Aspirin in The Primary Prevention of Cardiovascular Disease and Cancer

6/7/2017 Aspirin in the primary prevention of cardiovascular disease and cancer - UpToDate
Official reprint from UpToDate

www.uptodate.com 2017 UpToDate
Aspirin in the primary prevention of cardiovascular disease and cancer
Authors: Frederick A Spencer, MD, Gordon Guyatt, MD, Charles H Hennekens, MD, DrPH
Section Editors: Joann G Elmore, MD, MPH, Christopher P Cannon, MD
Deputy Editor: Gordon M Saperia, MD, FACC
All topics are updated as new evidence becomes available and our peer review process is complete.
Literature review current through: Jun 2017. | This topic last updated: Dec 19, 2016.
INTRODUCTION Cardiovascular disease (CVD) and cancer are the leading causes of morbidity and
mortality worldwide, representing 24 and 13 percent of all deaths, respectively [1,2]. Aspirin produces
statistically significant and important reductions in CVD morbidity and mortality among survivors of a wide
range of occlusive CVD events, including subsequent coronary heart disease, especially myocardial
infarction, stroke, and CVD death. In secondary prevention, the absolute benefits on occlusive events are far
greater than the absolute risks of major bleeding. In primary prevention, however, among apparently healthy
people, the benefit-to-risk ratio is less clear due, at least in part, to the paucity of randomized evidence
among the moderate- to high-risk subjects most likely to achieve a net benefit.
While the benefits of aspirin on CVD have been known for decades, more randomized evidence has
suggested a benefit on colorectal cancer and possibly total cancer deaths as well as on the development of
other cancers. These findings may impact the threshold for the prescription of aspirin by health care
professionals and the wishes of primary prevention subjects.
This topic summarizes the evidence regarding the benefits and risks of aspirin for primary prevention of CVD
and cancer. We believe the utilization of aspirin, as for any over-the-counter drug used long term, should be
an individual clinical and shared decision between the health care professional and each of his or her
patients that carefully weighs all the absolute benefits against all the absolute risks [3-5].
Discussion of the role of aspirin in secondary prevention of CVD is presented separately. The role of
nonsteroidal anti-inflammatory drugs and aspirin in the prevention of colorectal cancer (exclusive of CVD) is
discussed separately as well. (See "NSAIDs (including aspirin): Role in prevention of colorectal cancer" and
"Aspirin for the secondary prevention of atherosclerotic cardiovascular disease".)
MECHANISMS OF ACTION
Cardiovascular disease Aspirin at all clinically relevant doses produces a clinically relevant antiplatelet
effect by irreversibly acetylating the active site of cyclooxygenase-1 (COX-1), which is required for the
production of thromboxane A2, a powerful promoter of aggregation. These findings are achieved by daily
doses of 75 mg (and higher) or perhaps doses as low as 30 mg. Higher doses of aspirin also inhibit COX-2,
which blocks prostaglandin production leading to analgesic and antipyretic effects. Although other
mechanisms have been proposed (eg, an antiinflammatory effect), the antiplatelet effect seems sufficient to
explain the observed statistically significant and clinically important benefits of aspirin on CVD. (See "Aspirin:
Mechanism of action, major toxicities, and use in rheumatic diseases" and "Platelet biology" and "The role of
the vulnerable plaque in acute coronary syndromes".)
Cancer Plausible biological mechanisms for anticancer effects of aspirin include induction of cell apoptosis
as well as inhibition of cyclooxygenase-catalyzed prostaglandin production. In colorectal cancer, aspirin may
also influence the PIK3CA pathway [6]. Prostaglandins are associated with tumor angiogenesis, cell
proliferation, and inhibition of immune surveillance and apoptosis [7]. (See "The role of platelets in coronary
heart disease" and "NSAIDs (including aspirin): Role in prevention of colorectal cancer".)
https://www.uptodate.com/contents/aspirin-in-the-primary-prevention-of-cardiovascular-disease-and-cancer/print?source=see_link 1/16
POTENTIAL BENEFITS Use of aspirin for at least 10 years for primary prevention decreases the risk of
myocardial infarction (MI) and possibly all-cause mortality. Longer use is associated with a reduced risk of
colorectal cancer.
Prevention of CVD events Numerous randomized trials (and their meta-analyses) have tested whether
aspirin reduces risks of cardiovascular disease (CVD) in apparently healthy men and women.
In 2016, a comprehensive meta-analysis of 11 trials that included individual patient level data among over
118,445 men and women who were randomly assigned to either aspirin (at doses between 50 and 500 mg
per day) or placebo reported the following outcomes [8]:
A significant 22 percent reduction in nonfatal MI (relative risk [RR] 0.78, 95% CI 0.71-0.87).
A significant 6 percent reduction in all-cause mortality (RR 0.94, 95% CI 0.89-0.99).
No significant benefit on nonfatal stroke (RR 0.95, 95% CI 0.85-1.06).
Other meta-analyses have shown similar results [9-15].
Prevention of cancer Long-term follow-up data from the numerous trials of aspirin in the treatment and
prevention of CVD have provided an opportunity to explore possible benefits on cancer incidence and
mortality.
Colorectal cancer Aspirin and other nonsteroidal antiinflammatory drugs (NSAIDs) inhibit colorectal
carcinogenesis, metastases, and related mortality. (See "NSAIDs (including aspirin): Role in prevention of
colorectal cancer".)
Randomized evidence indicates that aspirin decreases colorectal cancer incidence but this finding begins to
emerge only after 10 years of follow-up. The United States Preventive Services Task Force (USPSTF)
conducted a meta-analysis of four randomized controlled trials (RCTs) [16-19] and reported no effect of
aspirin on colorectal cancer incidence over a follow-up spanning 0 to 12 years (RR 0.99, 95% CI 0.85-1.15)
[20]. Data were available for longer-term post-treatment follow-up for three of these studies (British Medical
