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2007'06.19.Tue
More Than Half of Hypertensive Patients Remain Uncontrolled and at Higher Risk of Heart Attack and Stroke - Telmisartan May Decrease This Risk
June 18, 2007



    - Results From Two Large, Multinational,
Practice-Based
      Observational Studies in Blood Pressure

    MILAN, Italy, June 18 /Xinhua-PRNewswire/ -- New data
announced today at the Annual European Society of
Hypertension (ESH) show that measuring blood pressure in a
doctor's office alone does not provide an accurate picture
of a patient's blood pressure control. Treatments utilised
only on this basis are likely to leave many people at
increased risk of heart attack, stroke or even
cardiovascular death. According to a further study also
presented today, this "unnecessary" additional
risk could be avoided by choosing a treatment regimen like
once daily telmisartan, which provides smooth blood
pressure control over a full 24 hour period, including the
risky morning hours.

    Results from the SURGE hypertension study, an
observational study of blood pressure control outside of a
clinical setting, demonstrate that:(1,2)
    
    - More than 60% of patients do not have controlled
    (<135/85mmHg, ESH/ESC) blood pressure in the morning
when measured by
    home blood pressure monitoring (HBPM).

    - Again, more than 60% of patients are not able to
achieve control
    of blood pressure peaks over a 24-hour period, when
measured by
    ambulatory blood pressure (ABPM), which monitors
control over the full
    24-hour period.

    Professor Gianfranco Parati, University of
Milano-Bicocca, Italy, Chair of the SURGE Steering
Committee commented, "The SURGE study is noteworthy
because it illustrates that in a real-life setting, despite
receiving treatment, a large proportion of patients still
have poorly controlled hypertension, particularly in their
morning hours. It also highlights the challenges physicians
face in getting an accurate picture of blood pressure as
HBPM and, even more so, ABPM can not be implemented
routinely in every patient in daily practice. What we
really need are reliable therapies that provide consistent
control over a full 24 hour period."

    SURGE-2, an 8-week, open-label prospective,
practice-based study, assessed the effects of the
angiotensin II receptor blocker (ARB) telmisartan in
>26,000 patients with hypertension (office blood
pressure >140/90mmHg). Blood pressure control was
measured using either HBPM (n=25,882) or ABPM (n= 863).
    The results(3,4) from this observational study, the
largest practise-based study ever conducted in hypertension
using this methodology, demonstrate that telmisartan
provides powerful blood pressure control over a full
24-hour period, including the risky early morning
hours(3,4):
    
    - The mean morning ABP was significantly reduced by
telmisartan
    alone and in combination with HCTZ by -8.2/-4.9 mmHg
(p<0.001), almost
    doubling the number of patients with controlled blood
pressure from 
    36.5% to 64.4% (<135/85mmHg, ESH/ESC) after 8 weeks
of treatment.

    - The 24-hour ABP was reduced by telmisartan alone and
in
    combination with HCTZ by -7.85/-4.7 mmHg (p<0.001).

    Professor Parati comments, "The results from
SURGE-2 are particularly encouraging. They demonstrate
that, unlike many other antihypertensive treatments, in
telmisartan we have a treatment option that does provide
smooth blood pressure control from morning to morning. This
is expected to lead to prevention of heart attacks, strokes
and even cardiovascular death."

    The SURGE studies (SURGE and SURGE-2) are part of an
extensive ongoing clinical trial programme, with
observational as well as clinical studies investigating the
outstanding effects of telmisartan compared with other
treatments for hypertension, including other available
ARBs. These trials investigate the effects of telmisartan
in providing powerful blood pressure reduction from morning
to morning, potential organ-protective effects and
cardiometabolic protective properties.

    Telmisartan has a longer duration of action than all
other members of the ARB class; it takes approximately 24
hours for half the dose of telmisartan to be eliminated
from the body compared to five to 15 hours for other
ARBs(5,6). Clinical trials have already shown that
telmisartan provides powerful and consistent blood pressure
reduction over a full 24  hour period(5-8).

    The results of the SURGE studies in a real life setting
further support the hypothesis that, due to its unique
pharmacological profile, telmisartan could provide a
solution for the ongoing problem of risky blood pressure
surges in the morning. Ultimately, telmisartan may give
doctors an effective option to protect their hypertensive
patients from cardio- and cerebrovascular events 24 hours a
day.

    Notes to Editors

    About organ damage

    Complications occurring as a result of uncontrolled
hypertension can lead to organ damage.
    
