Aspirin as a Preventative Therapy against Cardiovascular Events

Men and women can calculate their 10-year heart attack risk at a NIH Web site- . There is an index, so go to the H for heart attack section. There you will find "Risk Assessment Tool".

(5/26/22)- The U. S. Preventive Services Task Force (USPS) recently issued its latest recommendation on aspirin usage in which it warned against usage among those 60 and older for primary prevention.


“It carries possible serious harms” namely serious internal bleeding, said Dr. John Wang, a task force member, and the interim chief scientific officer at Tufts Medical Center in Boston.


Those taking aspirin who have had previous cardiovascular events should continue to do so.


(10/15/21)-The U. S. Preventive Services Task Force (USPS), in a draft recommendation said that people in their 60s or older, who had not had a heart attack or stroke should not be taking even a baby aspirin a day. The recommendation does not apply to those who have already had a heart attack or stroke. That group should continue taking the aspirin.


The public will have a month or so to comment on this draft recommendation before the panel releases a final recommendation.


The draft recommendation is being made because the internal bleeding risk outweighs the benefits of taking the aspirin.


(4/30/20)-An analysis of the research done on 113 studies found that daily aspirin use among people aged 40 to 75 was associated with a 27% reduction in the risk for colorectal cancer; a 36% reduction in the risk for stomach cancer; a33% reduction in esophageal cancer risk; a 38% reduction in liver and gall bladder cancer; and a 22% reduction in pancreatic cancer.


For all these cancers, the favorable outcome increased with the duration of the usage. The usage had no effect on the risk of cancer of the head and neck.


The senior author of the study was Dr. Carlo La Vecchia, a professor of epidemiology at te University of Milan. Keep in mind that aspirin can cause bleeding that could be fatal.



(3/20/20)- If you think you are having a heart attack, it is recommended that after calling 911, chew a regular 325-milligram aspirin or 4 low dose ones in the hope of limiting the heart damaging effects of a clot.


Aspirin works by stopping blood platelets from sticking together to form clots that can block an artery.


Men older than 50 and women older than 60 who also have one or more risk factors for heart disease may benefit from daily low-dosage usage.


(3/19/19)- At a meeting of the American College of Cardiology and American Heart Association held in New Orleans this past weekend, they no longer recommended giving low-dosage aspirin on a routine basis for the purpose of preventing heart attacks and other heart disease in people 70 and older or adults of any age who are at increased risk of bleeding.


These guidelines apply to people who previously haven’t been diagnosed with heart disease.


(1/30/19)- A new meta-analysis of trials evaluating aspirin for primary prevention of cardiovascular disease has found no overall benefit, with aspirin use associated with a lower risk of cardiovascular events but an increased risk of major bleeding, and no effect of aspirin on cancer risk.

Sean Zheng, BM, BCh, King's College Hospital, London, United Kingdom was the lead author of the study, which was published on line in the Journal of the American Medical Association, January 29, 2019
Harold Rubin

(6/27/17)- In 2015, 20.0% of women and 9.7% of men aged ≥18 years had a severe headache or migraine in the past 3 months.

Overall and for each age group, women aged ≥18 years were more likely than men to have had a severe headache or migraine in the past 3 months. For both sexes, a report of a severe headache or migraine in the  past 3 months decreased with advancing age, from 11.0% among men aged 18–44 years to 3.4% among men aged ≥75 years and from 24.7% among women aged 18–44 years to 6.3% among women aged ≥75 years.

Source: National Health Interview Survey, 2015.

(6/20/17)- Taking aspirin for secondary prevention of stroke or myocardial infarction (MI) is associated with a higher than expected risk for disabling or fatal bleeding in people aged 75 years and older, a new observational study shows

The authors suggest that all patients aged 75 years or older prescribed aspirin for secondary prevention should also be given a proton-pump inhibitor (PPI) to protect against gastrointestinal (GI) bleeding.
The study was published online in The Lancet on June 13."

(4/11/17)- Researchers followed over 130,000 health professionals in the US for up to 32 years and found that regular aspirin users were less likely to die from colon, breast and prostate cancers, and lung cancer among men, compared with nonusers. The findings, presented at the American Association for Cancer Research's annual meeting, showed the biggest mortality risk difference was a nearly 30% reduction for colon cancer

(4/29/16)- Researchers reviewed data from 47 studies and found that patients who took low-dose aspirin after treatment for colon, breast or prostate cancer had about 15% to 20% decreased risk of mortality from the diseases, study leader Peter Elwood said.