Doctor study [19], Women's Health Study [21], United Kingdom TIA study [18]). The meta-analyses showed
that, after long-term follow up, aspirin significantly decreases colorectal cancer by 40 percent (RR 0.60, 95%
CI 0.47-0.76).
Additional randomized evidence comes from a systematic review of four RCTs comparing aspirin with
placebo conducted in Sweden or Great Britain; the median treatment duration ranged from 2.6 to 6.9 years
[19,22-25]. The investigators performed additional follow-up using national death and cancer registries (and
in one study patient/physician contact) for 14,033 patients over a median follow-up of 18.3 years.
Aspirin reduced by 24 percent the 20-year risk of colon cancer (incidence hazard ratio [HR] 0.76, 95% CI
0.60-0.96).
This benefit increased with increased duration of treatment such that 2.5 or more years of aspirin was
associated with a significant reduction of 31 percent (HR 0.69 [95% CI 0.51-0.93]) and five or more years
with a significant reduction of 38 percent (HR 0.62 [95% CI 0.43-0.94]).
Subgroup analyses of site-specific cancer showed that aspirin significantly reduced the risk of proximal
colon cancer by 55 percent (HR 0.45, 95% CI 0.28-0.74) but not distal colon cancer (HR 1.10, 95% CI
0.73-1.64).
Further indirect evidence derived from randomized trials shows that aspirin reduces adenomatous polyps of
the colon [26-29].
In the aforementioned systematic review, utilizing long-term follow-up data from four RCTs, aspirin was
associated with a 34 percent reduced long-term risk of colorectal cancer mortality (HR 0.66, 95% CI 0.51-
0.85) [22].
A subsequent meta-analysis published in 2011 reported data from randomized trials comparing aspirin with
no aspirin (trials of patients without [and with] established vascular disease) [30]. Individual patient data
(23,535 patients) were available from seven of the eight trials.
Aspirin was associated with a possible but nonsignificant 22 percent reduction in colorectal cancer
during 0 to 5 years follow-up (HR 0.78, 0.39-1.56), but there was a 59 percent reduction of borderline
significance for follow-up of 5 years (HR 0.41, 0.17-1.00).
Three of the trials conducted in the United Kingdom continued to collect mortality data up to 20 years. In
these trials, aspirin was associated with a significant 40 percent reduction in risk of death from colorectal
cancer over this period (HR 0.60, 95% CI 0.45-0.81). In the first 10 years of follow-up, there was a
possible but nonsignificant 21 percent reduction (HR 0.79, RR 0.49-1.26), but a significant reduction was
found from 10 to 20 years (HR 0.51, 95% CI 0.35-0.74).
A more detailed review of aspirin and other NSAIDs on reducing risk of colorectal adenomas and cancer,
depending on dose and duration of therapy, is discussed elsewhere. (See "NSAIDs (including aspirin): Role
in prevention of colorectal cancer".)
Other cancers For noncolorectal cancers, the data regarding a beneficial effect on incidence and
either cancer-specific or overall cancer mortality are less robust and less consistent [31-33]. Any reduction in
cancer mortality may relate both to cancer prevention as well as to a decrease in the risk of cancer
metastasis [34]. The effect of aspirin on cancer mortality is likely to require a longer duration to detect reliably
than on cancer incidence.
A meta-analysis of individual patient-level data from six primary prevention trials suggests the following [32]:
Daily aspirin use was associated with a significant reduction of 12 percent in the incidence of all cancers
during follow-up (HR 0.88, 95% CI 0.80-0.98).
The benefit became apparent at four years of follow-up and was independent of age, gender, and
smoking status.
The benefit after four years increased thereafter. In analysis of longer durations of five years or greater
after starting, aspirin was associated with a significant 30 percent reduction in all cancers. (HR 0.70
[95% CI 0.56-0.88]).
After combining the data from the six primary prevention trials with 21 secondary prevention trials for
which the site of fatal cancer was known, aspirin was associated with a significant reduction in the
subgroups of nonfatal and fatal cancers of the female reproductive tract, lymphoma, and sarcoma. The
number of cases was too small to adequately assess any possible associations between aspirin and
cancer at other sites.
In a meta-analysis of 51 RCTs, data on cancer-related mortality were available from 34 (n = 69,224) [32]. In
these trials, 58 percent of nonvascular deaths were due to cancer. The following findings were noted:
Aspirin was associated with a significant reduction in overall cancer-related mortality of 15 percent (OR
0.85, 95% CI 0.76-0.96).
Although the numbers of cancer deaths by subgroup were small, aspirin was associated with a
significant reduction in mortality of 42 percent in colorectal (OR 0.58, 95% CI 0.38-0.89) and a possible
borderline significant reduction of 48 percent in lymphoma (OR 0.52, 95% CI 0.26-1.00).
When stratified by follow-up duration (<3 years, 3 to 4.9 years, 5 years), only patients followed for >5
years demonstrated a significant benefit of aspirin on cancer mortality of 37 percent (OR 0.63, 95% CI
0.49-0.82).
Aspirin was also associated with a significant decrease in nonvascular mortality, including cancer-related
mortality of 12 percent (OR 0.88, 95% CI 0.78-0.96).
In the 12 trials of primary prevention (n = 44,068), aspirin was associated with a significant decrease in
the risk of nonvascular death of 12 percent (OR 0.88, 95% CI 0.78-0.98) [32]. One limitation of this
analysis is exclusion of two primary prevention studies utilizing every-other-day aspirin. In the
Physician's Health Study and in the Women's Health Study, which compared aspirin every other day
(with different aspirin doses in the two trials) with control, there was no significant difference in
nonvascular mortality [16,17,21]. The stated rationale for exclusion is a postulated difference in effect
associated with alternate day dosage.
A limitation of this meta-analysis was the exclusion of data from the Women's Health study [17] that
