Telmisartan (MICARDIS(R)) as Effective as Ramipril But With Better Long-Term Tolerability in High-Risk Cardiovascular Asian Patients

Beijing (ots/PRNewswire) - New results from the landmark
ONTARGET(R) Trial show that, in Asian patients at high risk of
cardiovascular disease (CVD), telmisartan (MICARDIS(R)) 80mg is as
effective as, and significantly better tolerated than, ramipril 10mg
in reducing the risk of cardiovascular death, heart attack, stroke
and hospitalisation for congestive heart failure.(1) These
preliminary results were presented today at the 19th Great Wall -
International Cardiology Congress (GW-ICC) in Beijing, China.

Telmisartan and ramipril were equally protective in Asian and
non-Asian populations.(1) Of note, telmisartan was significantly
better tolerated than ramipril in this Asian population, with 19.9%
patients stopping their treatment permanently with ramipril compared
with only 14.4% patients treated with telmisartan (p=0.0004). Even
though only patients considered tolerant of both treatments were
selected to enter ONTARGET(R), 5.9% of patients on ramipril stopped
their treatment due to cough - an adverse reaction to ACE-inhibitors
- compared with only 1.4% of patients treated with telmisartan.(1)
Analysis will be conducted in the near future to further examine
these interesting findings.

Commenting on the results, Professor Tony Dans, the ONTARGET(R)
Trial coordinator for the Philippines, University of the Philippines
College of Medicine said, "The new ONTARGET data are very important
for treatment of Asian patients at risk of cardiovascular disease.
Long-term efficacy and tolerability of treatment in these patients is
of prime importance to ensure that they remain on their medication
and are well protected. Telmisartan is shown to be a very good
treatment option for these high-risk patients."

The ONTARGET(R) Trial involved over 25,620 patients globally,
including 3,137 patients from 79 centres across the Asia-Pacific
region, including 33 in China alone (other countries were Hong Kong,
Malaysia, Philippines, Singapore, South Korea, Taiwan,
Thailand).(1,2) Patients were already receiving standard care such as
statins, antiplatelet therapy and also betablockers and other
antihypertensive treatment, ensuring well-controlled blood pressure
from the beginning of the trial. All patients were considered to be
tolerant of ACE-inhibitors.(2)

ACE-intolerance in Asia Pacific

Worldwide, 10-39% of patients are intolerant to widely used
ACE-inhibitors, such as ramipril.(3-5) This effect is more pronounced
in the Asia-Pacific region, with studies showing that nearly half of
Chinese patients are intolerant to ACE-inhibitors.(6,7)

Professor Liu Lisheng, the ONTARGET(R) Trial coordinator for
China and President of the World Hypertension League, explained,
"Worldwide, cardiovascular disease accounts for 31.5% of all deaths
among women and 26.8% of all deaths among men. China alone has 160
million patients with hypertension and 160 million with high
cholesterol. However, the majority of patients with cardiovascular
disease do not receive appropriate treatment for many reasons, such
as inappropriate life style, low disease awareness and intolerance to
medication. The ambitious ONTARGET(R)/TRANSCEND(R) Trial programme is
the first head-to-head trial between ACE-inhibitors and ARBs
evaluating the efficacy and tolerability of these two different
treatments on long-term prognosis of cardiovascular diseases and
provides the medical community and the public with sufficient
evidence of both cardiovascular diseases treatment and prevention."

The ONTARGET Trial Programme - global results

The ONTARGET(R) Trial Programme comprises two parallel studies,
ONTARGET(R) and TRANSCEND(R) - data from the global patient dataset
were presented earlier this year:

- The ONTARGET(R) Trial results show that telmisartan 80mg is as
effective as the previous gold standard, ramipril 10mg, in protecting
against CV death, heart attack, stroke and hospitalisation for
congestive heart failure, is better tolerated and associated with
higher treatment compliance - whereas the combination of both
treatments, telmisartan and ramipril, did not provide an additional
benefit.(2)

- The TRANSCEND(R) Trial results show that telmisartan 80mg
significantly reduces the risk of CV death, heart attack and stroke
(by 13%) in ACE-intolerant patients already receiving current best
standard care.(8) The composite endpoint of CV death, heart attack,
stroke and hospitalisation for congestive heart failure was
non-significantly reduced by 8% (p=0.22).

Global burden of CVD

CVD is the leading cause of death worldwide, causing over 17.5
million deaths per year.(9) Half of the world's CVD burden is
predicted to occur in the Asia-Pacific region.(10) In 2002, over 2.3
million people in China died from CVD-related causes, the highest
number of deaths for one country in the world.(11) Global deaths from
CVD are predicted to reach approximately 25 million by 2020.(12) CVD
is also currently a leading cause of disability, and is predicted to
be the largest cause of disability worldwide by 2020.(12)

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) Dans A. Tolerance of telmisartan and ramipril amongst Asians
- The ONTARGET Trial. Presented at the 19th Great Wall International
Congress of Cardiology, Beijing, China, 23 October 2008.

(2) The ONTARGET investigators. Telmisartan, ramipril, or both in
patients at high risk for vascular events. N Eng J Med 2008;
358(15):1547-59.

(3) Israili ZH, Hall WD. Cough and angioedema associated with
angiotensin-converting enzyme inhibitor therapy. A review of the
literature and pathophysiology. Ann Intern Med 1992; 117(3):234-42.

(4) 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.

(5) Macaulay TE, Dunn SP. Cross-reactivity of
ACE-inhibitor-induced angioedema with ARBs. US Pharmacist 2007;
32(2).

(6) Woo J, Chan TY. A high incidence of cough associated with
combination therapy of hypertension with isradipine and lisinopril in
Chinese subjects. B J Clin Pract 1991; 45(3):178-80.

(7. Woo KS, Norris R, Nicholls G. Racial difference in incidence
of cough with angiotensin-converting enzyme inhibitors. Am J Cardiol.
1995; 75(14):967-8.

(8) 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. Lancet8 2008;
372:1174-118.

(9) .World Health Organization, Fact Sheet 317: Cardiovascular
Diseases February 2007.
http://www.who.int/mediacentre/factsheets/fs317/en/index.html
(Accessed August 2008).

(10) Lawes CM et al. Blood pressure and cardiovascular disease in
the Asia Pacific region. J Hypertens 2003; 21(4):673-5.

(11) World Health Organization, The Atlas of Heart Disease and
Stroke 2004. http://www.who.int/cardiovascular_diseases/resources/atl
as/en/index.html Accessed October 2008.

(12) 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.

ots Originaltext: Boehringer Ingelheim
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Contact: Dr. Reinhard Malin, Corporate Division Communications,
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