The use of the drug was also associated with a reduction in metastasis, according to the study in the journal PLOS ONE

(4/13/16)- The U.S. Preventive Services Task Force (USPTF) released the draft of its report in September, as we noted in our item dated 9/16/15 below, even though several cardiologists noted the risk of bleeding, especially in the brain and gastrointestinal tract, but said its usage should be more restricted than the panel suggested.

The Service said men and women from 50 to 69 who are at “increased risk” from cardiovascular disease could benefit from aspirin. It also stated that aspirin could decrease the risk of colorectal cancer

(3/9/16)- A recent edition of the Journal of the American Medical Association Oncology (JAMA) contained the results of a study of the effect of aspirin on 135,9655 health-care professionals, following their health for as long as 32 years. Over the course of the study there were 27,985 confirmed cases of cancer.

Regular aspirin use reduced the risk for all cancers by about 3%. Its usage had no impact on the risk for breast, lung or prostate cancer. It reduced the risk for gastrointestinal cancer by 15% and for cancers of the colon, and rectum by 19%.

Dr. Andrew T. Chan, an associate professor of medicine at Harvard University was the senior author of the results of the study.

(10/18/15)- A new explanation has been found for how aspirin works in the body to reduce the risk of heart disease and certain cancers.

Aspirin's active form, salicylic acid, blocks a protein called HMGB1, which triggers inflammation in damaged tissues. The new findings may explain the disease-preventing effects of a low-dose aspirin regimen and offer hope that more effective aspirin-like drugs may be developed for a wide variety of diseases. (Daniel F Klessig et al. Aspirin′s Active Metabolite Salicylic Acid Targets High Mobility Group Box 1 to Modulate Inflammatory Responses. Molecular Medicine, October 2015)

(9/16/15)- For the first time, a panel of experts is recommending low dose aspirin to prevent colorectal cancer, as well as cardiovascular events for those who are at high risk for developing these ailments.

A draft report from the U.S. Preventive Services Task Force called for the usage of aspirin in the prevention to high risk individuals threatened by colorectal cancer. Nearly 40% of Americans over 50 already use aspirin for its possible preventive possibilities.

The report affirmed the usage of low-dose aspirin to prevent heart attack, stroke and colorectal cancer, and that the benefits outweighed the risks in adults aged 50 to 69. The risk of harmful internal bleeding increases with age. The recommendation is less beneficial for those 60 to 69. The national Heart, Lung and Blood Institute’s web site has a risk assessment tool on its site that will compute the possibility of your having a cardiovascular event.

There is no recommendation for those under 50 or those older than 70 as far as aspirin usage goes. Cardiovascular disease and cancer are the leading causes of death for American adults. Colorectal cancer is the third most common cancer in the U.S., causing about 50,000 deaths last year.

\(7/14/15)- The Food and Drug Administration (FDA) will require that makers of some common pain-relievers that include Nsaid medications such as ibuprofens, Celebrex, Advil, Motrin IB and Aleve revise their labels to include the fact that they cause increased risk of heart attack and strokes..

The change will require that the label state the risk is increased even within the first few usages of the medications. The change will occur for both over-the-counter and prescription brands of the medicines.

(8/31/14)- An analysis of data from two placebo-controlled studies involving 1,224 patients showed those who took aspirin after completing anticoagulation therapy were less likely to have recurrent venous thromboembolism. Aspirin was also associated with a lower rate of cardiovascular death and major vascular events such as stroke. The findings appeared in a recent edition of the journal Circulation

(8/13/14) The results of research conducted by reviewing evidence from 6 published systematic reviews and four individual studies with data on long-term baby aspirin use in people 50 to 65 years old concluded that it did help to reduce the risk of colon, esophageal and stomach cancers. There were smaller and more variable effects for protection against breast, prostate and lung cancers.

The result of the British analysts was published online in Annals of Oncology. Long term usage was required before of the positive effects could be felt. There was no benefit until at least 3 years of use, and mortality was reduced only after 5 years.

A baby aspirin of 75 to 81 milligrams was sufficient, and there was no evidence that stronger dosages would be more beneficial. Gastrointestinal bleeding was a serious and common side effect, and the risk increased with age.

(5/1/14)- Researchers who studied aspirin usage among 127,865 participants in two large national health surveys concluded that aspirin exerts a protective effect in preventing colon cancer only in people with high levels of an enzyme called 15-PGDH, which is found in the gut’s lining.