evaluated the impact of every-other-day dosing of aspirin. The Women's Health Study, which included almost
40,000 women followed approximately 10 years, found no effect of every-other-day, low-dose aspirin on total
cancer incidence even after further follow-up in a subset of patients to 18 years (HR 0.97, 95% CI 0.92-1.03)
[21]. The authors of the meta-analysis suggest this exclusion was based on observational data suggesting
that daily aspirin use may be required for antineoplastic effects. It is important to note that the observational
data are inconsistent, and the rationale for exclusion of this large randomized trial of long duration is unclear.
The USPSTF conducted analyses that included data from six primary prevention trials of aspirin deemed of
fair or good quality, including the alternate day dosing Women's Health Trial [33]. They did not include two of
the studies included in a large, independent patient-level data analysis discussed directly above [32]. The
USPSTF analysis (mean duration 3.6 to 10.1 years) showed:
Cancer incidence was not significantly reduced with long-term aspirin (RR 0.98, 95% CI 0.93-1.04).
Addition of data from four RCTs among secondary CVD populations did not change these findings.
A significant decrease in cancer incidence was present only when the analysis was limited to trials of
daily aspirin (including for both primary and secondary prevention) with median intended duration of >4
years.
In a meta-analysis of nine RCTs comparing aspirin with placebo for primary prevention (that included the
Women's Health Study and Physician's Health Study which used alternate day dosing), aspirin was not
associated with a significant reduction in cancer mortality (OR 0.93, 95% RR 0.84-1.03) [9]. Aspirin was
associated with a possible reduction of borderline significance of 8 percent in total nonvascular mortality (OR
0.92, 95% CI 0.85-1.00).
In a meta-analysis of eight RCTs, the role of aspirin on overall and other site-specific cancer deaths was
evaluated [30]:
In eight eligible trials (25,570 patients), aspirin was associated with a significant reduction in cancer
death of 21 percent (OR 0.79, 95% CI 0.68-0.92).
Individual patient data (23,535 patients) were available from seven of the eight trials and showed a
significant reduction in cancer deaths of 34 percent only after five years of follow-up (HR 0.66, 95% CI
0.50-0.87).
Three of the trials collected mortality data up to 20 years. The 20-year risk of death from solid cancers
was a significant 20 percent reduction (HR 0.80, 95% CI 0.72-0.88). The magnitude of this benefit
increased with increasing duration of aspirin treatment
Reducing mortality The effect of aspirin on all-cause mortality in trials of primary prevention of CVD has
been evaluated in three separate meta-analyses [8,9,14]. Each has suggested a reduction in all-cause
mortality with aspirin. In the USPSTF review discussed above (see 'Prevention of CVD events' above),
aspirin was associated with a small but significant 6 percent decrease in overall mortality (RR 0.94, 95% CI
0.89-0.99 [8]).
A larger meta-analysis of 51 randomized trials that included both primary and secondary prevention patients
also suggested a possible reduction in total mortality of 8 percent of borderline significance (OR 0.92, 95% CI
0.85-1.00) [32]. The width of the 95% confidence interval indicates that the magnitude of the reduction is
likely to be as large as 15 percent or as small as no effect.
These benefits are largely driven by a reduction in noncardiovascular mortality. Because the confidence
interval is close to or in some cases includes 1 (no difference between treatments) some might conclude
aspirin has no effect. A more appropriate interpretation would focus on the point estimate (an approximate 6
percent relative risk reduction) acknowledging that the confidence interval is wide enough to leave us only
moderately confident of the small mortality reduction with aspirin.
A meta-analysis of the use of aspirin for the primary prevention of CVD and cancer performed for the United
Kingdom Health Technology Assessment group found a similar estimate for the impact of aspirin on total
mortality [35].
Summary of benefits Data from individual randomized trials and their meta-analyses suggest that aspirin
is associated with:
A significant reduction of 22 percent in non-fatal MI over 10 years.
No significant reduction on nonfatal stroke (combining ischemic stroke, for which a benefit is postulated
and hemorrhagic stroke, for which a risk is postulated) over 10 years.
A significant reduction of 24 percent in colon cancer incidence over long-term follow-up (20 years).
A significant reduction of 35 percent in colorectal cancer mortality over long-term follow-up (20 years).
A possible reduction of 6 to 8 percent in overall mortality over 10 years.
The quality of evidence is high for MI and bleeding (see 'Bleeding' below), moderate for mortality and stroke,
and lower for colorectal incidence and mortality.
The American College of Chest Physicians Antithrombotic Therapy and Prevention of Guidelines, 9th edition
(AT9) estimated the absolute risks and benefits associated with aspirin in primary prevention over a time
frame of a decade for the outcomes of total mortality, non-fatal MI, non-fatal stroke (including hemorrhagic),
and major extracranial bleeding [36]. The table presented in AT9 has been modified, incorporating data
relative to the incidence of colorectal cancer (table 1).
ADVERSE EFFECTS
Bleeding The primary adverse effect of aspirin is major bleeding, typically defined as bleeding from the
gastrointestinal (GI) tract or other sites that requires hospitalization and/or transfusion, as well as the
extremely rare but catastrophic intracranial bleeding. Aspirin confers a significant 50 percent increase in
major nonfatal extracranial bleeding over 10 years.
Bleeding most commonly occurs in the GI tract and is rarely fatal. Bleeding also occurs at other sites, with
intracranial bleeding (hemorrhage) being the most rare (approximately 4 per 10,000) but the most serious
(with a 50 percent case fatality ratio). In most patients who have an episode of major bleeding while taking
