Backgrounder Aspirin Cardio - Press - Bayer

Background Information
Prevention of Heart Attack and Stroke
Addressing Blood Clot Formation — AspirinCardio ®
AspirinCardio ® ’s Unique Mode of Action
• Low‐dose aspirin (acetylsalicyclic acid), the active ingredient of AspirinCardio ® , belongs to a class
of drugs called antiplatelet agents.
• AspirinCardio ® contains a low dose of aspirin (usually 100 mg, although slightly lower doses of
75–100 mg are available in some countries).
• Platelet aggregation is a key mechanism in thrombus (blood clot) formation and the
development of cardiovascular (CV) events such as heart attack and stroke.
• Aspirin interferes with the activation of platelets through a unique mechanism of action
compared with other antiplatelet drugs by producing irreversible inhibition of an enzyme called
cyclo‐oxygenase 1 (COX‐1).
• By inhibiting COX‐1 in platelets, aspirin inhibits synthesis of a substance called thromboxane A2
(TXA2), a potent activator of platelet aggregation.
• The result is a sustained inhibition of platelet aggregation. By this mechanism, aspirin helps prevent
the precipitating event, i.e., a blood clot responsible for both ischaemic heart attacks and strokes.
Cardiovascular Benefits of Aspirin
• Although aspirin was originally recognized for its pain‐relieving and anti‐inflammatory
properties, research in recent decades has shown that low‐dose aspirin can be effective in the
prevention of certain CV events.
• The benefits of aspirin are evident across the continuum of CV risk, from the prevention of a first
CV event in patients with multiple risk factors to the prevention of recurrent events in patients
with established CV or cerebrovascular (blood vessels of the brain) disease.
• Low‐dose aspirin is currently approved in more than 50 countries for the prevention of a first CV
event*. It is also approved worldwide for the prevention of recurrent CV events.
Proven Benefit in Cardiovascular Disease
• Low‐dose aspirin continues to be recognised as a life‐saving therapy and is the standard of care
for reducing the risk of heart attacks and strokes in people with established cardiovascular
disease (CVD) (secondary prevention).
• The broader use of low‐dose aspirin in appropriate patients may help prevent many thousands
of initial CV events worldwide and save substantial financial resources in both direct and indirect
healthcare costs. 1
* Bayer supports the use of low‐dose aspirin for primary prevention only in those countries where the
indication has been approved. Only a physician can determine whether a patient is at sufficient risk
of a cardiovascular event to warrant daily aspirin therapy.

• A recent meta‐analysis of the role of aspirin in the prevention of CVD, performed by the
Antithrombotic Trialists’ Collaboration (ATTC), has reaffirmed the effectiveness of low‐dose
aspirin in preventing recurrent CV events. 2
• This evaluation, which included 16 secondary prevention trials involving approximately 17,000
patients with previous CV events (e.g. heart attack, stroke or ‘mini‐stroke’ also called a transient
ischaemic attack), showed that aspirin therapy is associated with a statistically significant
reduction of recurrent CV events including:
- 19% reduction in serious vascular events such as heart attacks, stroke or death from vascular
causes
- 20% reduction in major coronary events, such as heart attacks
- 31% decrease in non‐fatal heart attacks
- 13% reduction in heart‐related deaths
- 22% decrease in stroke caused by thrombosis
• Aspirin is also effective in reducing the risk of a first CV event in a range of subjects, as
demonstrated in six landmark trials involving more than 95,000 individuals. 3,4,5,6,7,8
• The ATTC meta‐analysis i included individual patient data from these six trials and reaffirmed
that aspirin therapy is associated with a statistically significant reduction of CV events in people
without CVD. Results demonstrated:
- 12% reduction in serious vascular events
- 18% reduction in major coronary events, such as heart attacks
- 23% reduction in non‐fatal heart attacks
- 14% reduction in stroke due to thrombosis
- A greater that 2:1 benefit risk ratio on the primary prevention setting
Potentially Substantial Reduction in CV Events
• Numerous, multidisciplinary international consensus guidelines recommend low‐dose aspirin for
the prevention of first and recurrent CV events in at‐risk individuals. 9,10,11,12,13,14,15 *
• In spite of the widely known benefits of low‐dose aspirin therapy, it is thought to be widely
underused in individuals who could benefit from it, even in people who are at high risk of
developing CVD. 16,17,18,19
- Results from the Aspirin Underutilisation and Compliance in CVD Treatment (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 more than 85% of patients with a previous heart attack, compliance
remained sub‐optimal.
- Compliance among patients in Europe who have previously suffered heart attacks was only
29%, meaning that a large proportion of patients were not fully compliant in taking their life‐
saving medicines regularly. 20
* Bayer supports the use of low‐dose aspirin for primary prevention only in those countries where the
indication has been approved. Only a physician can determine whether a patient is at sufficient risk
of a cardiovascular event to warrant daily aspirin therapy.
2

