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)
31/08/2008 12:31
PR Newswire
MUNICH, Germany, August 31 /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)
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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 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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