extended-release formulation. For the overall population, dipyridamole plus ASA was significantly more effective than ASA alone in preventing recurrent stroke, with a relative reduction of 22 percent (hazard ratio 0.78; 95 percent CI 0.68–0.90). The combined endpoint of vascular death, non-fatal myocardial infarction and non-fatal stroke was significantly reduced by 18 percent (hazard ratio 0.82; 95 percent CI 0.72–0.92). Dipyridamole plus ASA was equally beneficial in subgroup analyses of patients who were hypertensive or had previous ischaemic heart disease. Benefit was also seen in all baseline risk strata as assessed with two different risk scores.

Co-author of this investigation, Professor Ale Algra, University Medical Center Utrecht, Netherlands commented: "This new meta-analysis confirms that the combination of ASA and dipyridamole is more effective than ASA alone in patients with TIA or ischaemic stroke of presumed arterial origin. This means that in the secondary prevention of stroke, stroke patients can benefit from the combination treatment with dipyridamole plus ASA independent of their underlying risk."

The largest trials included in the meta-analysis we re the recent European Australasian Stroke Prevention in Reversible Ischaemia Trial (ESPRIT),2 and the second European Stroke Prevention Study (ESPS 2).3 Both of these trials reported significant reductions in the incidence of recurrent stroke in patients treated with dipyridamole plus ASA compared with ASA alone (a total of 83 percent of the patients received extended-release dipyridamole, and up to 8 percent received the fixed-dose combination twice daily, which is marketed as Aggrenox® or Asasantin®).

A smaller proportion of patients included in the meta-analysis received an immediate release formulation of dipyridamole that may provide suboptimal plasma levels in some patients. The better absorption properties of Aggrenox® were also discussed by Professor Hartmut Derendorf of the University of Florida, U.S.A. in a symposium at the European Stroke Conference, who demonstrated that the extended-release dipyridamole formulation found in Aggrenox® is better absorbed than an immediate release dipyridamole formulation.4 This optimized formulation is buffered, allowing absorption despite fluctuations in the gastric acidity. This is particularly beneficial for elderly stroke patients in whom reduced gastric acidity or gastric and duodenal ulcer therapy is widespread.5

Stroke is the third leading cause of death worldwide after heart disease and cancer.6 Patients who survive a first stroke or TIA are at high risk of suffering a second stroke and require preventive treatment to reduce this risk. 7 The world’s largest secondary stroke prevention study - PRoFESS® (Prevention Regimen For Effectively avoiding Second Strokes) – aims to demonstrate that Aggrenox® is superior in preventing secondary strokes compared with clopidogrel. The trial has enrolled 20,333 patients in 35 countries.8

The results of PRoFESS® are expected at the European Stroke Conference in Nice, France in 2008.

Notes to Editor

About Aggrenox®
Aggrenox® is an antithrombotic that combines extended-release dipyridamole and ASA. A product of Boehringer Ingelheim`s research and development, it is indicated for the prevention of recurrent stroke and TIA. Marketed as Aggrenox® and as Asasantin® Retard, it is registered in over 55 countries worldwide.

About Stroke
Stroke is an acute event, which arises from disease of the blood vessels that supply blood to the brain. A stroke or cerebrovascular accident (CVA) causes sudden damage to the brain tissue and occurs when a blood vessel that is carrying oxygen and other nutrients to the brain bursts or is clogged by a blood clot or particulate material.9 The nerve cells are deprived of oxygen and die within minutes. Consequently, bodily functions under the control of those nerve cells will fail. The effects of a stroke are often permanent because the dead brain cells cannot be replaced.

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.

*Acetylsalicylic acid (ASA) is a lso marketed as Aspirin®


Contact:
Boehringer Ingelheim GmbH
Ursula Bardon
55216 Ingelheim am Rhein
GERMANY
Phone: +49/6132/77 26 22
E-mail

References:
1 Gray LJ, et al. European Stroke Conference, Glasgow, UK, 31 May 2007
2 ESPRIT study group. Lancet 2006; 367(9523): 1665–1673
3 Diener HC, et al. J Neurol Sci 1996; 143(1-2): 1–13.
4 Derendorf, H. European Stroke Conference, Glasgow, UK, 30 May 2007
5 Derendorf H, et al. J Clin Pharmacol 2005; 45: 845–850.
6 World Health Organization. WHO Atlas of Heart Disease and Stroke 2004; http://www.who.int/cardiovascular_diseases/resources/atlas/en
7 Hardie K, et al. Stroke 2003; 34: 1842–1846
8 Diener H et al. Cerebrovasc Dis 2007; 23: 368–380
9 Heart and Stroke Facts. The American Stroke Association; http://www.americanheart.org/downloadable/heart/1056719919740HSFacts2003text.pdf


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