Annual Report 2006 - Boehringer Ingelheim

the American College of Chest Physicians (ACCP),
as well as the recently issued joint guidelines of
the American Heart and Stroke Association (AHA/
ASA).
For more information please visit the website:
www.stroke-forum.com
Our clinical studies in stroke prevention
profess®, one of Boehringer Ingelheim’s landmark
studies, has concluded recruitment with
20,300 patients enrolled. It had been designed to
confirm the efficacy, and potentially demonstrate
the superiority, of aggrenox® over clopidogrel
prove as well as to the additional protective benefits
of our ARB micardis® in the prevention of
secondary stroke. As profess® is proceeding to
plan, we foresee final recruitment of patients and
availability of results in 2008.
The independent esprit study (European/
Australasian Stroke Prevention in Reversible
Ischaemia Trial) on prevention of secondary
stroke was published in Lancet, 2006; 367: 1665–
1673. It found superior efficacy of dipyridamole
extended release in combination with ASA versus
ASA alone. These results with a 20 % risk reduction
for stroke over ASA alone in the ESPRIT
study are in line with our own ESPS 2 results and
support our expectation in favour of a positive
outcome of profess®.
Treatment and prevention of thrombo-embolic
diseases
Our presently largest phase III programme is for
dabigatran etexilate, an oral direct thrombin
inhibitor that we are developing for the prevention
and treatment of thrombo-embolic disease.
Dabigatran is the frontrunner of all new oral anticoagulants
currently being developed, and is
being investigated in the primary prevention of
Boehringer Ingelheim A n n u A l R e p o R t 2 0 0 6
Promising new drug
for blood clot prevention
Therapeutic options for preventing thrombo-embolic diseases
remain limited, despite their being among the most common
causes of death in the aging societies of the industrialised
world.
The anticoagulant dabigatran etexilate, a new direct thrombin
inhibitor discovered and developed by Boehringer Ingelheim,
holds out the promise of a new drug to fulfil the unmet
therapeutic need.
The most commonly used oral anticoagulant has been
warfarin. Dabigatran etexilate specifically and reversibly
inhibits thrombin, one of the key enzymes for blood clot
formation. It is administered in a fixed dose and has a rapid
onset of action, providing a consistent anticoagulation
effect without the need for time-consuming coagulation
monitoring and dose adjustment.
Major indication areas will be stroke prevention in atrial
fibrillation, the most common form of cardiac arrhythmia,
prevention of deep vein thrombosis (DVT) after hip or knee
replacement surgery, acute DVT treatment and secondary
prevention of DVT.
deep vein thrombosis (DVT) after hip or total knee
replacement, the treatment of acute DVT, the
secondary prevention of DVT and the long-term
prevention of thrombo-embolic events (stroke) in
patients with atrial fibrillation. The phase III trial
programme has been initiated with a group of
studies combined under the umbrella of the
re-volution® programme. With more than
27,000 patients re-volution® is the largest
clinical trial programme in thrombo-embolic
disease.
With studies in all indications successfully imple-
mented, the two indications we advanced most
were the post-surgery prevention of DVT and
stroke prevention in atrial fibrillation. We have
launched a 15,000-patient study (rely) in atrial