MILAN, ITALY, June 18 /CNW/
- For non-US Healthcare Media
- Results From Two Large, Multinational, Practice-Based Observational
Studies in Blood Pressure
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 ((less than
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 (greater than)26,000 patients with hypertension (office blood pressure
(greater than)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(less than)0.001),
almost doubling the number of patients with controlled blood pressure
from 36.5% to 64.4% ((less than)135/85mmHg, ESH/ESC) after 8 weeks of
- The 24-hour ABP was reduced by telmisartan alone and in combination
with HCTZ by -7.85/-4.7 mmHg (p(less than)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 - 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
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.
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
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referring to the material.
(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,
(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 further information:
For further information: Ute Schmidt, Corporate Division Communications,
Boehringer Ingelheim GmbH, 55216 Ingelheim/Germany, Phone: +49-6132-77-97296,
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