More Than Half of Hypertensive Patients Remain Uncontrolled and at Higher Risk of Heart Attack and Stroke - Telmisartan May Decrease This Risk

2007-06-18 09:29 602

- 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


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.

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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.

Source: Boehringer Ingelheim