aspirin for primary prevention, a decision must be made about whether the risk of recurrent bleeding
outweighs the benefits of long-term use.
The risks of major bleeding in meta-analyses of randomized trials comparing aspirin with placebo are as
follows:
In a 2016 meta-analysis, low-dose aspirin use (100 mg daily) was associated with a significantly
increased risk of major GI bleeding of 58 percent (odds ratio [OR] 1.58, 95% CI 1.29-1.95) [37]. This risk
was somewhat higher when all doses of aspirin were considered.
In the 2016 meta-analysis, low-dose aspirin was associated with a possible but nonsignificant increase in
hemorrhagic stroke of 27 percent (OR 1.27, 95% CI 0.96-1.68).
In the individual patient data meta-analysis of six primary prevention trials, aspirin was associated with a
significant 54 percent increased risk of major bleeding (GI and other extracranial) compared with patients
not taking aspirin (RR 1.54, 95% 1.30-1.82) [10]. The excess risk was in nonfatal bleeds; there were
actually fewer fatal bleeds among aspirin users than nonaspirin users (although event rates were very
low for both).
The incidence of major bleeding is likely to be higher in the general population than among participants in
randomized trials. In general, randomized trials did not include individuals who were felt to be at increased
risk for bleeding complications.
The absolute bleeding risks are presented in a table (table 1).
The United States Preventive Services Task Force report on the use of aspirin for the primary prevention of
cardiovascular disease (CVD) and cancer suggested that increasing age, male sex, and diabetes increased
the risk for major bleeding [37]. (See "NSAIDs (including aspirin): Primary prevention of gastroduodenal
toxicity" and "NSAIDs (including aspirin): Primary prevention of gastroduodenal toxicity", section on 'Risk
factors'.)
Issues related to the primary prevention of GI toxicity from nonsteroidal antiinflammatory drugs (NSAIDs) are
discussed in detail elsewhere. (See "NSAIDs (including aspirin): Primary prevention of gastroduodenal
toxicity", section on 'Prevention strategies'.)
Aspirin sensitivity A very small minority of patients are unable to tolerate aspirin because of
hypersensitivity, which is most often manifested clinically as respiratory symptoms, including rhinitis and/or
asthma, and less frequently as urticaria/angioedema (7 to 20 per 10,000 treated) [38-40]. With some forms of
aspirin sensitivity, cross-reactions occur with other NSAIDs. (See "NSAIDs (including aspirin): Allergic and
pseudoallergic reactions".)
In such circumstances, clopidogrel may be a suitable alternative. Desensitization to aspirin may be another
option. (See "Aspirin-exacerbated respiratory disease: NSAID challenge and desensitization", section on
'Desensitization'.)
DOSING The potential benefits on cardiovascular disease (CVD) events from long-term aspirin therapy
are achieved with doses in the range of 75 to 100 mg daily but the data for cancer benefit are not entirely
consistent.
Prevention of CVD events Aspirin in doses from 75 to 325 mg daily produce similar benefits on CVD
events to doses in excess of 1300 mg but with far fewer side effects. In direct comparisons from three
randomized trials, there were no significant differences in side effects between 75 and 325 mg.
The subgroup analyses from the Antithrombotic Trialists Collaboration meta-analyses provide [41] direct and
indirect comparisons of different daily doses of aspirin (500 to 1500 mg versus 160 to 325 mg versus 75 to
160 mg versus <75 mg) in patients with preexisting vascular disease at high risk for future events. In these
analyses, aspirin appears to be equally effective for the prevention of vascular events at doses between 75
and 325 mg per day.
Prevention of cancer events Most observational cohort studies suggest a preventive effect on
development of adenomas and/or colorectal cancer that increases with increasing number of aspirin doses
per week [42,43]. (See "NSAIDs (including aspirin): Role in prevention of colorectal cancer", section on
'Aspirin trials'.)
These observational data are consistent with some, but not all, randomized data that daily, as opposed to
every second day, aspirin is required for prevention of colorectal and possibly other cancers [18].
Bleeding Available evidence suggests that, for primary prevention, aspirin doses of 100 mg per day
should be used to minimize risk of bleeding. In indirect comparisons in the meta-analysis conducted by the
Antithrombotic Trialists' Collaboration, there were no significant differences in risk of major extracranial
bleeding across dose of aspirin from 75 to 325 mg/day [41]. In contrast, a number of observational studies,
which are prone to confounding by indication, have suggested a potential relationship between increased
aspirin doses and bleeding. In a systematic review of >190,000 patients enrolled in 31 studies, aspirin
dosage greater than 200 mg per day was associated with an approximate 30 percent increase in major
bleeding compared with lower doses [44]. The investigators also reported an increase in nonmajor bleeding
in patients receiving 100 to 200 mg of aspirin per day compared with patients taking less than 100 mg per
day.
ASSESSING BENEFITS AND RISKS The decision regarding aspirin for primary prevention should be
individualized based on the benefits and risks. Practitioners and patients should have frank and open
discussions and these discussions should include patient values and preferences regarding cardiovascular
disease (CVD), colorectal cancer, and major bleeding.
[45].
Numerous tools are available to estimate benefits and risks. However, none of these provides a risk-to-
benefit calculation that takes into account all the risk factors for CVD events or the combined risk of
cardiovascular events, and colon cancer, and risk of major bleeding with daily use. In addition, many
calculators may not include major risk factors such as family history of early CVD or cancer as well as obesity
or physical inactivity [46]. (See "Estimation of cardiovascular risk in an individual patient without known