    BRAIN    Prolonged uncontrolled hypertension puts the
individual at
             greater risk of encountering a stroke.
    HEART    Hypertension increases the workload of the
heart. Prolonged
             increase of the workload will eventually
result in the
             enlargement of the heart and increases the
risk of heart
             failure and heart attack.
    KIDNEYS  Prolonged hypertension may eventually result
in kidney
             failure, which in the end-stage may
necessitate dialysis
             treatment.
    EYES     Hypertension can damage the blood vessels in
the retina and
             may result in visual impairment and/or loss of
vision.

    SURGE studies

    SURGE - Survey with HBPM and ABPM Under Real clinical
conditions in General practice to Evaluate blood pressure
control in the early morning.

    An observational study to assess early morning blood
pressure control in hypertensive patients

    SURGE-2 - Study of a hypertensive population Under
treatment with  telmisartan in Real clinical conditions
with the Goal of controlling Early  morning blood pressure
rise. A surveillance study of the efficacy of  telmisartan
(MICARDIS(R)) treatment in reducing early morning blood
pressure  under real clinical conditions.

    About telmisartan (Micardis(R)/Kinzal(R)/Pritor(R))

    Telmisartan is a member of the angiotensin II receptor
blocker (ARB) class and is being investigated in the most
ambitious and far-reaching research programme ever
conducted with an ARB. In the ongoing clinical trial
programmes ONTARGET, PROTECTION and PRoFESS, over 58,000
patients have been enrolled to investigate the
cardiovascular protective effects of telmisartan.
    Telmisartan was discovered and developed by Boehringer
Ingelheim. Under  the trademarks MICARDIS(R) and
MICARDISPLUS(R) (combination with HCTZ) 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. Bayer HealthCare promotes telmisartan under the
brand names Kinzalmono(R), Kinzalkomb(R) (combination with
HCTZ), and Pritor(R) and PritorPlus(R) in markets across
Europe. Pritor(R) and PritorPlus(R) is also marketed by
GlaxoSmithKline in selected markets.

    Boehringer Ingelheim

    The Boehringer Ingelheim group is one of the world's 20
leading pharmaceutical companies. Headquartered in
Ingelheim, Germany, it operates globally with 137
affiliates in 47 countries and 38,400 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 2006, Boehringer Ingelheim posted net sales of 10.6
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
www.boehringer-ingelheim.com

    Please be advised

    This release is from the Corporate Headquarters of
Boehringer Ingelheim and is intended for all international
markets. This being the case, please be aware that there
may be some differences between countries regarding
specific medical information including licensed uses.
Please take account of this when referring to the
material.

    References

    1. Parati G et al. Morning and smooth 24 hour
ambulatory blood pressure control is not achieved in high
risk patients with hypertension: results from the SURGE
observational study. Presented at the Annual Meeting of the
European Society of Hypertension. June 2007, Milan, Italy.

    2. Redon J et al. Home blood pressure control is low
during the critical morning hours in patients with
hypertension and even worse in high-risk patients with
diabetes and left ventricular hypertrophy: results from the
SURGE observational study. Presented at the Annual Meeting
of the European Society of Hypertension. June 2007, Milan,
Italy.

    3. Parati G et al. Telmisartan improves and maintains
smooth ambulatory blood pressure control over 24 hours in
the morning: Results from a practice based study (SURGE-2).
Presented at the Annual Meeting of the European Society of
Hypertension. June 2007, Milan, Italy.

    4. Redon J et al. Telmisartan procudes smooth home
blood pressure reduction, even during the critical early
morning hours: results from a post-marketing study
(SURGE-2). Presented at the Annual Meeting of the European
Society of Hypertension. June 2007, Milan, Italy.

    5. Burnier M, Brunner HR. Lancet 2000;355:637-45.

    6. Brunner HR. J Hum Hypertens 2002;16(suppl
2):S13-S16.

    7. Neutel JM, Smith HG. J Clin Hypertens
2003;5(1):58-63.

    8. Millar-Craig MW et al. Lancet 1978;1:795-97.


    For more information, please contact: 

     Ute Schmidt
     Corporate Division Communications
     Boehringer Ingelheim GmbH, 55216 Ingelheim/Germany,
     Tel:   +49-6132-77-97296
     Fax:   +49-6132-72-6601
     Email: press@boehringer-ingelheim.com
     Web:   http://www.boehringer-ingelheim.com

PR
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