The study found only 270 cancer cases in which this enzyme was tracked. The study appears in the online edition of the Science Translational Medicine. Aspirin did not have the protective effect in patients with low level of the enzyme, while it cut the risk by 50% in those individuals who had high levels of it.

The 15-PGDH levels can be determined by doing an additional biopsy during a colonoscopy, according to Dr. Andrew T. Chan, an associate professor of medicine at Harvard.

(4/30/13)- Approximately 36% of the adult US population is estimated to take aspirin regularly for cardiovascular disease prevention. In primary prevention without previous disease, aspirin is of uncertain net value as the reduction in occlusive events needs to be weighed against any increase in major bleeds.

(3/5/13)- Results of the Clopidogrel in High-Risk Patients with Acute Nondisabling Cerebrovascular Events (CHANCE) trial were presented at the International Stroke Conference 2013. A relatively short course of aspirin plus clopidogrel immediately after a transient ischemic attack (TIA) or minor stroke outperforms aspirin alone in cutting the risk of a subsequent stroke, and it does this without a significant increased risk of major bleeding complications.

(12/25/12)- The results of a study of coated aspirin versus regular aspirin questioned the benefits of using the coated pill, which is more expensive than is the regular medication. The authors of the study concluded that there was no additional benefit in preventing strokes and heart attacks for coated aspirin over regular aspirin.

The study in question was not intended to test the effectiveness of one kind of aspirin versus another, but was meant to determine how effective aspirin is in preventing heart attacks or strokes.

The authors of the study from the University of Pennsylvania asserted that they did not find a single case of true "aspirin resistance" in any of the 400 healthy people who were examined. The study was partially funded by Bayer, the manufacturer of aspirins.

(5/10/12)- A double-blind study of 2,305 patients that compared the effectiveness of warfarin and aspirin on people with congestive heart failure found that the aspirin was just as effective as the warfarin.

Half of the patients were given regimens of warfarin and dummy aspirin, the other half aspirin and dummy warfarin. The researchers than followed the patients for up to 6 years, tracking incidents of stroke, hemorrhage and death.

The results were published in the online edition of last week's The New England Journal of Medicine. Dr. Shunichi Moma, a professor of medicine at Columbia University was the lead author of the study.

Patients who took the warfarin were less likely to have a stroke, but had an increased incidence of gastrointestinal bleeding and other hemorrhages. There were no significant differences in heart attacks or hospitalizations for heart failure

(3/30/12)- The recently published results of two studies concluded that by taking one baby aspirin every day, the risk of many cancers can be significantly reduced.

In one of the studies, researchers at the University of Oxford in England found that after three years of a daily aspirin usage, the risk of developing cancer was reduced by almost 25% when compared with a control group not taking aspirin. After 5 years, the risk of dying of cancer was reduced by 37% among those taking aspirin.

The second paper analyzed five large randomized controlled studies in England. It determined that over 6 1/2 years on average, daily aspirin use reduced the risk of metastatic cancer by 36% and the risk of adenocarcinomas (solid cancers) by 46%.

Daily use of aspirin also reduced the risk of progressing to matastatic disease, particularly in patients with colorectal cancer

Dr. Peter M. Rothwell, a professor of clinical neurology at the University of Oxford was the lead researcher for the studies, the results of which were published in the medical journal, The Lancet.

On the negative side, aspirin increases the risk of both gastrointestinal bleeding and hemorrhagic strokes.

Aspirin was originally formulated by a German chemist by the name of Arthur Eichengrun who, at that time worked for the German chemical company Bayer AG. Its generic name is acetylsalicylic.

(12/9/10) Taking aspirin over a long period of time can substantially cut the risk of dying from a variety of cancers, according to a study showing that the benefit is independent of dose, sex, or smoking.