cardiovascular disease".)
The anticipated absolute effects of taking low-dose aspirin for 10 years compared with no aspirin in the
primary prevention of cardiovascular disease and cancer is shown for populations at different levels of risk for
cardiovascular disease and different risk levels for cancer (table 1). Patients without prior cardiovascular
disease or cancer will fall into one of three broad groups:
Low-risk individuals Consider aspirin use for 10 years in 1000 patients at age 40 with low
Framingham risk score (estimated 10-year cardiovascular risk of 2.7 percent) and low risk of colorectal
cancer (3 percent), one could expect five fewer myocardial infarctions (MIs), four more major bleeds, and
seven fewer colorectal cancers with aspirin use. Our judgment is that for most patients the absolute
benefits of daily aspirin in low risk subjects are insufficient to warrant use of long-term daily aspirin.
Intermediate-risk individuals A different benefit to risk emerges for patients at somewhat higher risk of
CVD and malignancy: 1000 patients at age 60 years and a risk of CVD events of 10 to 20 percent over
10 years and at average risk of any malignancy (approximately 12 percent). Aspirin use over a 10-year
period would be expected to result in six few deaths (table 1), 17 fewer MIs, 16 more major extracranial
bleeding events, and 13 fewer cases of colorectal cancer over 20-year follow-up. Individual patient
values and preferences should play significantly into decision making in this group. (See 'Individualizing
decisions' below.)
High-risk individuals Some patients are at particularly high risk of cardiovascular disease, such as
those whose 10-year risks of a first CHD event are 16 to 18 percent. These are typically individuals over
the age of 40 years who have multiple CVD risk factors. This group includes individuals who are most
likely to benefit from long-term daily aspirin.
Individualizing decisions After assessing the potential benefits and risks as discussed above, clinicians
should discuss the anticipated effects on each individual outcome as well as the net benefit with the patient.
Individual patients will place different values on each outcome, particularly when considering a long-term
therapy with low absolute benefit and risk. Some may determine that the absolute net benefit of aspirin
therapy is not of sufficient magnitude to warrant the inconvenience of long-term medication use.
Factors to be considered in this discussion include the following:
Recommendations may differ depending on the degree of cardiovascular risk, with more potential
cardiovascular benefit of aspirin in patients at greater cardiovascular risk. It is very likely, however, that
bleeding risk also increases with increasing cardiac risk, limiting the gradient in net benefit across
cardiovascular risk.
Use of concomitant medications known to increase bleeding risk associated with aspirin (anticoagulants,
NSAIDs) will reduce the net benefit associated with aspirin use.
Individualized clinical assessment of patient risk for colorectal malignancy based on family history and
prior medical history (eg, colonic polyps) should be considered. (See "Screening for colorectal cancer:
Strategies in patients at average risk" and "Screening for colorectal cancer in patients with a family
history of colorectal cancer".) Calculators for estimated risk of colorectal cancer (eg, NCI Colorectal
Cancer Risk Predictor Tool) may help in making this determination. Such a history may increase the
possible absolute benefit of aspirin use.
Assessing the value a patient places on preventing a specific outcome relative to others is important. For
example, patients may place greater value on avoiding vascular events or colon cancer versus
increasing risk of bleeding.
OUR APPROACH The decision to prescribe aspirin should be made on an individual (patient-by-patient)
basis through a process of shared decision making by the patient and health care provider after assessment
of the benefit-to-risk profile of the patient. For patients who receive aspirin for primary prevention, we
recommend a dose of 75 to 100 mg daily. Some experts may prescribe higher daily doses for prevention of
colorectal cancer.
Many tools are available to calculate the risk of a cardiovascular event. None of these provides a risk-to-
benefit calculation that takes into account risk of cardiovascular events, risk of the development of colonic
cancer, and risk of major bleeding with daily aspirin. We sometimes use one of these to help patients in
decision making (calculator 1 and calculator 2 and calculator 3 and calculator 4) [47]. These tools are
discussed separately. (See "Estimation of cardiovascular risk in an individual patient without known
cardiovascular disease".)
For all patients, whether low or high risk, the absolute benefit on myocardial infarction approximated the
absolute increase in the risk of major bleeding. Most patients will also want to consider the potential but small
benefits on development of colorectal cancer and on total mortality. Whatever the level of cardiovascular risk,
patients considering primary prophylaxis may reasonably choose to use or not use aspirin.
Many individuals age 50 years or greater without excess bleeding risks are likely to conclude that the benefits
of aspirin at a dose of 75 to 100 mg per day for the prevention of cardiovascular disease events, colorectal
cancer incidence, and overall mortality outweigh the risks [48].
RECOMMENDATIONS OF OTHERS Recommendations regarding the daily use of low-dose aspirin vary
from guideline to guideline. The following represent recommendations from societal guideline organizations:
The 2016 United States Preventive Services Task Force statement on the use of aspirin for the
prevention of cardiovascular disease (CVD) and colorectal cancer makes recommendations for adults
aged 40 years or older without known CVD and without increase bleeding risk [49,50]:
Low-dose aspirin is recommended for individuals aged 50 to 59 years of age who have a 10 percent
or greater 10-year risk of CVD risk, who are not at increased risk for bleeding, who have a life
