Landmark Trial ONTARGET(R) Proves Telmisartan is as Protective as Ramipril and Better Tolerated in a Broad High-Risk Cardiovascular Population. From ONTARGET(R) it May be Concluded That Telmisartan ca

Ingelheim, Germany (ots/PRNewswire) -

- Results of 25,620 Patient Study ONTARGET(R) (ONgoing
Telmisartan Alone and in Combination With Ramipril Global Endpoint
Trial) Presented Today at the 57th Annual Scientific Session of the
American College of Cardiology(1)

- For Non-US Healthcare Media

The results of the landmark ONTARGET(R) Trial have proven that
telmisartan, brand name MICARDIS(R), a modern angiotensin II receptor
blocker (ARB), is as protective as the current gold standard,
ramipril, in reducing the risk of cardiovascular death, myocardial
infarction, stroke, and hospitalisation for congestive heart failure
in a broad cross-section of high-risk cardiovascular patients and
with better tolerability.(1) These cardiovascular events occurred in
16.66% of patients receiving telmisartan versus 16.46% of patients
receiving ramipril.(1) The relative risk (ratio of the probability of
the event occurring in the telmisartan group versus the ramipril
group) was 1.01, with a 95% CI of 0.94 -1.09.

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In 2000, the HOPE trial showed that the cardiovascular risk for
patients treated with ramipril is reduced by approximately 20%
compared with placebo.(2) This meant that every fifth serious
cardiovascular event in a high risk group of patients was prevented.
A similar effect can now be attributed to telmisartan. The 25,620
high-risk patients in the ONTARGET(R) trial were already receiving
standard care such as statins to lower cholesterol, antiplatelet
therapy, betablockers and other antihypertensives.(3)

Telmisartan was also shown to be significantly better tolerated
than ramipril, a widely used angiotensin converting enzyme inhibitor
(ACE), with respect to typical ACE-inhibitor side-effects.(1)
Although patients with an ACE-inhibitor intolerance had been excluded
from the trial, 360 patients in the ramipril treatment arm stopped
their treatment because they experienced cough versus only 93
patients in the telmisartan arm.

25 patients stopped their treatment in the ramipril arm because
of angioneurotic edema, versus only 10 in the telmisartan arm.(1)

The ONTARGET(R) data also show that telmisartan is associated
with a higher treatment compliance.(1) Besides efficacy, tolerability
and compliance are also important factors to consider as they are
crucial for effective long-term treatment for the prevention of
serious cardiovascular events.

Telmisartan is now the only angiotensin II receptor blocker (ARB)
to have proven cardio & vascular protective benefits beyond blood
pressure reduction in this high-risk population.(1) Until now, only
the ACE-inhibitor ramipril had shown these protective effects.(2)

ONTARGET(R) also studied the value of combining telmisartan with
ramipril, to answer a key question for the clinical community - does
combining an ACE inhibitor and an ARB, i.e. the dual
renin-angiotensin system (RAS) blockade, offer even better protection
compared to single blockade? The results announced today indicate
that there is no additional protective benefit achieved for the
overall patient population, if ramipril and telmisartan are combined.

Implications of the ONTARGET(R) Trial

"The ONTARGET(R) Trial shows that telmisartan is a well-tolerated
treatment in high-risk cardiovascular patients that is as effective
as ramipril in preventing heart attacks, stroke, hospitalisations for
heart failure and deaths", said Professor Salim Yusuf, lead
investigator of the ONTARGET(R) Trial Programme and Director of the
Population Health Research Institute at McMaster University,
Hamilton, Canada. "The ONTARGET results have important implications
for the management of patients with cardiovascular diseases. We now
have a new treatment option for high-risk patients which is effective
and better tolerated."

Largest ARB outcome trial ever

ONTARGET(R) is a randomised, double-blind clinical trial, which
evaluated 25,620 high-risk cardiovascular patients with normal or
controlled blood pressure over an observation period of up to 6
years.

"We are proud to have started ONTARGET(R), the largest outcome
cardiovascular trial ever undertaken with an ARB. It included
high-risk cardiovascular patients with a history of coronary heart
disease, stroke, transient ischaemic attack, peripheral vascular
disease or diabetes with target organ damage. The trial has an
extremely robust data base that will enable the medical community to
answer questions where no scientific proof was available before. With
99.8% of patients followed over these years, this is one of the best
managed landmark trials ever. We owe this excellent management of the
trial to the investigators in over 700 centres across 40 countries
led by Professor Salim Yusuf and his team at McMaster University,
Hamilton, Canada." said Dr Andreas Barner, Member of the Board of
Managing Directors of Boehringer Ingelheim, responsible for Research,
Development and Medicine.

Benefits related to exceptional properties and structure of
telmisartan

Further evidence of the exceptional properties of telmisartan has
already been seen in previous trials. In 2007, the AMADEO trial
showed that telmisartan achieved significantly greater reduction in
proteinuria compared with the ARB losartan beyond blood pressure
reduction effects, demonstrating the potential for renal protection
with telmisartan in diabetic patients.(4) In addition, in 2006 the
PRISMA trials in hypertensive patients demonstrated that telmisartan
achieved more powerful blood pressure reductions compared with the
ACE-inhibitor ramipril.(5,6)

"The benefits of telmisartan seen in ONTARGET(R) and previous
trials may be attributed to the specific pharmacological properties
and mode of action of telmisartan, including long half-life, large
volume of distribution, high cell penetration and a selective AT1
blockade. ONTARGET(R) now provides the evidence that the properties
of telmisartan translate into relevant clinical outcomes", commented
Professor Michael Bohm, Director of the Department of Cardiology,
Universitatsklinik des Saarlandes, Homburg, Germany and National
Coordinator of the ONTARGET(R) Trial in Germany.

Addressing the world's largest healthcare burden

Cardiovascular disease (CVD) is the leading cause of death
worldwide, causing over 17.5 million deaths per year.(7) 7.6 million
people die from a heart attack and 5.7 million die from a stroke
every year.(7) Global deaths from CVD are predicted to reach
approximately 25 million by 2020.(8) CVD is also currently a leading
cause of disability, and is predicted to be the largest cause of
disability worldwide by 2020.(8) A major stroke is viewed by more
than half of those at risk as being worse than death.(9)

Please be advised

This release is from the Corporate Headquarters of Boehringer
Ingelheim and is intended for all international markets. This being
the case, please be aware that there may be some differences between
countries regarding specific medical information including licensed
uses. Please take account of this when referring to the material, and
always check the statement you may plan against the jurisdiction in
your country, because this may differ from country to country.

Related links:

http://www.news-ontarget.com

http://www.ontarget-telmisartan.com

http://www.micardis.com

To view the Notes to Editors and References for this release
please go to the Notes to Editors section on:
http://www.prnewswire.com/mnr/boehringeringelheim/32495

ots Originaltext: Boehringer Ingelheim
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Contact: Corporate Division Communications, Boehringer Ingelheim
GmbH, 55216 Ingelheim/Germany, Phone: +49-6132-77-97296, 77-8271,
Fax: +49-6132-72-6601, E-mail: press@boehringer-ingelheim.com


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