CAPE TOWN, South Africa, October 26 /PRNewswire/ --
    - For non-US Healthcare Media
    - PRoFESS Study Will Compare the Combination of Extended Release
Dipyridamole and Acetylsalicylic Acid (ASA) With Clopidogrel
    Patient recruitment to the world's largest secondary stroke prevention
study PRoFESS (Prevention Regimen For Effectively avoiding Second Strokes),
is now complete. Baseline data on the 20,333 patients recruited to the
study from 720 sites in 35 countries were presented today at the Joint
World Congress on Stroke in Cape Town, South Africa.[1]
    PRoFESS aims to demonstrate that extended release dipyridamole plus
ASA[x], marketed by Boehringer Ingelheim as Aggrenox(R) or
Asasantin(R)Retard , is superior in preventing secondary strokes compared
with clopidogrel. The study will also examine whether Boehringer
Ingelheim's telmisartan (Micardis(R)), an angiotensin receptor blocker
(ARB), in addition to the usual care in individuals after a stroke, will
reduce the risk of further strokes compared with placebo.
    "The baseline data of PRoFESS confirm that we have succeeded in
enrolling a representative international patient population who have had a
stroke. All patients received standard state of the art treatments for
stroke prevention," said Professor Ralph L. Sacco, Professor of Neurology
and Epidemiology at the Neurological Institute of Columbia University
College of Physicians and Surgeons, New York, USA and a member of the
PRoFESS Steering Committee. "Patients with ischemic stroke have a high risk
of recurrent stroke and death. While acetylsalicylic acid is proven and
accepted as standard therapy in these patients, recent trials demonstrate
that a combination of ASA and dipyridamole is superior to ASA. With PRoFESS
we hope to gain further insight into the benefits of Aggrenox(R) in
preventing a recurrent stroke, as well as the first direct comparison
between the efficacy of Aggrenox(R) and clopidogrel."
    Results from ESPRIT (European/Australasian Stroke Prevention in
reversible Ischaemia Trial), published in the Lancet earlier this year,
demonstrate that the combination of extended release dipyridamole plus
acetylsalicylic acid (ASA) is superior to ASA alone as an antithrombotic
prevention treatment for stroke patients[2].
    There was a statistically significant 20 percent relative risk
reduction of primary outcome events[xx] in patients treated with
dipyridamole plus ASA compared with patients treated with ASA alone. The
study results were consistent with the outcome of the earlier European
Stroke Prevention Study-2 trial (ESPS-2), which demonstrated that
Aggrenox(R)/Asasantin(R)Retard is twice as effective for the prevention of
secondary stroke as either ASA or dipyridamole alone[3].
    The use of Aggrenox(R)/Asasantin(R)Retard 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), the American College of
Chest Physicians (ACCP) as well as the recently issued joint guidelines of
the American Heart and Stroke Association (AHA/ASA).
    Treatments used to reduce the risk of recurrent stroke work by
inhibiting platelet aggregation and thrombus formation. Aggrenox(R) 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[3],[4],[5].
    Notes to Editors
    About PRoFESS
    The PRoFESS study is a multi-center, randomized, double blind trial
involving 720 sites from 35 countries. Patients 50 years or older who have
had an ischemic stroke within the last 120 days and who were neurologically
and clinically stable, were randomized to the study. The primary outcome
for the trial is the time to any recurrent stroke. Secondary outcomes
include, among others, the composite of stroke, myocardial infarction or
vascular death with or without congestive heart failure, new onset
diabetes, other designated vascular events. The comparison between ASA plus
dipyridamole and clopidogrel is one to evaluate non-inferiority followed by
superiority. Blocking the renin angiotensin system with ACE inhibitors or
ARBs indicates that they reduce stroke. PRoFESS will determine if
telmisartan shows superiority over placebo in reducing the risk of further
strokes. PRoFESS is a study sponsored by Boehringer Ingelheim. For further
information on PRoFESS, please visit http://www.profess.com.
    About Aggrenox(R)
    Aggrenox(R) 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(R) and as Asasantin(R) 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.[6] 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 Ischemic 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.[7]
    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. For more
information please visit http://www.boehringer-ingelheim.com
    Disclaimer: Press release for international use. As to the registration
status in individual countries, please check with the contact address
indicated below or liaise with the country-specific Boehringer Ingelheim
affiliate.
    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
myocardial infarction, or major bleeding complication. The dose range of
ASA in ESPRIT was between 30 and 325mg/day, on average < 75mg/day. 83% of
the patients received ER DIP, 8% the fixed dose combination ER DIP + ASA
200/25mg twice daily.
    [1] Diener HC. Prevention Regimen for Effectively Avoiding Second
Strokes (PRoFESS), Baseline Results. Presented on 26 Oct 2006 at Joint
World Congress on 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
acetylsalicylic acid in the secondary prevention of stroke. J Neurol Sci.
1996 Nov;143(1-2):1-13
    [4] Weyrich AS et al. Dipyridamole selectively inhibits inflammatory
gene expression 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

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