CAPE TOWN, South Africa, October 26 /PRNewswire/ --
- For non-US Healthcare Media
- PRoFESS Study Will Compare the Combination of Extended ReleaseDipyridamole and Acetylsalicylic Acid (ASA) With Clopidogrel
Patient recruitment to the world's largest secondary stroke preventionstudy PRoFESS (Prevention Regimen For Effectively avoiding Second Strokes),is now complete. Baseline data on the 20,333 patients recruited to the studyfrom 720 sites in 35 countries were presented today at the Joint WorldCongress on Stroke in Cape Town, South Africa.[1]
PRoFESS aims to demonstrate that extended release dipyridamole plusASA[x], marketed by Boehringer Ingelheim as Aggrenox(R) or Asasantin(R)Retard, is superior in preventing secondary strokes compared with clopidogrel. Thestudy will also examine whether Boehringer Ingelheim's telmisartan(Micardis(R)), an angiotensin receptor blocker (ARB), in addition to theusual care in individuals after a stroke, will reduce the risk of furtherstrokes compared with placebo.
"The baseline data of PRoFESS confirm that we have succeeded in enrollinga representative international patient population who have had a stroke. Allpatients received standard state of the art treatments for strokeprevention," said Professor Ralph L. Sacco, Professor of Neurology andEpidemiology at the Neurological Institute of Columbia University College ofPhysicians and Surgeons, New York, USA and a member of the PRoFESS SteeringCommittee. "Patients with ischemic stroke have a high risk of recurrentstroke and death. While acetylsalicylic acid is proven and accepted asstandard therapy in these patients, recent trials demonstrate that acombination of ASA and dipyridamole is superior to ASA. With PRoFESS we hopeto gain further insight into the benefits of Aggrenox(R) in preventing arecurrent stroke, as well as the first direct comparison between the efficacyof Aggrenox(R) and clopidogrel."
Results from ESPRIT (European/Australasian Stroke Prevention inreversible Ischaemia Trial), published in the Lancet earlier this year,demonstrate that the combination of extended release dipyridamole plusacetylsalicylic acid (ASA) is superior to ASA alone as an antithromboticprevention treatment for stroke patients[2].
There was a statistically significant 20 percent relative risk reductionof primary outcome events[xx] in patients treated with dipyridamole plus ASAcompared with patients treated with ASA alone. The study results wereconsistent with the outcome of the earlier European Stroke Prevention Study-2trial (ESPS-2), which demonstrated that Aggrenox(R)/Asasantin(R)Retard istwice as effective for the prevention of secondary stroke as either ASA ordipyridamole alone[3].
The use of Aggrenox(R)/Asasantin(R)Retard as a first-line treatment forsecondary stroke prevention is recommended in many international guidelinessuch as those issued by the European Stroke Initiative (EUSI), the NationalInstitute of Health and Clinical Excellence (NICE), the American College ofChest Physicians (ACCP) as well as the recently issued joint guidelines ofthe American Heart and Stroke Association (AHA/ASA).
Treatments used to reduce the risk of recurrent stroke work by inhibitingplatelet aggregation and thrombus formation. Aggrenox(R) may possess multiplemechanisms of actions and additional pharmacological properties that mayconfer protective antithrombotic activity at the vessel wall with additionalbenefits for reducing the risk of recurrent stroke[3],[4],[5].
Notes to Editors
About PRoFESS
The PRoFESS study is a multi-center, randomized, double blind trialinvolving 720 sites from 35 countries. Patients 50 years or older who havehad an ischemic stroke within the last 120 days and who were neurologicallyand clinically stable, were randomized to the study. The primary outcome forthe trial is the time to any recurrent stroke. Secondary outcomes include,among others, the composite of stroke, myocardial infarction or vasculardeath with or without congestive heart failure, new onset diabetes, otherdesignated vascular events. The comparison between ASA plus dipyridamole andclopidogrel is one to evaluate non-inferiority followed by superiority.Blocking the renin angiotensin system with ACE inhibitors or ARBs indicatesthat they reduce stroke. PRoFESS will determine if telmisartan showssuperiority over placebo in reducing the risk of further strokes. PRoFESS isa study sponsored by Boehringer Ingelheim. For further information onPRoFESS, please visit www.profess.com.
