MICARDIS(R)- Based Regimens Help More Patients Achieve Their Blood Pressure Goals



    
    -  For non-US Healthcare Media and non-UK Healthcare Media

    -  New Studies Show Benefits of MICARDIS(R) (Telmisartan) in Combination
       With Amlodipine and Hydrochlorothiazide
    

    BERLIN, June 18 /CNW/ - The results of two new studies of MICARDIS(R)
(telmisartan) in free combination with amlodipine or fixed combination with
hydrochlorothiazide (HCTZ) 25 mg confirm that a telmisartan-based approach to
treating hypertensive patients at risk of cardiovascular events can provide
powerful and sustained blood pressure control in a broad range of people,
including those who are difficult-to-treat.(1-5) The study results were
presented today at the 18th Scientific Meeting of the European Society of
Hypertension and the 22nd Scientific Meeting of the International Society of
Hypertension, held in Berlin, Germany.
    Commenting on the results, Professor Thomas Unger, Chair of Pharmacology
and Director of the Institute of Pharmacology at the Charite -
Universitatsmedizin Berlin, said, "Controlling patients' blood pressure is a
challenge that usually needs more than one antihypertensive to achieve optimal
control. Telmisartan already provides proven effective blood pressure lowering
and cardio & vascular protection in a broad range of patients at high-risk of
cardiovascular disease. These new blood pressure studies now show that
combining telmisartan with other antihypertensive treatments - amlodipine and
hydrochlorothiazide - that act via different mechanisms, may reduce the risk
of heart attack or stroke even further."

    "Round the clock" powerful blood pressure lowering with telmisartan and
    amlodipine combination

    In a study combining telmisartan (a modern angiotensin II receptor 
blocker, ARB) and amlodipine (the most widely-used calcium channel blocker,
CCB) 1,461 patients were randomized to receive treatment with a combination of
telmisartan 0 (placebo), 20, 40, or 80 mg plus amlodipine 0 (placebo), 2.5, 5
or 10 mg.(1)
    After 8 weeks, significant blood pressure reductions were observed for
all combinations of clinical interest (telmisartan 40 or 80 mg plus amlodipine
5 or 10 mg; p(less than)0.05) with the greatest reductions (-26.4/-20.1 mmHg)
shown and greatest blood pressure control rate (76.5% patients) achieved by
telmisartan 80 mg in combination with amlodipine 10 mg.(1) All treatment
combinations were well tolerated.(4)
    A substudy of 562 patients confirmed that 24-hour "round the clock" blood
pressure control rate (measured by ambulatory blood pressure monitoring) with
the combination of telmisartan and amlodipine, including the early morning
hours when uncontrolled blood pressure is known to put patients at greatest
risk of a heart attack or stroke, was up to twice the rate of that achieved
with the monotherapy compounds.(2)

    Difficult-to-treat patients benefit from fixed-dose combination of
    telmisartan 80 mg/HCTZ 25 mg

    In a second long-term study, patients with essential hypertension and
whose blood pressure had not previously been adequately controlled, received
treatment with either telmisartan 80 mg/HCTZ 25 mg (n equals 321) or
telmisartan 40 mg/HCTZ 12.5 mg (n equals 318).(5)
    After 24-weeks treatment with telmisartan 80 mg/HCTZ 25 mg, the
percentage of patients achieving blood pressure control (DBP (less than)90
mmHg) increased from 52.4% at the study start to 71.4%.(5) The increase in
control was observed very early (at 4 weeks), was maintained until the study
end, at which point most patients (85.6%) did not require additional
antihypertensive therapy. Treatment was well tolerated.(5)
    The fixed-dose combination of telmisartan 80 mg/HCTZ 25 mg was recently
approved by the European Commission for difficult-to-treat patients whose
blood pressure is not adequately controlled with telmisartan/HCTZ lower dose.

    Proven cardio & vascular protection and tolerability shown in recent
    ONTARGET(R) trial

    Telmisartan is the only angiotensin II receptor blocker (ARB) proven to
achieve effective blood pressure lowering AND to have proven cardio & vascular
protective benefits in a broad range of high-risk cardiovascular patients.(6)
The first results of the ONTARGET(R) Trial, presented earlier this year at ACC
2008, demonstrated that telmisartan was as protective as ramipril (the
previous gold standard) in terms of reducing the risk of cardiovascular death,
myocardial infarction, stroke and hospitalisation for congestive heart failure
in a broad cross-section of high-risk patients and was better tolerated.(6)
    Telmisartan also provides superior blood pressure lowering power compared
with the ARBs losartan(7) and valsartan8and has also been shown to achieve
blood pressure reductions at least as efficacious as leading antihypertensives
of other classes, including enalapril, lisinopril, ramipril, amlodipine and
atenolol.(9-13)

    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.

