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First Landmark ARB Trial Against Placebo Shows MICARDIS(R) (Telmisartan) Reduces the Risk of Cardiovascular Death, Heart Attack and Stroke in ACE-Intolerant High-Risk Patients(1)

Munich, Germany (ots/PRNewswire)

- TRANSCEND(R), Parallel Trial to ONTARGET(R), Confirms Long-Term
Protective Benefits and Excellent Tolerability Profile of Telmisartan
80mg(1) on Top of Current Best Standard of Care
MUNICH, Germany, August 31 /PRNewswire/ --
- For non-US Healthcare Media
The results of the TRANSCEND(R)* trial demonstrate that
MICARDIS(R) 80mg (telmisartan) reduces the risk of cardiovascular
death, myocardial infarction/heart attack and stroke in high-risk
cardiovascular patients by 13% compared with those patients already
receiving best standard of care (p=0.048), referring to the same
endpoint as that defined as the primary endpoint of the landmark HOPE
trial published in 2000.(1,2) Therapy with telmisartan was well
tolerated and showed a trend towards a lower rate of
discontinuation.(1)
To view the Multimedia News Release, please click:
http://www.prnewswire.com/mnr/boehringeringelheim/34677/
The new data on 5,926 patients from 40 countries were presented
today at the annual congress of the European Society of Cardiology
(ESC) in Munich, Germany. TRANSCEND(R)* is the first landmark trial
to test and prove the cardiovascular protective effects of an
angiotensin II receptor blocker (ARB) - Boehringer Ingelheim's
telmisartan - versus placebo, on top of standard therapy (including
anti-hypertensives, anti-platelet therapy and statins), in high-risk
individuals who cannot tolerate an angiotensin converting enzyme
(ACE)-inhibitor.
An 8% reduction of events in the pre-specified primary endpoint
made up of the composite of cardiovascular death, myocardial
infarction, stroke and hospitalization for congestive heart failure
was seen in the trial, which was statistically non-significant with a
p-value of 0.216 (HR 0.92).(1)  Translated into absolute figures,
only 465 patients in the telmisartan arm  experienced a
cardiovascular event versus 504 patients receiving placebo on  top of
current best standard of care.
All cardiovascular hospitalisations were significantly reduced
with telmisartan (894 vs 980; p=0.025). In general, the data show
that the protective effects of telmisartan were more pronounced the
longer patients were on treatment.(1)
"Earlier this year, the ONTARGET(R) Trial showed that telmisartan
is as protective as, but better tolerated than the ACE-inhibitor
ramipril.
The TRANSCEND(R) results represent a moderate but important step
forward for high-risk patients who cannot tolerate an ACE-inhibitor,"
commented Professor Salim Yusuf, lead investigator of the ONTARGET(R)
Trial Programme and Director of the Population Health Research
Institute at McMaster University, Hamilton, Canada.
Commenting on the implications of the results for general
practitioners, Dr. Sarah Jarvis, Richford Gate Medical Practice,
London, said "Until now, physicians treating ACEI-intolerant patients
at risk of heart attack or stroke did not have a proven alternative
to the ACE-inhibitor ramipril - a situation we faced with one in five
high risk patients. We now have the scientific evidence to show that
telmisartan protects  ACEI-intolerant patients against heart attack,
stroke and cardiovascular death while showing a placebo-like
tolerability. This builds on previous findings of the ONTARGET(R)
trial and gives physicians the confidence of prescribing a drug with
proven efficacy that will be taken as prescribed and not left in the
drawer."
TRANSCEND(R) included a broad cross-section of cardiovascular
high risk patients (patients older than 55 years, who have had
myocardial infarction, peripheral arterial occlusive disease, stroke
or transient ischaemic attacks or suffer from diabetes mellitus and
additional risk factors).
The trial, a parallel study to the ONTARGET(R) trial(3), which
together form The ONTARGET(R) Trial Programme, investigated the
effects of telmisartan 80mg in 5,926 patients intolerant to
widely-prescribed ACE-inhibitors. Worldwide, 10-39% of patients with
hypertension are intolerant to ACE-inhibitors(4-6) which often leads
to discontinuation of treatment leaving patients unprotected. Side
effects associated with ACE-inhibitors include intolerable cough and
rare, but potentially life threatening,  angioedema.(4-6)
Also of note, the risk reduction of 13% with telmisartan was
achieved despite a high proportion of patients receiving proven
therapies such as statins, antiplatelet agents or betablockers.
"While cardiovascular treatment has improved substantially over
the last ten years, telmisartan still further reduced cardiovascular
risk. We are proud to have advanced medical knowledge in the
cardiovascular arena with our landmark studies ONTARGET(R) and the