expectancy of 10 years, and who are willing to take aspirin for 10 years. Risk was calculated using
the American College of Cardiology/American Heart Association cardiovascular risk calculator
[46,51].
The evidence to recommend aspirin in a population aged 60 to 69 years is less robust and the
decision should be individualized.
In adults younger than 50 or older than 70 years, the evidence is insufficient to make a
recommendation.
2012 guidelines from the American College of Chest Physicians (ACCP) suggest the use of low-dose
aspirin (75 to 100 mg daily) for persons age 50 years or older without symptomatic CVD [36]. This is the
only guideline to discuss the potential impact of aspirin on cancer incidence and mortality and include
data on the potential impact of aspirin on total mortality when considering recommendations. The
guidelines note that benefits are small, and a substantial proportion of people will likely decline aspirin for
primary prophylaxis. The ACCP guidelines also recommend against the use of aspirin or other platelet
agents in patients who are managed on anticoagulant therapy [52].
2012 guidelines from the European Society of Cardiology, which did not consider cancer risk, advise
against the use of aspirin or clopidogrel in individuals without cardiovascular or cerebrovascular disease
due to the risk of major bleeding [53].
INFORMATION FOR PATIENTS UpToDate offers two types of patient education materials, "The Basics"
and "Beyond the Basics." The Basics patient education pieces are written in plain language, at the 5th to 6th
grade reading level, and they answer the four or five key questions a patient might have about a given
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in-depth information and are comfortable with some medical jargon.
Here are the patient education articles that are relevant to this topic. We encourage you to print or e-mail
these topics to your patients. (You can also locate patient education articles on a variety of subjects by
searching on "patient info" and the keyword(s) of interest.)
Beyond the Basics topic (see "Patient education: Aspirin in the primary prevention of cardiovascular
disease and cancer (Beyond the Basics)")
SUMMARY AND RECOMMENDATIONS
In patients without prior cardiovascular disease events, aspirin decreases the risk of nonfatal myocardial
infarction and likely results in small decreases in overall mortality but increases the risk of major
bleeding. Aspirin possibly reduces the risk of colorectal cancer over long-term follow-up (with >10 years
of treatment). (See 'Prevention of CVD events' above and 'Prevention of cancer' above and 'Reducing
mortality' above and 'Bleeding' above.)
Estimates of the very small absolute benefits and risks of aspirin in primary prevention are provided in a
table (table 1). Clinicians can use these estimates as a starting point for discussions with individual
patients. Not all informed patients will choose to use aspirin and individual discussion is imperative. (See
'Assessing benefits and risks' above.)
Factors to be considered in this discussion include assessment of the individual's risk for each outcome
(cardiovascular events, colorectal cancer, bleeding, and total mortality); assessment of the relative value
the individual places on preventing specific outcomes; assessment of the patient's attitude to
inconvenience of long-term daily therapy; and value placed on immediate increase in risk of bleeding
versus delayed potential benefit on death. (See 'Individualizing decisions' above.)
In many adults, the benefits of aspirin exceed the risks (principally bleeding). For individuals age 50
years without excess bleeding risk, we suggest low-dose daily aspirin (75 to 100 mg) (Grade 2B).
Patients who are more concerned about the bleeding risks than the potential benefits may reasonably
choose to not take aspirin for primary prevention. (See 'Assessing benefits and risks' above.)
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REFERENCES
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Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians
Evidence-Based Clinical Practice Guidelines. Chest 2012; 141:e637S.
37. Whitlock EP, Burda BU, Williams SB, et al. Bleeding Risks With Aspirin Use for Primary Prevention in
Adults: A Systematic Review for the U.S. Preventive Services Task Force. Ann Intern Med 2016;
164:826.
38. Stevenson DD. Aspirin and NSAID sensitivity. Immunol Allergy Clin North Am 2004; 24:491.
39. Jenkins C, Costello J, Hodge L. Systematic review of prevalence of aspirin induced asthma and its
implications for clinical practice. BMJ 2004; 328:434.
40. Grattan CE. Aspirin sensitivity and urticaria. Clin Exp Dermatol 2003; 28:123.
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colorectal adenoma. Ann Intern Med 2004; 140:157.
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cancer in men. Gastroenterology 2008; 134:21.
44. Serebruany VL, Steinhubl SR, Berger PB, et al. Analysis of risk of bleeding complications after different
doses of aspirin in 192,036 patients enrolled in 31 randomized controlled trials. Am J Cardiol 2005;
95:1218.
45. http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm390574.htm.
46. Goff DC Jr, Lloyd-Jones DM, Bennett G, et al. 2013 ACC/AHA guideline on the assessment of
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47. http://www.aspiringuide.com.
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49. US Preventive Services Task Force. Aspirin for the prevention of cardiovascular disease: U.S.
Preventive Services Task Force recommendation statement. Ann Intern Med 2009; 150:396.
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representatives of nine societies and by invited experts). Eur Heart J 2012; 33:1635.
Topic 16291 Version 26.0
GRAPHICS
Aspirin (75 to 100 mg) compared with no aspirin in the primary prevention of
cardiovascular disease and cancer
Anticipated absolute
Participants Quality of Relative effects over 10 years
Outcomes (studies), the evidence effect
Risk difference
follow-up (GRADE) (95% CI) Risk without
with aspirin
aspirin
(95% CI)
Total 100,076 (9), 3.8 RR 0.94 60 year old male