    Addressing the world's largest healthcare burden

    Cardiovascular disease (CVD) is the leading cause of death worldwide,
causing over 17.5 million deaths per year.(14) 7.6 million people die from a
heart attack and 5.7 million die from a stroke every year.(4) Global deaths
from CVD are predicted to reach approximately 25 million by 2020.(15) CVD is
also currently a leading cause of disability, and is predicted to be the
largest cause of disability worldwide by 2020.(15) A major stroke is viewed by
more than half of those at risk as being worse than death.(16)

    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.

    About ONTARGET(r)

    The ONTARGET(r) Trial Programme consists of two randomised, double-blind,
multicentre international trials: the principle trial, ONTARGET(r) which has
reported its results on 31 March 2008, and a parallel trial TRANSCEND(r)
(Telmisartan Randomized AssessmeNt Study in ACE-I INtolerant subjects with
cardiovascular Disease), which is planned to be reported later in the year.(6)
    The treatment arms for the ONTARGET(r) Trial were telmisartan 80mg,
ramipril 10mg, and combination therapy with telmisartan 80mg and ramipril
10mg. In the TRANSCEND(r) trial the treatment arms are telmisartan 80mg or
placebo - both on top of standard blood pressure care, not including an ACE or
another ARB.(6),(17)
    Patients enrolled in The ONTARGET(r) Trial Programme were aged more than
or equal to 55 years, had a history of coronary artery disease, stroke or
recent (greater than 7 days, less than 1 year) transient ischaemic attack,
peripheral vascular disease, or diabetes mellitus with target-organ damage
such as microalbuminuria, ankle-brachial index (less than) 0.8, or left
ventricular hypertrophy.(17)

    The ONTARGET(r) Trial had a four-fold composite endpoint:

    - cardiovascular death,
    - myocardial infarction,
    - stroke, and
    - hospitalisation for heart failure.

    Patients intolerant to ACEs were not eligible for the ONTARGET(r) study.
Intolerance to ACE was a requirement for enrolment into TRANSCEND(r).
    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)  Littlejohn T et al. Superior antihypertensive efficacy of the
         combination of telmisartan and amlodipine versus respective
         monotherapies in patients with hypertension: results of a factorial
         design study. Poster presented at 18th Scientific Meeting of the
         European Society of Hypertension and the 22nd Scientific Meeting of
         the International Society of Hypertension; Berlin, Germany,
         June 18 2008.

    (2)  Littlejohn T et al. Telmisartan and amlodipine combination therapy
         is powerful at lowering 24 hour blood pressure: findings of an ABPM
         substudy in hypertensive patients. Poster presented at 18th
         Scientific Meeting of the European Society of Hypertension and the
         22nd Scientific Meeting of the International Society of
         Hypertension; Berlin, Germany, June 16 2008.

    (3)  Littlejohn T et al.Telmisartan and amlodipine combination provides
         an effective treatment option for patients with moderate or severe
         hypertension: subanalysis from a factorial design study Poster
         presented at 18th Scientific Meeting of the European Society of
         Hypertension and the 22nd Scientific Meeting of the International
         Society of Hypertension; Berlin, Germany, June 18 2008.

    (4)  Littlejohn T et al. Effect of telmisartan addition to amlodipine on
         reduction of incidence of peripheral edema and orthostatic BP
         changes: safety analysis. Poster presented at 18th Scientific
         Meeting of the European Society of Hypertension and the 22nd
         Scientific Meeting of the International Society of Hypertension;
         Berlin, Germany, June 18 2008.

    (5)  Neldam S et al. Efficacy and safety of telmisartan 80mg/HCTZ 25mg
         fixed-dose combination, alone or with other antihypertensive
         medications, during open-label, long-term treatment. Poster
         presented at 18th Scientific Meeting of the European Society of
         Hypertension and the 22nd Scientific Meeting of the International
         Society of Hypertension; Berlin, Germany, June 18 2008.

    (6)  The ONTARGET investigators. N Eng J Med 2008; 358(15):1547-59.

    (7)  Mallion JM. J Hum Hypertens 1999; 13:657-64.

    (8)  Lacourciere Y et al. Blood Press Monit 2004; 9:203-10.

    (9)  Parati GF et al. Presented at the Annual Meeting of the European
         Society of Hypertension. June 2006, Madrid, Spain.

    (10) Neutel JM et al. Am J Ther 1999; 6:161-6.

    (11) Freytag F et al. Clin Ther 2001; 23:108-23.

    (12) Lacourciere Y et al. Blood Press Monit 1998; 3:295-302.

    (13) Williams B et al. Br J Hypertens 2006; 24:193-200.

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

    (15) 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.

    (16) Primary Prevention of Ischemic Stroke. A Guideline From the American
         Heart Association/American Stroke Association Stroke Council. Stroke
         2006; 37:1583-1633.

    (17) The ONTARGET/TRANSCEND Investigators. Am Heart J 2004; 148(1):52-61.
    





For further information:

For further information: Reinhard Malin, Corporate Division
Communications, Boehringer Ingelheim GmbH, 55216 Ingelheim/Germany, Tel.:
+49-6132-77-90815, Fax: +49-6132-72-6601, E-mail:
reinhard.malin@boehringer-ingelheim.com

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