About Aggrenox(R)
Aggrenox(R) is an antithrombotic that combines extended releasedipyridamole and ASA. A product of Boehringer Ingelheim's research anddevelopment, it is indicated for the prevention of recurrent stroke and TIA.Marketed as Aggrenox(R) and as Asasantin(R) Retard it is available in morethan 30 countries.
About Stroke
Stroke is an acute event, which arises from disease of the blood vesselsthat supply blood to the brain. A stroke or cerebrovascular accident (CVA)causes sudden damage to the brain tissue and occurs when a blood vessel thatis carrying oxygen and other nutrients to the brain bursts or is clogged by ablood clot or particulate material.[6] The nerve cells are deprived of oxygenand die within minutes. Consequently, bodily functions under the control ofthose nerve cells will fail. The effects of a stroke are often permanentbecause the dead brain cells cannot be replaced.
About Transient Ischemic Attack (TIA)
TIA is often called a 'mini stroke' with symptoms very similar to a fullstroke including sudden weakness, numbness, clumsiness or pins and needles onone 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 quarterof people suffering a TIA will go on to have a full-blown stroke within a fewyears.[7]
About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world's 20 leadingpharmaceutical companies. Headquartered in Ingelheim, Germany, it operatesglobally with 143 affiliates in 47 countries and almost 37,500 employees.Since it was founded in 1885, the family-owned company has been committed toresearching, developing, manufacturing and marketing novel products of hightherapeutic value for human and veterinary medicine.
In 2005, Boehringer Ingelheim posted net sales of 9.5 billion euro whilespending almost one fifth of net sales in its largest business segmentPrescription Medicines on research and development. For more informationplease visit www.boehringer-ingelheim.com
Disclaimer: Press release for international use. As to the registrationstatus in individual countries, please check with the contact addressindicated below or liaise with the country-specific Boehringer Ingelheimaffiliate.
Contact: Boehringer Ingelheim GmbH Ursula Bardon 55216 Ingelheim, Germany T: +49-6132-77-2622 F: +49-6132-72-2622 ursula.bardon@ing.boehringer-ingelheim.com
References
[x] Acetylsalicylic acid (ASA) is also marketed as Aspirin(R)
[xx] Nonfatal stroke, death from all vascular causes, nonfatal myocardialinfarction, or major bleeding complication. The dose range of ASA in ESPRITwas between 30 and 325mg/day, on average < 75mg/day. 83% of the patientsreceived ER DIP, 8% the fixed dose combination ER DIP + ASA 200/25mg twicedaily.
[1] Diener HC. Prevention Regimen for Effectively Avoiding Second Strokes(PRoFESS), Baseline Results. Presented on 26 Oct 2006 at Joint World Congresson Stroke
[2] Algra A et al. ESPRIT Study Group. Lancet 2006;367(9523):1665-73
[3] Diener HC, Cuhna L, Forbes C, Sivenius J, Smets P, Lowenthal A.European Stroke Prevention Study 2 (ESPS-2). Dipyridamole and acetylsalicylicacid in the secondary prevention of stroke. J Neurol Sci. 1996Nov;143(1-2):1-13
[4] Weyrich AS et al. Dipyridamole selectively inhibits inflammatory geneexpression in platelet-monocyte aggregates. Circulation 2005;111(5), 633-642
[5] Eisert WG. Dipyridamole. In Michelson A, editor. Platelets. London:Academic Press; 2002. P803-815
[6] Heart and Stroke Facts. The American Stroke Association
[7] Transient Ischaemic Attack Backgrounder. The Stroke Association UK
Boehringer Ingelheim
Contact: Boehringer Ingelheim GmbH, Ursula Bardon, 55216 Ingelheim, Germany, T: +49-6132-77-2622, F: +49-6132-72-2622, ursula.bardon@ing.boehringer-ingelheim.com