mortality* to 10 years [1] MODERATE due (0.88-1.00)
100 deaths per 6 fewer deaths
to imprecision
1000 per 1000
(from 12 fewer
to 0 fewer)
Myocardial 100,076 (9), 3.8 RR 0.80 Low cardiovascular risk

infarction (MI) to 10 years [1] HIGH (0.67-0.96) population
nonfatal events
27 MI per 1000 5 fewer MI per
1000
(from 9 fewer to
1 fewer)
Moderate cardiovascular risk

population
83 MI per 1000 17 fewer MI per

1000
(from 27 fewer
to 3 fewer)
High cardiovascular risk

population
136 per 1000 27 fewer per

1000
(from 45 fewer
to 5 fewer)
Stroke 95,000 (9), 3.8 RR 0.95 Low cardiovascular risk

includes nonfatal to 10 years [2] MODERATE due (0.85-1.06) population
ischemic and to imprecision
23 strokes per No significant
hemorrhagic
1000 difference
strokes
1 fewer stroke
per 1000
(from 3 fewer to
1 more)

population

1000 difference
3 fewer strokes
per 1000
(from 10 fewer
to 4 more)

population

1000 difference
5 fewer strokes
per 1000
(from 16 fewer
to 8 more)
Major 95,000 (6), 3.8 RR 1.54 Low cardiovascular risk

extracranial to 10 years [3] HIGH (1.30-1.82) population
bleed
8 bleeds per 4 more bleeds
1000 per 1000
(from 2 more to
7 more)

population

1000 per 1000
(from 7 more to
20 more)

population

1000 per 1000
(from 12 more to
33 more)
Colorectal 14,033 (4), HR 0.76 Low colorectal cancer risk

cancer median follow-up LOW due to (0.60-0.96) population: Anticipated absolute
(incidence) 18.3 years [4] imprecision and effect over 20 years
risk of bias
30 cancers per 7 fewer cancers
1000** per 1000
(from 12 fewer
to 1 fewer)
Moderate colorectal cancer risk

