/R E P E A T -- Canadian-led landmark trial shows MICARDIS(R) reduces the risk of cardiovascular death, heart attack and stroke in high-risk ACE-intolerant patients/



    
    TRANSCEND(R), part of the ONTARGET(R) Trial Program, confirms the
    protective benefits of MICARDIS in the broadest cross-section of
    cardiovascular high-risk patients receiving the best standard of care
    

    TORONTO, Aug. 31 /CNW/ - Results of the landmark TRANSCEND(R)(*) trial,
part of the ONTARGET(R) Trial Program, published online in the LANCET and
presented today at the European Society of Cardiology (ESC) in Munich, Germany
demonstrate that MICARDIS(R) 80mg once daily (telmisartan) significantly
reduces the risk of cardiovascular death, heart attack and stroke in high-risk
cardiovascular patients by 13 per cent compared with those already receiving
best standard of care (p=0.048). This is the same primary endpoint as the
landmark HOPE trial published in 2000.(1,2) Therapy with MICARDIS 80mg once
daily was well tolerated, and associated with a higher adherence than the best
standard of care over the study period of 56 months (median duration of follow
up).(1)
    In this study the high-risk patient included a broad cross-section of
cardiovascular (CV) patients (i.e. patients who were older than 55 years, had
a heart attack, peripheral arterial occlusive disease, stroke or transient
ischaemic attacks, or suffer from diabetes mellitus and additional risk
factors) - those patients commonly seen by Canadian physicians.
    The risk reduction of 13 per cent with MICARDIS 80mg once daily was
achieved despite patients receiving proven best standard of care therapies
such as statins, antiplatelet agents, diuretics and beta-blockers. TRANSCEND
is the only landmark trial to test and prove the CV protective effects of a
specific angiotensin II receptor blocker, Micardis 80 mg once daily, on top of
best standard of care in this high-risk patient population, who cannot
tolerate an angiotensin converting enzyme (ACE)-inhibitor.
    In TRANSCEND all CV hospitalisations were significantly reduced (894 vs.
980; p=0.025) with MICARDIS 80mg once daily. Furthermore, the data show the
protective effects of MICARDIS 80mg once daily were more pronounced the longer
patients were on treatment.(1)
    The pre-specified primary endpoint, the composite of CV death, heart
attack, stroke and hospitalization for congestive heart failure, was reduced
by 8 per cent (p = 0.216 = non statistical significance (HR 0.92)).(1) In
other words, 465 patients in the MICARDIS 80mg once daily arm experienced a
cardiovascular event versus 504 patients in the best standard of care arm.
    "Earlier this year, the ONTARGET Trial showed that telmisartan is as
protective as, but better tolerated than the ACE-inhibitor ramipril. The
TRANSCEND results represent a moderate but important step forward for
high-risk patients who cannot tolerate an ACE-inhibitor," commented Prof.
Salim Yusuf, lead investigator of the ONTARGET Trial Program and Director of
the Population Health Research Institute at McMaster University, Hamilton,
Ontario.
    "TRANSCEND confirms patients receiving the best cardiovascular treatments
available today can be further protected from CV death, heart attacks and
stroke with the addition of Micardis," said Dr. Guy Proulx, Cardiologist at
the Institute of Cardiology and Pneumology, Laval Hospital, Québec City,
Québec and one of the Canadian investigators in the ONTARGET Trial Program.
"Evidence from both the ONTARGET and TRANSCEND trials establish Micardis as
the proven option for the broadest cross-section of CV high-risk patients."

    About TRANSCEND

    TRANSCEND, led out of McMaster University in Hamilton, Ontario, is a
parallel study to the ONTARGET(R) trial(3), which together form The
ONTARGET(R) Trial Program.. TRANSCEND investigated the effects of MICARDIS
80mg once daily in 5,926 patients in 40 countries (including 426 patients in
Canada) 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)

    About cardiovascular disease: Canada's number one killer

    Cardiovascular disease (CVD) is the leading cause of death in Canada,
causing over 72,000 deaths per year. Each year, 18,000 people die from a heart
attack and over 14,000 die from a stroke.(7) CVD is also the leading cause of
death worldwide, causing over 17.5 million deaths per year.(8) Global deaths
from CVD are predicted to reach approximately 25 million by 2020. CVD is also
currently a leading cause of disability, and it is predicted that it will be
the largest cause of disability worldwide by 2020.(9) A major stroke is viewed
by more than half of those at risk as being worse than death.(10)

    About MICARDIS

    MICARDIS 80mg once daily is a modern member of the Angiotensin II
Receptor Blocker (ARB) class and is being investigated in the most ambitious
and far-reaching research program conducted with an ARB. The ONTARGET Trial
Program, plus additional protection programs, have investigated the CV
protective effects of MICARDIS in over 58,000 patients over the last 5 years,
summing up to 25 million patient years worldwide. MICARDIS was discovered and
developed by Boehringer Ingelheim. Under the trademarks MICARDIS(R) and
MICARDIS PLUS(R) (combination with hydrochlorothiazide) the company markets
telmisartan in 84 countries around the world.

    About 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. For more information
please visit www.boehringer-ingelheim.com

    Related links:

    www.news-ontarget.com; www.ontarget-telmisartan.com; www.micardis.com
www.news-landmarktrials.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.  Heart & Stroke Foundation. (n.d.). Statistics. Retrieved August 28,
        2008 from http://www.heartandstroke.com/site/c.ikIQLcMWJtE/b.3483991/
        k.34A8/Statistics.htm
    8.  World Health Organization, Fact Sheet 317: Cardiovascular Diseases
        February 2007.
        http://www.who.int/mediacentre/factsheets/fs317/en/index.html
        (Accessed August 2008)
    9.  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.
    10. 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
    




For further information:

For further information: Alison O'Mahony, Jeanelle Frampton, Environics
Communications, (416) 969-2745, 2760, aomahony@environicspr.com,
jframpton@environicspr.com

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