Well‐Established Safety Profile
• Aspirin is one of the most extensively studied drugs in history, with a 110‐year history of clinical
use.
• While the most common side effects associated with aspirin use are GI related, the majority of
them are minor and resolve without medical intervention. More serious effects, such as
significant bleeding, are rare. (see Safety backgrounder for additional information)
References
1 Ford ES, Giles WH, Mokdad AH. The distribution of 10‐year risk for coronary heart disease among US adults: findings from
the National Health and Nutrition Examination Survey III. J Am Coll Cardiol 2004;43:1791–6.
2 Antithrombotic Trialists’ Collaboration. Aspirin in the primary and secondary prevention of vascular disease: collaborative
meta‐analysis of indivdual participant data from randomised trials. Lancet 2009;373:1849–60.
3 Peto R, Gray R, Collins R, et al. Randomised trial of prophylactic daily aspirin in British male doctors. Br Med J (Clin Res Ed)
1988;296:313–6.
4 Steering Committee of the Physicians' Health Study Research Group. Final report on the aspirin component of the
ongoing Physicians' Health Study. N Engl J Med 1989;321:129–35.
5 Thrombosis prevention trial: randomised trial of low‐intensity oral anticoagulation with warfarin and low‐dose aspirin in
the primary prevention of ischaemic heart disease in men at increased risk. The Medical Research Council's General
Practice Research Framework. Lancet 1998;351:233–41.
6 Hansson L, Zanchetti A, Carruthers SG, et al. Effects of intensive blood‐pressure lowering and low‐dose aspirin in patients
with hypertension: principal results of the Hypertension Optimal Treatment (HOT) randomised trial. HOT Study Group.
Lancet 1998;351:1755–62.
7 de Gaetano G; Collaborative Group of the Primary Prevention Project. Low‐dose aspirin and vitamin E in people at
cardiovascular risk: a randomised trial in general practice. Lancet 2001;357:89–95.
8 Ridker PM, Cook NR, Lee IM, et al. A randomized trial of low‐dose aspirin in the primary prevention of cardiovascular
disease in women. N Engl J Med 2005;352:1293–304.
9 American College of Chest Physicians. Antithrombotic and thrombolytic therapy: 8th edition. Primary and secondary
prevention of coronary artery disease. Chest 2008; 133:776S–814S.
10 Mosca L, Banka CL, Benjamin EJ et al for expert panel/writing group. AHA Guideline. Evidence‐based guidelines for
cardiovascular disease prevention in women: 2007 update. Circulation. 2007;115:1481‐501.
11 WHO: Prevention of Cardiovascular Disease. Pocket Guidelines for Assessment and Management of Cardiovascular Risk
2007.
12 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: European guidelines on
cardiovascular disease prevention in clinical practice: Executive summary. Eur Heart J 2007; 28:2375–414.
13 American Diabetes Association. Standards of medical Care in Diabetes–2009. Position Statement. Diabetes Care
2009;32:S13–61.
14 The Task Force on Diabetes and Cardiovascular Diseases of the European Society of Cardiology (ESC) and of the European
Association for the Study of Diabetes (EASD) ESC/EASD Task Force. Guidelines on diabetes, pre‐diabetes, and
cardiovascular diseases: executive summary. Eur Heart J 2007;28:88–136.
15 The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood
Pressure. Hypertension. 2003;42:1206.
16 Bayer HealthCare LLC, Consumer Care Division, 2006 Global Cardio Market Study
17 Stafford RS, Monti V, Ma J. Underutilization of Aspirin Persists in US Ambulatory Care for the Secondary and Primary
Prevention of Cardiovascular Disease. PLoS Med 2005;2: e353.
18 Stafford R, Ma J. Continued suboptimal use of Aspirin in patients at high and moderate risk for CHD events. Presented at
the Society of General Internal Medicine Annual Meeting, Chicago, Ill., May 12‐15, 2004 (Abstract).
19 Bayer Aspirin/American College of Preventive Medicine market research survey. Conducted by Harris Interactive, January
2005.
20 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.
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