It also found that the protective effect increases with length of time in taking aspirin. The study is by Peter Rothwell, MD, PhD, FRCP, from the John Radcliffe Hospital in Oxford, England, and colleagues, and was published online December 7 in the Lancet

A previous study by the same authors showed that low doses of aspirin (75 mgto 300 mg) reduced the number of cases of colorectal cancer by a quarter and deaths caused by the disease by more than a third. The latest study confirms the earlier results and concludes that similar effects can be shown for other types of cancers

New Aspirin Cancer Findings-The study looked at 8 trials examining the effects of a daily dose of aspirin on preventing heart attacks. It involved 25,570 patients, 674 of whom died from cancer. The researchers showed a 21% reduction in the number of deaths caused by cancer among those who had taken aspirin, compared with those who had not

The investigation also showed that the benefits of taking aspirin increased over time. After 5 years, death rates were shown to fall by 34% for all cancers and by 54% for gastrointestinal cancers

Participants were also followed-up after 20 years, at which point 1634 of the original participants had died as a direct result of cancer. This 20-year follow-up established that the risk for cancer death remained 20% lower among those who had been allocated aspirin than among those who had not for all solid cancers, including lung, prostate, brain, bladder, and kidney cancers, and by 35% for gastrointestinal cancers

The fall in the risk of death broke down according to individual types of cancer: 60% for esophageal cancer, 40% for colorectal cancer, 30% for lung cancer, and 10% for prostate cancer.

Reductions in pancreatic, stomach, and brain cancers were difficult to quantify because of smaller numbers of deaths.

Protective Effect Increases Over Time-The protective effect of taking low doses of aspirin varied according to the type of cancer and how long aspirin had been taken, the authors found. For instance, it only became apparent after about 5 years for esophageal, pancreatic, brain, and lung cancer; after about 10 years for stomach and colorectal cancer; and after about 15 years for prostate cancer.

Any benefit for lung and esophageal cancer was limited to adenocarcinomas, which are most commonly seen in nonsmokers.

Should Middle-Aged People Take Aspirin?-Previous research has linked aspirin to reductions in heart attacks and strokes, but doctors have been wary when recommending whether people should take daily doses of aspirin because of the risk for gastric bleeding. Dr. Rothwell said "the size of the effect on cancer, I think, is such that it does more or less drown out those sorts of risks."

However, he said the authors of the study do not make recommendations on taking aspirin based on this study. Peter Elwood, MD, DSc, FRCP, an expert on aspirin from Cardiff University, Wales, who was not involved in the study, said that doctors are often reluctant to recommend aspirin because "the risk of causing a bleeding . . . is going to be uppermost in a doctor's mind." A patient might interpret the risk differently, he said.

Dr. Rothwell and his colleagues say that more research is required, in particular for the effect on breast cancer and other cancers affecting women and on patients beyond the 20-year mark. The results of further trials are expected to be published in 2011.

Promising Results- Ed Yong, head of health information and evidence at Cancer Research UK, said in an emailed statement: "These promising results build on a large body of evidence suggesting that aspirin could reduce the risk of developing or dying from many different types of cancer. While earlier studies suggested that you only get benefits from taking high doses of aspirin, this new study tells us that even small doses reduce the risk of dying from cancer provided it is taken for at least 5 years.

In addition to the effect on cancer death, aspirin can affect our health in other ways, such as reducing the risk of stroke but increasing the chances of bleeding from the gut. We await trial results expected next year to learn more about these different effects.

We encourage anyone interested in taking aspirin on a regular basis to talk to their [doctor] first.

Published online December 7, 2010

(2/28/10)- According to data from IMS Health, a drug research data firm, more than 44 million packages of low-dose aspirin, which is marketed for heart attack protection, were sold in the U.S. last year.

Recently however the medical community has cautioned about overuse of the product. Aspirin has some negative side effects, which include increased risk of bleeding ulcers. With this in mind, should all of us be taking aspirin for it positive benefits? As this article points out below, there is also a great deal of scientific evidence that indicates that aspirin helps reduce the risk of colon cancer.

Under the guidelines announced by the U.S. Preventive Services Task Force last year (USPSTF) there is a difference in the recommendations for men as opposed to women. For men in the 45 to 79 year old age category with elevated heart-disease risk because of factors like cholesterol levels and smoking the recommended level is 75 milligrams a day.

Low dose "baby" aspirin contain 81 milligrams. For women, the guidelines don't focus on heart risk. In the case of females who are in the 55-year-old to 79-year-old age category the key risk is if they are in danger of ischemic stroke, for reasons that include high blood pressure and diabetes.

Aspirin acts as a blood thinner, which is believed to be the main reason for its protection against heart attack.

Aspirin is not recommended for men under 45, and women under 55 according to the guidelines of the USPSTF. There are no records to indicate whether anyone over the age of 80 benefits from taking aspiring to prevent heart attacks.

(2/22/10)- The Nurses' Health Study, is a long-running research project at Brigham and Women's Hospital in Boston. The findings of one of the aspects of the study indicated that breast-cancer patients who take aspirin daily may cut their risk of dying of the disease by up to 50% These findings were published in a recent edition of the Journal of Clinical Oncology.