parallel trial TRANSCEND(R). We have followed almost 50,000
telmisartan patients in clinical trials in the last 5 years, and now
have experience from daily use of telmisartan summing up to 25
million patient years all over the world. This makes the medication
one of the best-researched cardiovascular drugs with an outstanding
efficacy and safety/tolerability profile," commented Dr Andreas
Barner, vice-chairman of the Board of Managing Directors of
Boehringer Ingelheim, responsible for Research, Development and
Medicine.
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)
Notes to editors
Please be advised
This release is from Boehringer Ingelheim Corporate Headquarters
in Germany. Please be aware that there may be national differences
between countries regarding specific medical information, including
licensed uses. Please take account of this when referring to the
information provided in this document. This press release is not
intended for distribution within the U.S.A.
About telmisartan (Micardis(R)/Kinzal(R)/Pritor(R))
Telmisartan is a modern member of the Angiotensin II Receptor
Blocker (ARB) class and is being investigated in the most ambitious
and far-reaching research programme conducted with an ARB. In the
clinical trial programmes ONTARGET(R), PROTECTION(R) and PRoFESS(R),
over 58,000 patients have been enrolled to investigate the
cardiovascular protective effects of telmisartan (for more
information please visit http://www.news-landmarktrials.com).
Telmisartan was discovered and developed by Boehringer Ingelheim.
Under the trademarks MICARDIS(R) and MICARDISPLUS(R) (combination
with hydrochlorothiazide) the company markets telmisartan in 84
countries around the world, including the USA, Japan and European
countries. Telmisartan is marketed in cooperation with Astellas
Pharma Inc. in Japan, Bayer HealthCare in Europe and GlaxoSmithKline
in selected markets.
Astellas Pharma Inc. co-promotes telmisartan under the trademark
MICARDIS(R), Bayer HealthCare promotes telmisartan under the brand
names Kinzalmono(R), Kinzalkomb(R) (combination with
hydrochlorothiazide), and Pritor(R) and PritorPlus(R) (combination
with hydrochlorothiazide) in markets across Europe. Pritor(R) and
PritorPlus(R) is also marketed by GlaxoSmithKline in selected
markets.
The sponsor of the ONTARGET(R) Trial Programme is Boehringer
Ingelheim; co-funders in selected countries are Bayer HealthCare and
GlaxoSmithKline.
Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world's 20 leading
pharmaceutical companies. Headquartered in Ingelheim, Germany, it
operates globally with 135 affiliates in 47 countries and 39,800
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 2007, Boehringer Ingelheim posted net sales of 10.9 billion
euro while spending 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
Related links:
http://www.news-ontarget.com
http://www.ontarget-telmisartan.com
http://www.micardis.com
References
1. The TRANSCEND Investigators. Effects of the
angiotensin-receptor blocker telmisartan on cardiovascular events in
high-risk patients intolerant to angiotensin-converting enzyme
inhibitors: a randomized controlled trial. Lancet Published online 31
August 2008.
2. The Heart Outcomes Prevention Evaluation Study Investigators.
Effects of an angiotensin-converting-enzyme inhibitor, ramipril, on
cardiovascular events in high-risk patients. N Engl J Med 2000;
342:145-53.
3. The ONTARGET investigators. Telmisartan, ramipril, or both in
patients at high risk for vascular events. N Eng J Med 2008;
358(15):1547-59.
4. Israili ZH, Hall WD. Cough and angioedema associated with
angiotensin-coverting enzyme inhibitor therapy. A review of the
literature and pathophysiology. Ann Intern Med 1992; 117(3):234-42.
5. Matchar DB, et al. Systematic Review: Comparative
effectiveness of angiotensin-converting enzyme inhibitors and
angiotensin II receptor blockers for treating essential hypertension.
Ann Intern Med 2008; 148:16-29.
6. Macaulay TE, Dunn SP. Cross-reactivity of
ACE-inhibitor-induced angioedema with ARBs. US Pharmacist 2007; 32
(2).
7. World Health Organization, Fact Sheet 317: Cardiovascular
Diseases February 2007.
http://www.who.int/mediacentre/factsheets/fs317/en/index.html
(Accessed August 2008)
8. Murray CJL, Lopez AD. eds. The Global Burden of Disease: A
comprehensive assessment of mortality and disability from diseases,
injuries, and risk factors in 1990 and projected to 2020. Cambridge;
Harvard University Press 2001.
9. Primary Prevention of Ischemic Stroke. A Guideline from the
American Heart Association/American Stroke Association Stroke
Council. Stroke 2006; 37:1583-1633.
* Telmisartan Randomised AssessmeNt Study in ACE-iNtolerant
subjects with cardiovascular Disease

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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