2009-08-31 ESC Congress 2009

New data highlight continuing underuse of low-dose aspirin despite wealth of evidence and wide advocacy of its benefits in CVD prevention

Barcelona, Spain, August 31, 2009 – New data confirming the serious health and economic consequences of aspirin underutilisation in the prevention of cardiovascular disease (CVD) were presented today at a press conference held by Bayer Schering Pharma at the ESC Congress 2009. A panel of experts discussed new results from the Aspirin Underutilisation and Compliance in CVD Treatment (ACT) study in the context of other recent research on low-dose aspirin in the prevention of CVD, and emphasised the need to broaden the use of aspirin therapy to help reduce the global burden of deaths and disability due to CVD.

The ACT study – based on the response of 7,363 physicians in 18 countries across Europe, Asia-Pacific and South America to an online questionnaire – revealed that although low-dose aspirin was recommended in >85 percent of patients with a previous heart attack*, compliance remained sub-optimal. (1) Part of the problem appeared to be the lack of regular contact between physician and patient after a heart attack, which ranged from 45 percent in Latin-America to 65 percent in Europe and 72 percent in Asia-Pacific. However, seeing the doctor was not necessarily enough to ensure that patients who would benefit from low-dose aspirin therapy take the prescribed treatment.

“Even patients with good follow-up by their physician had sub-optimal compliance with aspirin therapy, which we attributed to insufficient discussion between patients and physician regarding the choice of low-dose aspirin therapy,” said Professor Augusto Zaninelli, a general practitioner in Italy and ACT study investigator. “Increasing the involvement of patients in the decision-making process is a key measure in improving compliance.” Patient non-compliance (i.e. total non-compliance or partial compliance) in the ACT study ranged from 29 percent in Europe to 35 percent in Latin-America and 37 percent in Asia-Pacific. (1,2)

With one of the lowest daily costs of any antiplatelet agent, cost is not a significant factor in non-compliance with aspirin. Professor Lieven Annemans, Professor of Health Economics and Pharmacoepidemiology at Ghent University, Belgium, highlighted recent economic analyses that have confirmed the cost-effectiveness of low-dose aspirin, even in people with a low annual risk of a cardiovascular (CV) event. (3–5) One of the analyses showed that low-dose aspirin resulted in average 10-year savings ranging from 201 Euros per patient in the UK to as high as 797 Euros per patient in Spain in patients with an annual risk of coronary heart disease (CHD) of 1.5 percent. (3) “Low-dose aspirin therapy becomes cost-saving even in patients with a low 10-year risk of fatal CVD,” added Prof. Annemans.

“These new data confirm the health economic benefits of low-dose aspirin, while emphasising the need for improved compliance among individuals who stand to benefit from its use” said Professor Thomas Pearson, University of Rochester School of Medicine, USA. “The broader appropriate use of aspirin could help prevent a significant number of heart attacks and strokes suffered worldwide each year. Low- dose aspirin is one drug that clearly should be recommended to patients at risk for heart disease and stroke on a global basis.”

CVD, in particular CHD and stroke, is responsible for one in three of all deaths worldwide, or approximately 17 million deaths a year, and the number of people at risk continues to increase. (6,7) The World Health Federation predicts that CVD mortality will increase to 24.2 million by 2030, and that 80 percent of this burden will occur in low-to middle-income countries such as Russia, Brazil and China. (8)  “Despite the availability of effective preventative measures such as aspirin, insufficient utilisation means that the global burden of CVD will continue to rise,” said Professor Shahryar Sheikh, past president of the World Health Federation. This will have a substantial impact on global economies, including both cost to healthcare systems and the loss of income and production by those with CVD and their caregivers.

In order to manage the growing burden of CVD and address underutilisation of aspirin, there is a need to address the gap between treatment guidelines and clinical practice. The benefit of low-dose aspirin for the prevention of CVD has been established by numerous studies in hundreds of thousands of patients, including the most recent meta-analysis from the Antithrombotic Trialists’ Collaboration (ATTC), which involved over 110,000 patients. (9) Based on this wealth of data, international guidelines recommend low-dose aspirin to reduce the risk of first and recurrent CV events. (10–15) Professor Pearson stressed the need for better education of patients on the benefits of aspirin, for increased awareness of the guideline recommendations among physicians to increase the use of low-dose aspirin in appropriate patients and reduce the burden of CVD, and improved systems of care to assure compliance with recommendations of national societies and other expert bodies.

As the use of aspirin broadens, new benefits of long-term aspirin therapy become apparent. Professor Carlo Patrono, Professor of Pharmacology at the Catholic University of Rome, Italy, commented that evidence is emerging to suggest a future role for low-dose aspirin in the prevention of certain cancers, particularly colorectal cancer. (16)

About AspirinCardio®
Aspirin, life-tested for generations, is one of the most extensively studied drugs in history, and boasts 110 years of clinical experience. More than 200,000 patients have been studied in more than 200 randomised clinical trials evaluating aspirin efficacy and safety across a broad range of CVD indications. AspirinCardio® is recognised as cornerstone therapy for reducing the risk of recurrent CVD events, including, but not limited to, heart attack and ischaemic stroke, based upon clinical studies and extensive clinical, real-world experience.