population

1000** per 1000
(from 21 fewer
to 2 fewer)
High colorectal cancer risk

population

1000** per 1000
(from 40 fewer
to 4 fewer)
GRADE: Grades of Recommendations, Assessment, Development, and Evaluation; RR: risk ratio.
* This systematic review reports total mortality and includes the most recent trials. Other meta-analyses that utilize
individual patient data report relative risk estimates for vascular mortality (RR 0.97, 95% CI 0.87-1.09), cancer mortality
(RR 0.66, 95% CI 0.50-0.87), and fatal intracranial bleeds (RR 1.73, 95% CI 0.96-3.13). The risk of a fatal bleed
(including extracranial and intracranial) was low (0.3 percent with aspirin and 0.2 percent with control).
The 95% CI for the absolute effect includes no benefit of aspirin. We did not rate down for risk of bias, but this was a
borderline decision. Three of the trials did not blind patients, caregivers, or outcome adjudicator. Sensitivity analyses in
meta-analysis by Raju et al did not show evidence of risk of bias.
Control group risk estimate for 10-year mortality apply to a 60-year-old male and comes from population-based data
from Statistics Norway. Mortality increases with age (eg, 50-year-old male; 50 deaths per 1000 in 10 years) and is lower
in females than in males (eg, 3 percent in women aged 50 years versus 5 percent in men aged 50 years).
Risk groups correspond to low (5 percent), medium (15 percent), and high risk (25 percent) according to the
Framingham score (or other risk tool) to estimate 10-year risk.
Control group risk estimates in low, moderate, and high cardiovascular risk groups are based on the Framingham score.
We have used data from an individual patient data meta-analysis to provide estimated risks for patient-important
outcomes not covered by the Framingham risk score. We have also adjusted for 20 percent overestimation associated
with Framingham risk score.
Of the strokes in the trials, 89 of 682 (13 percent) without aspirin were hemorrhagic and 116 of 655 (18 percent) with
aspirin were hemorrhagic.
In the individual patient data meta-analysis, risk for future major bleeding correlated with risk for future cardiovascular
events. Therefore, we make the assumption that a patient at low, medium, or high risk of future cardiovascular events
(determined by Framingham score) will be at low, medium, or high risk of future major bleeding events, respectively.
The 95% CI for absolute effect borders no benefit of aspirin.
** Moderate control group risk estimate derived from meta-analysis by Rothwell et al.
Major extracranial bleeds are usually from the gastrointestinal tract and are most often defined in those requiring
transfusion or resulting in death.
Treatment with aspirin during the included studies ranged from 2.6 to 6.9 years. Colorectal cancer incidence was
determined using cancer and death registries for a median of 18.3 years without knowledge of post-treatment period
aspirin use.
Control group risk estimates based on NCI Colorectal Cancer Risk Predictor Tool. Average lifetime risk for 60-year-old
female of 4.9%; 60-year old-male of 5.7%.
References:
1. Seshasai SR, Wijesuriya S, Sivakumaran R, et al. Effect of aspirin on vascular and nonvascular outcomes: Meta-
analysis of randomized controlled trials. Arch Intern Med 2012; 172:209.
2. Antithrombotic Trialists' (ATT) Collaboration, Baigent C, Blackwell L, 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.
3. Raju N, Sobieraj-Teague M, Hirsh J, et al. Effect of Aspirin on Cardiovascular and All-Cause Mortality in Primary
Prevention of Cardiovascular Disease: A Meta-analysis of Randomized Controlled Trials. Am J Med 2011; 124:621.
4. Rothwell PM, Wilson M, Elwin CE, et al. Long-term effect of aspirin on colorectal cancer incidence and mortality:
20-year follow-up of five randomised trials. Lancet 2010; 376:1741.
Modified with permission from: the American College of Chest Physicians. Vandvik PO, Lincoff AM, Gore JM, et al. Primary
and Secondary Prevention of Cardiovascular Disease: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed:
American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 2012; 141:e637S. Copyright
2012.
Graphic 86941 Version 11.0
Contributor Disclosures
Frederick A Spencer, MD Nothing to disclose Gordon Guyatt, MD Nothing to disclose Charles H
Hennekens, MD, DrPH Consultant/Advisory Boards: United States Food and Drug Administration
[Cardiovascular disease]; Pfizer [Varenicline] and its legal counsel [Atorvastatin]. Patent Holder: Co-inventor
on patents concerning inflammatory markers and cardiovascular disease held by Brigham and Women's
Hospital [C-reactive protein]. Equity Ownership/Stock Options: SunTrustBank; The West-Bacon Group has
discretionary authority and excludes any common or preferred stock in any pharmaceutical or medical device
company. Joann G Elmore, MD, MPH Nothing to disclose Christopher P Cannon,
MD Grant/Research/Clinical Trial Support: Amgen (Lipids [Evolocumab], heart failure [Ivabradine]); Arisaph
[Lipids]; AstraZeneca [ACS, lipids, and GI (Ticagrelor, Rosuvastatin, PPI)]; Boehringer-Ingelheim [AF
(Dabigatran)]; Essentialis [Lipids]; GlaxoSmithKline [Lipids and DM]; Janssen [AF and DM (Rivaroxaban and
Cangliflozen)]; Merck [Lipids (Ezetimibe)]; Regeneron [Lipids]; Sanofi [Lipids and ACS (Clopidogrel)]; Takeda
[DM (Pioglitazone)]. Consultant/Advisory Boards: Amgen [Lipids (Evolocumab), heart failure (Ivabradine)];
Bristol-Myers Squibb [AF (Apixaban)]; Lipimedix [Lipids]; Pfizer [AF, DM, and Lipids (Apixaban, Etrugliflozin,
Atorvastatin)]; Kowa [Lipids]. Gordon M Saperia, MD, FACC Nothing to disclose
Contributor disclosures are reviewed for conflicts of interest by the editorial group. When found, these are
addressed by vetting through a multi-level review process, and through requirements for references to be
provided to support the content. Appropriately referenced content is required of all authors and must conform
to UpToDate standards of evidence.
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Aspirin in The Primary Prevention of Cardiovascular Disease and Cancer

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Aspirin in the primary prevention of cardiovascular disease and cancer

A significant 6 percent reduction in all-cause mortality (RR 0.94, 95% CI 0.89-0.99).

No significant benefit on nonfatal stroke (RR 0.95, 95% CI 0.85-1.06).

Other meta-analyses have shown similar results [9-15].

A significant reduction of 22 percent in non-fatal MI over 10 years.

A possible reduction of 6 to 8 percent in overall mortality over 10 years.

The absolute bleeding risks are presented in a table (table 1).

Factors to be considered in this discussion include the following:

SUMMARY AND RECOMMENDATIONS

Use of UpToDate is subject to the Subscription and License Agreement.

1. The top 10 causes of death. World Health Organization; 2011.

U.S. Preventive Services Task Force.

Topic 16291 Version 26.0

Total 100,076 (9), 3.8 RR 0.94 60 year old male

Myocardial 100,076 (9), 3.8 RR 0.80 Low cardiovascular risk

Moderate cardiovascular risk

83 MI per 1000 17 fewer MI per

High cardiovascular risk

136 per 1000 27 fewer per

Stroke 95,000 (9), 3.8 RR 0.95 Low cardiovascular risk

Moderate cardiovascular risk

65 strokes per No significant

High cardiovascular risk

108 strokes per No significant

Major 95,000 (6), 3.8 RR 1.54 Low cardiovascular risk

Moderate cardiovascular risk

24 bleeds per 16 more bleeds

High cardiovascular risk

40 bleeds per 22 more bleeds

Colorectal 14,033 (4), HR 0.76 Low colorectal cancer risk

Moderate colorectal cancer risk

53 cancers per 13 fewer cancers

High colorectal cancer risk

100 cancers per 24 fewer cancers

Graphic 86941 Version 11.0

Conflict of interest policy

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