MUNICH, Germany, January 22 /PRNewswire/ --

- White Paper Addresses the Needs of These Challenging Patients

Less than a third of patients in Europe achieve acceptable blood pressure control. The remaining two thirds are challenging patients i.e. patients whose blood pressure physicians struggle to control. These are the alarming findings of a White Paper published in the Journal of Hypertension(1) by an international group of physicians calling for urgent action. The group met to discuss the daily challenges European physicians face in the current critical situation of hypertension control. The outcome is a consensus that continued failure to control hypertension inflicts an unacceptable yet avoidable toll on patients, families and society.

The group concluded: a challenging patient is in essence anyone with blood pressure of 140/90 mmHg or greater. Whilst the current perception is close to goal is acceptable, the reality is that the majority of challenging patients die prematurely or live with avoidable disability(2).

Chairman, Professor Josef Redon, Hospital Clinico, University of Valencia, Spain; commented on the meeting and subsequent White Paper: As a group we concluded that any patient with blood pressure of 140/90 mmHg or greater is at significant risk of cardiovascular disease progression, death and or disability. As it is a challenge to get these patients to goal BP these 'challenging patients' require persistent optimization of therapy until target blood pressure is achieved.

Inaction, or ineffective action, costs the EU community an estimated EUR192b annually(3). Control rates are significantly higher in other developed countries(4). To address the current critical situation key challenges were identified and effective solutions postulated, with a simple aim: to treat all challenging patients effectively to goal BP, preventing disability, saving lives and helping to relieve the financial burden of hypertension-driven cardiovascular disease.

The Challenges

Six key challenges in achieving goal BP were identified: (1) inadequate primary prevention; (2) faulty awareness of risk; (3) lack of simplicity of treatment; (4) therapeutic inertia; (5) insufficient patient empowerment; and (6) unsupportive healthcare systems.


To address the challenges identified in the White Paper, clinicians can take six effective actions to (i) identify and (ii) reduce the number of challenging patients:

- Acknowledge their challenging patients drive awareness of the dangers of hypertension across all sectors of society: get patients to BP goal quickly - Invest in substantial patient education - Make effective use of multidisciplinary team approaches - Encourage patients to take responsibility for their own cardiovascular health - Simplify treatment regimens by using the most effective and convenient option - Clinicians should take a leadership role in their communities, professions and society to effectively communicate the benefits of BP control

Simple, effective treatment gets challenging patients to goal

This finding of the White Paper is supported by the results of a randomised; double-blind multicentre study published in the latest issue of Clinical Drug Investigation(5), which investigated simple, flexible treatment regimens in a cohort of challenging patients.

The objective of the study was to determine the efficacy and safety of an olmesartan/amlodipine single daily pill (SEVIKAR(R)) combination therapy in patients with moderate to severe hypertension who had failed to respond to treatment with 8 weeks of amlodipine. At randomization almost 75% of these patients were in essence challenging patients, i.e. unable to achieve goal BP on amlodipine monotherapy.

The key findings highlight that SEVIKAR(R) resulted in higher BP reductions and rate of goal achievement than amlodipine 5 mg monotherapy in as little as 8 weeks after treatment. Indeed more than 70% of challenging patients on active combination therapy achieved their BP goal by week 24. Results also demonstrated that appropriate uptitration of SEVIKAR(R) led to further BP reductions and additional patients reaching BP goal, indicating the importance of simple, effective treatment regimens to provide the physician with flexibility to treat each individual patient's needs.

Importantly in an open-label period, the study demonstrated how SEVIKAR(R) can achieve impressive BP reductions and goal rates in a situation that is close to clinical practice, highlighting the importance of persistent optimization of therapy until target BP is achieved.

This study is the latest in a line of large, randomised clinical studies demonstrating the ability of SEVIKAR(R) to successfully treat patients with uncontrolled hypertension(6) (challenging patients) to the universally accepted BP goal of less than 140/90 mmHg - a threshold considered significant in reducing cardiovascular risk. (7),(8),(9)


DAIICHI SANKYO is a global pharmaceutical company that focuses on researching and marketing innovative medications. The company was created in 2005 through the merger of two traditional Japanese enterprises, Daiichi and Sankyo. With net sales of more than 5.4 billion EUR in fiscal year 2007, DAIICHI SANKYO is one of the world's 20 leading pharmaceutical companies. The company's world headquarters is in Tokyo, and its European base is located in Munich. DAIICHI SANKYO has affiliates in 12 European countries and has been one of the strongest Japanese pharmaceutical companies located in Europe since it set up European production facilities and marketing offices in 1990. The company's research activities focus on the areas of: cardiovascular diseases, hematology, diabetes, anti-infectives and cancer. Its aim is to develop medications that are best in their class or to create new classes of pharmaceutical drugs. For more information, please visit:

For more information on SEVIKAR(R) and The Challenging Patient, please visit: and

Forward-looking statements

This press release contains forward-looking statements and information about future developments in the sector, and the legal and business conditions of DAIICHI SANKYO EUROPE GmbH. Such forward-looking statements are uncertain and are subject at all times to the risks of change, particularly to the usual risks faced by a global pharmaceutical company, including the impact of the prices for products and raw materials, medication safety, changes in exchange rates, government regulations, employee relations, taxes, political instability and terrorism as well as the results of independent demands and governmental inquiries that affect the affairs of the company. All forward-looking statements contained in this release hold true as of the date of publication. They do not represent any guarantee of future performance. Actual events and developments could differ materially from the forward-looking statements that are explicitly expressed or implied in these statements. DAIICHI SANKYO EUROPE GmbH assumes no responsibility for the updating of such forward-looking statements about future developments of the sector, legal and business conditions and the company.


1. Redon etal. 2008 J Hypertens 26(12):S1-S14

2. Neal etal Lancet 2000;356:1955-64

3. Allender etal. European Heart Network 2008

4. Wang etal. Arch Intern Med 2007;167:141-7

5. Vople etal Clin Drug Investig. 2009;29(1):11-25

6. Chrysant etal. Clin Ther, 2008. 30(4): 587-604.

7. Mancia etal. J Hypertens 2007;25(6):1105-87.

8. WHO. The world health report 2002 - Reducing risks, promoting a healthy life.

9. Chobanian etal. JAMA 2003;289(19):2560-72.

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