As with all drugs, aspirin is not for everyone. The determination of who is an appropriate candidate for aspirin therapy is a decision that must be made by both physician and patient. Patients should always talk with their physicians before starting or adjusting a low-dose aspirin regimen.

About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of healthcare, nutrition and high-tech materials. Bayer HealthCare, a subsidiary of Bayer AG, is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals divisions. The pharmaceuticals business operates under the name Bayer Schering Pharma. Bayer HealthCare’s aim is to discover and manufacture products that will improve human and animal health worldwide.

Find more information at www.bayerhealthcare.com.

Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company. Its research and business activities are focused on the following areas: Diagnostic Imaging, General Medicine, Specialty Medicine and Women's Healthcare. With innovative products, Bayer Schering Pharma aims for leading positions in specialized markets worldwide. Using new ideas, Bayer Schering Pharma aims to make a contribution to medical progress and strives to improve the quality of life.

Find more information at www.bayerscheringpharma.de. 

Forward-looking statements
This news release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

*Low-dose aspirin was recommended in the majority of patients in the ACT study; in the minority that was not recommended low-dose aspirin, this was due to side-effects, use of other medications or intolerability to aspirin.

References
(1) Zaninelli A, et al. Adherence to low-dose aspirin in secondary prevention: a comparison of European, Latin-American and Asia-Pacific countries. Abstract presented at the East Meets West Cardiology Congress 2009.
(2) Bayer Schering Pharma AG. Data on file.
(3) Lamotte M, Annemans L, Evers T, Kubin M. A multi-country economic evaluation of low-dose aspirin in the primary prevention of cardiovascular disease. Pharmacoeconomics 2006;24:155–69.
(4) Annemans L, Lamotte M, Kubin M, Evers T, Verheugt FW. Which patients should receive aspirin for primary prevention of cardiovascular disease? An economic evaluation. Int J Clin Pract 2006;60:1129–37.
(5) Tsutani K, Igarashi A, Fujikawa K, et al. A health economic evaluation of aspirin in the primary prevention of cardiovascular disease in Japan. Intern Med 2007;46:157–62.
(6) World Health Organization, Fact Sheet 317: Cardiovascular Diseases February 2007. Available at http://www.who.int/mediacentre/factsheets/fs317/en/index.html. Accessed 8 July 2009.
(7) World Health Organization, News Release 2004. WHO publishes definitive atlas on global heart disease and stroke epidemic. Available at http://www.who.int/mediacentre/news/releases/2004/pr68/en. Accessed 8 July 2009.
(8) World Health Organisation, The Atlas of Heart Disease and Stroke 2004. Available at www.who.int/cardiovascular_diseases/en/cvd_atlas_25_future.pdf. Accessed 8 July 2009.
(9) Baigent C, Blackwell L, Collins R, et al. Aspirin in the primary and secondary prevention of vascular disease: collaborative meta-analysis of individual participant data from randomised trials. Lancet 2009;373:1849–60.
(10) US Preventive Services Task Force. Aspirin for the prevention of cardiovascular disease. Recommendation statement. Available at: www.ahrq.gov/clinic/uspstf09/aspirincvd/aspcvdrs.htm. Accessed 8 July 2009.
(11) American Diabetes Association. Standards of medical care in diabetes - 2009. Diabetes Care 2009;32(Suppl 1):S13–S61.
(12) Becker RC, Meade TW, Berger PB, et al. On behalf of the American College of Chest Physicians. The primary and secondary prevention of coronary artery disease: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest 2008;133:776S–814S.
(13) Mosca L, Banka CL, Benjamin EJ, et al. Evidence-based guidelines for cardiovascular disease prevention in women: 2007 update. Circulation. 2007;115:1481–501.
(14) WHO: Prevention of Cardiovascular Disease. Pocket Guidelines for Assessment and Management of Cardiovascular Risk 2007. Available at: http://www.who.int/cardiovascular_diseases/guidelines/
PocketGL.ENGLISH.AFR-D-E.rev1.pdf. Accessed 8 July 2009.
(15) Graham I, Atar D, Borch-Johnsen K, et al. Fourth Joint Task force of the European Society of Cardiology and other societies on cardiovascular disease prevention in clinical practice. European guidelines on cardiovascular disease prevention in clinical practice: Executive summary. Eur Heart J 2007;28:2375–414.
(16) Flossmann E, Rothwell PM. Effect of aspirin on long-term risk of colorectal cancer: consistent evidence from randomised and observational studies. Lancet 2007;369:1603–13.