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| Results from the ESPRIT trial published in The Lancet confirm that the combination of dipyridamole and acetylsalicylic acid (ASA) is superior to ASA alone in the prevention of recurrent stroke |
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19 May 2006
Brussels/Belgium, 19 May 2006 - Results from ESPRIT (European/Australasian Stroke Prevention in Reversible Ischaemia Trial), published in The Lancet today, confirm that extended-release dipyridamole plus acetylsalicylic acid (ASA), marketed as Aggrenox® or Asasantin® Retard, is superior to acetyl salicylic acid (ASA) as an antithrombotic prevention treatment for stroke patients.1 The study showed a statistically significant 20% relative risk reduction of primary outcome events (nonfatal stroke, death from all vascular causes, nonfatal myocardial infarction, or major bleeding complication) in patients treated with extended-release dipyridamole plus ASA compared with patients treated with ASA alone.
“Patients who have had a minor stroke or transient ischaemic attack (TIA) have an increased risk of suffering a second, and often severe or fatal, event. Thirty percent of TIA patients suffer an ischaemic stroke within five years. Aspirin (ASA) reduces this risk but until now only one large clinical trial has shown that extended-release dipyridamole added to aspirin provides even greater protection,” said Professor Philip Bath, Professor of Stroke Medicine at the University of Nottingham, UK, and an investigator in the ESPRIT study. The ESPRIT results, combined with the outcome of previous trials, provide sufficient evidence to advocate the combination of aspirin and dipyridamole as the antithrombotic therapy of choice after ischaemic stroke or TIA.”ESPRIT, an independent investigator initiated prospective, multicentre, randomised, open-label, blinded endpoint study, was conducted in 79 centres in 15 countries and randomised a total of 2,739 patients with transient ischaemic attack (TIA) or minor ischaemic stroke of presumed arterial origin. Patients were randomised to ASA (30 mg to 325 mg daily) or extended-release dipyridamole (200 mg twice daily) plus ASA (30 mg to 325 mg daily). The primary outcome event was the composite of death from all vascular causes, nonfatal stroke, nonfatal myocardial infarction or major bleeding complication, whichever happened first.
Seventeen percent of patients receiving the extended-release dipyridamole plus ASA combination discontinued the medication because of side effects, mainly headache, compared with 2% in the group treated with ASA alone. Dipyridamole induced headache typically occurs during treatment initiation and is in most cases transient. A dose-titrating scheme at initiation is commonly used to deal with this side effect.
The ESPRIT results reinforce the place of Aggrenox® in current guidelines. Its use as a first-line treatment for secondary stroke prevention is recommended in many international guidelines such as those issued by the European Stroke Initiative (EUSI), the National Institute of Health and Clinical Excellence (NICE) and the American College of Chest Physicians (ACCP).The study results are consistent with the outcome of the earlier European Stroke Prevention Study-2 trial (ESPS-2), which demonstrated that Aggrenox® is twice as effective for the prevention of secondary stroke as either ASA or dipyridamole alone.2
Treatments used to reduce the risk of recurrent stroke work by inhibiting platelet aggregation and thrombus formation. Aggrenox® may possess multiple mechanisms of actions and additional pharmacological properties that may confer protective antithrombotic activity at the vessel wall with additional benefits for reducing the risk of recurrent stroke.2,3,4
Results of the PRoFESS® (Prevention Regimen For Effectively avoiding Second Strokes) study, the largest secondary stroke prevention trial are expected in 2008. 20,000 patients from 35 countries will have participated in the trial, which aims to demonstrate that extended release dipyridamole plus ASA is superior in preventing secondary strokes compared with clopidogrel. The recruitment of this study is expected to be finalised by end of this month.
About ESPRIT
The European/Australasian Stroke Prevention in Reversible Ischaemia Trial (ESPRIT) was an investigator-led study designed to end the uncertainty about the most effective antithrombotic treatment after TIA or minor stroke of presumed arterial origin. Patients were randomised to three treatment arms: ASA, ASA plus dypiridamole and oral anticoagulation therapy within 6 months of a Transient Ischaemic Attack (TIA) or minor stroke of presumed arterial origin. The extended-release dipyridamole plus acetylsalicylic acid versus acetylsalicylic acid comparison is the subject of The Lancet publication. All patients were asked to return every 6 months for a consultation with their randomising physician or a trained trial nurse. Patients were followed up for a period of up to 5 years (mean length of follow-up was 3.5 years) with checks every 6 months. Baseline characteristics and prescribed dose of acetylsalicylic acid were similar in both treatment groups. None of the sponsors had a commercial interest in the outcome of the study.
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 available in more than 30 countries.
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.5 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 Transient Ischaemic Attack (TIA)
TIA is often called a ‘mini stroke’ with symptoms very similar to a full stroke including sudden weakness, numbness, clumsiness or pins and needles on one side of the body; sudden loss of, or blurred sight in one or both eyes; and slurred speech or difficulty finding words. Without treatment a quarter of people suffering a TIA will go on to have a full-blown stroke within a few years.6
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 143 affiliates in 47 countries and almost 37,500 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 2005, Boehringer Ingelheim posted net sales of 9.5 billion Euro while spending almost one fifth of net sales in its largest business segment Prescription Medicines on research and development.
1. The ESPRIT Study Group. Aspirin plus dipyridamole versus aspirin alone after
cerebral ischaemia of arterial origin (ESPRIT). Lancet 2006; 367: 1665-1673.
2. Diener HC. Cuhna L., Forbes C., Sivenius J., Smets P., Lowenthal A. European
Stroke Prevention Study 2 (ESPS-2). Dipyridamole and acetylsalicylic acid in
the secondary prevention of stroke. J Neurol Sci 1996; 143 (1-2): 1-13.
3. Weyrich et al. Dipyridamole selectively inhibits inflammatory gene expression in
platelet-monocyte aggregates. Circulation 2005; 111 (5): 633-642.
4. Eisert, WG. Dipyridamole. In Michelson A, editor. Platelets. London: Academic
Press; 2002. 803-815.
5. Heart and Stroke Facts. The American Stroke Association.
6. Transient Ischaemic Attack Backgrounder. The Stroke Association UK
CONTACT
Boehringer Ingelheim GmbH
Ute E. Schmidt
55216 Ingelheim
Germany
Phone: +49 (0)6132 7797296
Fax: +49 (0)6132 776601
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