Product News - November 01
Largest-ever stroke prevention trial launched
PR Newswire, London, 14/2./03 This press release is distributed on behalf of Boehringer Ingelheim.
Phoenix, Arizona - Today, in Phoenix, USA, Boehringer Ingelheim announced PRoFESS, the world's largest-ever study in second stroke prevention. PRoFESS (Prevention Regimen For Effectively avoiding Second Strokes) is designed to investigate the potential of AGGRENOX(r)/ ASASANTIN(r)Retard (dipyridamole extended release + aspirin) and MICARDIS(r) (telmisartan) to prevent second strokes.
This worldwide multicenter trial will include 16,000 patients in 21 countries. PRoFESS aims to demonstrate that AGGRENOX(r)/ASASANTIN(r) Retard is superior in preventing second strokes compared with the combination regimen of clopidogrel + aspirin. Furthermore, MICARDIS(r) is evaluated for effects on stroke risk reduction in hypertensive and non-hypertensive patients. Patient enrolment will start in September 2003 and final results are expected in 2007.
The main risk for a second stroke is a prior stroke due to degenerative processes in the wall of blood vessels supplying the brain. Patients at high risk of a second stroke with all its consequences readily seek preventive treatment. The vascular pathobiology of ischaemic stroke is multiple and antithrombotic mechanisms in the cerebro-vascular microenvironment beyond platelet inhibition are now being discussed as potentially disease-modifying and a means of reducing ischaemic stroke.
AGGRENOX(r) was chosen for the clinical trial because of the excellent results of earlier studies. The European Stroke Prevention Study-2 ESPS 2 trial has shown a relative risk reduction of 37% attributable to AGGRENOX(r) over Placebo and 23% over aspirin alone. In ESPS-2, the largest recurrent stroke prevention trial conducted previously, AGGRENOX(r) was twice as effective for secondary stroke prevention as either aspirin or dipyridamole alone, suggesting superior antithrombotic effect for combination therapy.
A meta-analysis of nearly 340.000 patients, presented at the AHA Annual Meeting 2002 has shown the lowest bleeding risk of AGGRENOX(r) compared to conventional antiplatelet therapy.
MICARDIS(r) (telmisartan) was chosen as a long acting Angiotensin II Receptor Blocker (ARB), able to completely block AII. Angiotensin II itself appears to be an independent risk factor for stroke. The study would investigate the capacity of MICARDIS(r) to further reduce the risk of recurrent stroke on top of standard treatments in both hypertensive and non hypertensice patients. MICARDIS(r) is currently being investigated in the world's largest cardiovascular protection trial programme ONTARGET. ONTARGET is a long-term multi-centre study that directly compares an ACE inhibitor (ramipril), an ARB (telmisartan/ Boehringer Ingelheim's MICARDIS(r)), and their combination treatment for the protection of patients from cardiovascular disease and death.
"With complete blockade of Angiotensin II with Micardis(r) and the anti-thrombotic actions of Aggrenox(r) , Boehringer Ingelheim has two key opportunities to prevent second strokes. The benefit for the patient is obvious: These two products which are already commercially available, may together offer the stroke patient significant additional protection. PRoFESS will help us to understand this" said Dr. Barner, Member of the Board of Managing Directors.
The PRoFESS trial is a randomised controlled double-blind factorial designed study in patients with a known prior ischaemic stroke. Patients will receive at random either AGGRENOX(r) or clopidogrel +aspirin and each of those two groups will also receive at random either MICARDIS(r) or placebo.
Dipyridamole is a product of Boehringer Ingelheim's research and development and is marketed in new formulation as AGGRENOX(r) and ASASANTIN(r) RETARD.
The Angiotensin-II-Receptor Blocker telmisartan is also a product of Boehringer Ingelheim's research and development and is marketed as MICARDIS(r) and MICARDIS(r)Plus in more than 60 countries worldwide.
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