First Study to Show Long-Term Efficacy and Tolerability of an ARB -
Telmisartan (MICARDIS(R)) - in Asian Patients
BEIJING, Oct. 23 /CNW/ - 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-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
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Please take account of this when referring to the information provided in this
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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.
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
(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
(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-
(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. 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.
(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
(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
x.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.
For further information:
For further information: Dr. Reinhard Malin, Corporate Division
Communications, Boehringer Ingelheim GmbH, 55216 Ingelheim/Germany, Phone: +
49-6132-77-97296, 77-90815, Fax: + 49-6132-72-6601, E-mail: