2007-06-18

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


Milan, Italy (ots/PRNewswire) -

- For non-US Healthcare Media

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

New data announced today at the Annual European Society ofHypertension (ESH) show that measuring blood pressure in a doctor'soffice alone does not provide an accurate picture of a patient'sblood pressure control. Treatments utilised only on this basis arelikely to leave many people at increased risk of heart attack, strokeor even cardiovascular death. According to a further study alsopresented today, this "unnecessary" additional risk could be avoidedby choosing a treatment regimen like once daily telmisartan, whichprovides smooth blood pressure control over a full 24 hour period,including the risky morning hours.

Results from the SURGE hypertension study, an observational studyof blood pressure control outside of a clinical setting, demonstratethat:(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 isnoteworthy because it illustrates that in a real-life setting,despite receiving treatment, a large proportion of patients stillhave poorly controlled hypertension, particularly in their morninghours. It also highlights the challenges physicians face in gettingan accurate picture of blood pressure as HBPM and, even more so, ABPMcan not be implemented routinely in every patient in daily practice.What we really need are reliable therapies that provide consistentcontrol 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 bloodpressure >140/90mmHg). Blood pressure control was measured usingeither HBPM (n=25,882) or ABPM (n= 863).

The results(3,4) from this observational study, the largestpractise-based study ever conducted in hypertension using thismethodology, demonstrate that telmisartan provides powerful bloodpressure control over a full 24-hour period, including the riskyearly 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 areparticularly encouraging. They demonstrate that, unlike many otherantihypertensive treatments, in telmisartan we have a treatmentoption that does provide smooth blood pressure control from morningto 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 extensiveongoing clinical trial programme, with observational as well asclinical studies investigating the outstanding effects of telmisartancompared with other treatments for hypertension, including otheravailable ARBs. These trials investigate the effects of telmisartanin providing powerful blood pressure reduction from morning tomorning, potential organ-protective effects and cardiometabolicprotective properties.

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

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

Notes to Editors

About organ damage

Complications occurring as a result of uncontrolled hypertensioncan 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 conditionsin General practice to Evaluate blood pressure control in the earlymorning.

An observational study to assess early morning blood pressurecontrol in hypertensive patients

SURGE-2 - Study of a hypertensive population Under treatment withtelmisartan in Real clinical conditions with the Goal of controllingEarly morning blood pressure rise. A surveillance study of theefficacy of telmisartan (MICARDIS(R)) treatment in reducing earlymorning 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 andfar-reaching research programme ever conducted with an ARB. In theongoing clinical trial programmes ONTARGET, PROTECTION and PRoFESS,over 58,000 patients have been enrolled to investigate thecardiovascular protective effects of telmisartan.

Telmisartan was discovered and developed by Boehringer Ingelheim.Under the trademarks MICARDIS(R) and MICARDISPLUS(R) (combinationwith HCTZ) the company markets telmisartan in 84 countries around theworld, including the USA, Japan and European countries. Telmisartanis marketed in cooperation with Astellas Pharma Inc. in Japan, BayerHealthCare in Europe and GlaxoSmithKline in selected markets. BayerHealthCare promotes telmisartan under the brand names Kinzalmono(R),Kinzalkomb(R) (combination with HCTZ), and Pritor(R) andPritorPlus(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 leadingpharmaceutical companies. Headquartered in Ingelheim, Germany, itoperates globally with 137 affiliates in 47 countries and 38,400employees. Since it was founded in 1885, the family-owned company hasbeen committed to researching, developing, manufacturing andmarketing novel products of high therapeutic value for human andveterinary medicine.

In 2006, Boehringer Ingelheim posted net sales of 10.6 billioneuro while spending one fifth of net sales in its largest businesssegment 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 BoehringerIngelheim and is intended for all international markets. This beingthe case, please be aware that there may be some differences betweencountries regarding specific medical information including licenseduses. Please take account of this when referring to the material.

References

1. Parati G et al. Morning and smooth 24 hour ambulatory bloodpressure control is not achieved in high risk patients withhypertension: results from the SURGE observational study. Presentedat the Annual Meeting of the European Society of Hypertension. June2007, Milan, Italy.

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

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

4. Redon J et al. Telmisartan procudes smooth home blood pressurereduction, even during the critical early morning hours: results froma post-marketing study (SURGE-2). Presented at the Annual Meeting ofthe 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.

ots Originaltext: Boehringer IngelheimIm Internet recherchierbar: http://www.presseportal.de

Contact:Contact: Ute Schmidt, Corporate Division Communications, Boehringer Ingelheim GmbH, 55216 Ingelheim/Germany, Phone: +49-6132-77-97296, Fax: +49-6132-72-6601, E-mail: press@boehringer-ingelheim.com

Boehringer Ingelheim

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

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