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New Study Demonstrates Patients Who Were Informed of Their Risk of Cardiovascular Disease Lowered Their Predicted Risk for Coronary Heart Disease

This new study confirms that more patient education about cardiovascular risk should be part of normal care

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VIENNA, Austria, September 3 – A new Pfizer sponsored study demonstrated that a patient-focused, physician-implemented coronary heart disease (CHD) risk evaluation and communication program significantly lowered the Framingham 10-year calculated CHD risk by 11.7 percent, compared to usual care. This prospective multinational study of 1,100 patients in nine European countries was presented today at the European Society of Cardiology (ESC) Congress 2007. This study confirms that communicating with patients about their calculated risk and informing them of the implications may encourage patients to make changes to reduce their overall cardiovascular risk.[1]

The REACH-OUT (Risk, Evaluation and Communication Health Outcomes and Utilization Trial) study randomized physicians into two groups. The physicians in the communication program group provided their patients with a risk evaluation using a Framingham CHD risk calculator, educated them about their results and informed them of strategies to control their risk over a six month period. The physicians in the control group neither informed the patients of their risk nor provided risk evaluation and the patients received usual care. Both patient groups received cardiovascular medications during the study in accordance with the physician’s clinical judgement.1

"The REACH-OUT study supports the need for global CHD risk assessment and risk factor education for managing total cardiovascular health," said Pfizer Inc. Medical Director, Jan Buch. "These results suggest that when physicians inform their patients of their CV risk as part of their overall CV treatment regimen, the risk of cardiovascular events may be significantly reduced. However, the 11.7 percent risk reduction did not normalize the patient risk, so additional measures to improve the therapy are needed."

Key Points from the Prospective Study1

· The communication program group achieved an 11.7 percent statistically significant relative reduction in calculated risk (95% CI: -10.44, -13.05) compared with the group that received usual care.

o The communication program group lowered its mean calculated absolute Framingham risk from 17.2 percent to 12.5 percent (a 27 percent relative risk reduction).

o The usual care group lowered their mean calculated absolute Framingham risk from 16.9 percent to 13.7 percent (a 19 percent relative risk reduction).

o The communication program group showed a 20 mm Hg reduction in systolic blood pressure, versus a 15 mm Hg reduction in the usual care group, while LDL cholesterol was lowered by 10 and 7 percent respectively.

o Twenty five percent of the communication program group reached both their target blood pressure and LDL cholesterol goals, versus 14 percent of the usual care group.

o At baseline 90 percent of the patients were taking cardiovascular medications.

Total CV Risk Management

A comprehensive approach to cardiovascular risk assessment and management ideally begins with assessment of total cardiovascular risk. The concept of overall cardiovascular risk includes the combined impact of multiple cardiovascular risk factors, rather than the impact of each risk factor alone. Recent evidence suggests that multiple risk factor reduction of overall cardiovascular risk markedly decreases cardiovascular events, compared with addressing individual risk factors.[2]

Physicians can estimate 10-year coronary heart disease risk (Framingham risk) by assessing the major risk factors or characteristics that contribute to CHD, including hypertension, high blood pressure, high cholesterol, smoking, diabetes, obesity, family history, gender and age.[3]

Current guidelines, including the new ESC guidelines unveiled at this Congress, recognize that the health outcomes of millions of individuals with cardiovascular risk factors who are vulnerable to strokes and heart attacks can only be improved through an integrated approach that addresses overall cardiovascular risk.[4]

"It is crucial to educate patients about their cardiovascular risk," said cardiologist, Dr Leif Erhardt. "However, in addition we need to continue to address cardiovascular risk through more aggressive treatment, including drug therapy that can treat multiple risk factors."

Optimal Treatment Necessary for Reducing Total CV Risk

This study demonstrates that evaluating and communicating with patients about their calculated CHD risk and informing them of the implications may reduce a patient’s overall risk. In addition, current evidence suggests that treatment of a single risk factor is suboptimal and that reduction of multiple CV risk factors decreases CV events more than single risk factor reduction alone. These study results, coupled with published evidence, support the need for more aggressive treatment of multiple risk factors and suggest that an integrated approach of education and more aggressive CV risk management is necessary to reduce the overall risk of heart attack and stroke.[5]

Pfizer is the world's largest research-based pharmaceutical company taking new approaches to better health. We discover and develop innovative medicines to treat and help prevent disease for both people and animals. Through consistent, high-quality manufacturing and distribution operations, our medicines reach patients in 180 nations. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality healthcare and health system support. At Pfizer, our colleagues work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide.

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[1] A program to evaluate and communicate 10-yr risk of CHD reduces predicted risk versus usual care: The Risk evaluation and Communication Health Outcomes and Utilization Trial (REACH OUT). To be presented at ESC.

[2] Risk Evaluation and Comunication Health Outcomes and Utilization Trial REACH OUT Power Point Presentation; Slide 4. 1Wilson et al. Circulation 1998;97:1837-47; 2Conray et al. Eur Heart J 2003;24:987-1003; 3Assman et al. Circulation 2002; 105;310-5

[3] American Heart Association. Risk Factors and Coronary Heart Disease. American Heart Association website. Accessed 8/22/2007. http://www.americanheart.org/presenter.jhtml?identifier=4726

[4] The Gateway to Managing Total CV Risk Power Point Presentation; Slide 17- De Backer G et al. Eur Heart J. 2003;24:1601-1610. World Health Organization. J Hypertens. 2003;21:1983-1992. Williams B et al. Hum Hypertens. 2004;18:139-185. 2003 European Society of Hypertension. J Hypertens. 2003;21:1011-1053. Grundy SM et al. Circulation. 2004;110: 227-239. Chobanian AV et al. Hypertens. 2003;42:1206-1252. CHEP Recommendations for the management of Hypertension 2005. Available at www.hypertension.ca/recommendations_2005/ultrashortexecsummary2005.pdf. Accessed April 10, 2006. Joint British Societies’ guidelines on prevention of cardiovascular disease in clinical practice. Available at: heart.bmjjournals.com. Accessed 14 March 2006.

[5] Kostis, John B. The Importance of Managing Hypertension and Dyslipidemia to Decrease Cardiovascular Disease. Cardiovascular Drugs and Therapy: 0920-3206 (print) 1573-7241 (online). June 29, 2007.

Contact:

Oliver Stohlman
001 917 386 4650

oliver.stohlmann@pfizer.com

Posted: September 2007

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