The study involved 4,164 female nurses who had been diagnosed with breast cancer between 1976 and 2002. It is based on questionnaires the participants filled out on a regular basis, and on epidemiological data. The data included the period of time up to June 2006 or until their death.

The study found that those taking aspirin two to five times a week, and not more, had the best survival rates. The study measured aspirin intake at least a year after each woman had been diagnosed.

Michelle D. Holmes led the researchers. She went on to state that it did not prove that aspirin contributed to the women's survival advantage nor could they explain why aspirin might have such an benefit. She said that more clinical studies would have to be conducted before such a conclusion became a valid one.

An earlier report from the Nurses' Health Study did not find any link between aspirin use and reduced incidence of breast cancer.

The new recommendations from the US Preventative Services Task Force weigh the risks and benefits of aspirin as therapy to prevent cardiovascular problems.

For men aged 45 to 79 the recommendation is that the potential benefit of preventing myocardial infarction outweighs the potential harm of increased risk of gastrointestinal hemorrhage. For women aged 55 to 79 the potential benefit of reducing ischemic stroke outweighs the risk of increased gastrointestinal bleeding.

(8/25/09)- Researchers from Harvard Medical School, Massachusetts General Hospital and the Dana-Farber Cancer Institute, writing about their study in a recent edition of the Journal of the American Medical Association found that patients who took aspirin had a much better chance of surviving colorectal cancer than non-users. Previous studies had shown that people who took aspirins regularly were less likely to develop tumors of the colon.

The study showed that patients with colorectal cancer who regularly used aspirin before and after a diagnosis were almost one-third less likely to die of the disease than non-users. The patients were all being treated for nonmetastic, or localized, cancers, and were followed for an average of 12 years.

There were 1,279 men and women in the observational study group, all with nonmetastic colorectal cancer. This is not the type of study that is considered the gold standard, which is one in which you have a placebo group compared to a group taking the medication.

There is a clinical study that is presently underway in Asia, where the National Cancer Center of Singapore is enrolling 2,660 patients with nonmetastatic disease in Hong Kong, India, Indonesia and Singapore. The patients will continue their treatment and be randomly assigned to either get aspirin or a placebo daily for up to three years, according to the National Cancer Institute Web site.

(7/19/09)- Acetaminophen-related liver problems occur in only a very small fraction of the daily users of the products. It is estimated that it causes about 450 deaths and 56,000 emergency room visits a year. Please see item dated 7/10/09 below.

About 19% of the U.S. adult population use some form of the medication in a given week

People who drink three or more alcoholic beverages a day, or have liver disease are particularly vulnerable. Doctors can administer an antidote to an acetaminophen overdose, but it must be done with 12 hours. It is often labeled as APAP-an acronym for its chemical name, N-acetyl-para-aminophenol.

There are more cases of kidney failure, gastrointestinal bleeding and hypertension related to non-steroidal anti-infammatory medications including ibuprofen and aspirin than liver problems.

(7/10/09)- A Food and Drug Administration (FDA) advisory panel narrowly voted 20-17 to recommend a ban on Percocet and Vicodin, two of the most popular painkilling medications, because of their effects on the liver.

The two drugs combine a narcotic with acetaminophen, the ingredient found in the over-the-counter products Tylenol and Excedrin.

Acetaminophen is combined with different narcotics in at least seven other prescription drugs, and all of them will be banned if the FDA goes along with the panel's recommendation.

American consumers bought over 28 billion doses of products containing the ingredient in 2005.

The same panel in a 24 to 13 vote recommended that the FDA reduce the highest allowed dose of acetaminophen in over-the-counter pills like Tylenol to 325 milligrams from 500. In a 21 to 16 votes the panel recommended that the maximum daily dosage of acetaminophen be reduced to 2,600 milligrams from 4,000 milligrams.

Other consumer products such as aspirin and Advil do not contain acetaminophen.

(5/23/08)- All of us have heard about the beneficial aspect of aspirin as a deterrent to having a heart attack or a stroke. The question has arisen though as to what is the best time to take the aspiring, morning, noon or night? According to the results of a study that was performed by Ramon C. Hemida of the University of Vigo in Spain aspirin is most beneficial when it is taken at night.

Even though blood pressure tends to drop at night, "If you take the aspirin in the morning, it is not going to be effective because aspirin basically has an effect for four hours or so," said Dr. Hermeda. The results of the study were presented at a conference of the American Society of Hypertension.

The study was a very small one, since only 240 people with a condition known as pre-hypertension were followed for a very short period of time, namely 3 months.

Some took aspirin in the morning, while others took it at night, and a third group did not receive any aspirin. Blood pressure levels were taken for all subjects on a regular basis, and the level of physical activity of each subject was closely followed.

(2/16/08)- Researchers continue to conclude that aspirin may help reduce the risk of colon cancer, when taken in large doses over a long period of time. Dr. Andrew T. Chan, an assistant professor of medicine at Harvard who led a study of 47,000 men over an 18 year period of time concluded: "The results provide additional proof that a simple drug like aspirin can help prevent colon cancer".

The results of the study that appeared in the January issue of Gastroenterology was not a randomized study, but some other randomized studies came to the same conclusion.

After adjusting for age, smoking, diet, physical activity and other risk factors, the researchers found that men who took more than two standard 325 mg aspirins a week reduced their risk for colon cancer by about 21% compared with those who took less. Men who took 6 to 14 tablets a week reduced their risk by 28%, and those who took more than 14 pills a week had a 70% decreased risk.

The longer the men took aspirin the more they reduced the risk, but taking it for less than five years, or taking the equivalent of less than one and a half pills a week, conferred no advantage. Other non-steroidal anti-inflammatory medications like ibuprofen (Motrin) and naproxen (Aleve gave similar protections, but not acetaminophen (Tylenol).

The negative side effects of taking aspirin range from upset stomach to gastrointestinal bleeding.

(4/13/07)- Studies done on male subjects have shown that taking one baby aspirin a day is an excellent preventative for them from having heart attacks. The evidence of this happening with women is however in conflict.

A few years ago, the Women's Health Study of 40,000 women found that taking aspirin on a daily basis had no appreciable effect in decreasing the risk of heart attack for women 45 and older. On the other hand Harvard researchers recently reported that women in the university's Nurses Health Study who used aspirin regularly had a 39% lower risk of heart attack, and a 12% lower risk of getting cancer.

There were over 80,000 women who participated in the Harvard Nurses Health Study. Some medical professionals point out that it is likely that the nurses in this study were more health conscious than ordinary women would be, so that this may account for the difference between the two studies.

It is estimated that there is about a 70% greater risk of having gastrointestinal bleeding from daily ingestion of aspirins, so there is a risk factor in using aspirin whether you are a male or a female. There is also an increased risk of hemorrhagic stroke when an individual takes aspirin on a regular basis.

(5/01/06)- Harvard Medical School associate professor Daniel Simon, who has been a vocal proponent of the "aspirin resistant" effect will be beginning a study of this area under a $2 million study grant funded by Accumetrics and Schering-Plough. The study expects to enroll about 600 patients to determine if patients about to undergo angioplasty are resistant to aspirin or Plavix. (please see our item dated 3/21/06).

The Accumetrics test, which is covered by Medicare and most insurers costs the doctors and most hospitals about $20-$22. Medicare reimburses $30 for the test. The exact extent of "aspirin resistance" is unknown, but because of the fact that many of the drug companies with vested interests in discouraging the usage of aspirins, the media has been increasingly inundated with such claims..

The American Heart Association recommends that those who have suffered a stroke or heart attack take one aspirin a day, based on studies showing this regimen can reduce heart attacks and strokes by about 25%. To limit potential damage to the stomach, most doctors recommend that individuals taking aspirin on a daily basis limit it to 81-mgs a day, which is what is normally the dosage in a baby aspirin.

(3/21/06)- The anticlotting drug Plavix had over $6.2 billion in sales last year for its distributors Sanofi-Aventis SA of France and Bristol-Myers Squibb of New York. The drug has been approved for usage, along with aspirin, after a patient has had a heart attack, but the question has arisen if the drug would be useful in preventing heart attacks in individuals who are at high risk for having one. Plavix was the second most widely sold drug in the world last year, trailing only Pfizer's Lipitor in 2005.

The answer to this question seems to be no, based on the results of a study of 15,000 patients who were deemed to be at high risk for having a heart attack. These individuals were at high risk because they had had a stroke, or a blocked artery in the leg.

The drug, which is also known generically as clopidogrel, was found to be of no help in preventing a heart attack. The Plavix offered no benefit over standard low-dose aspirin therapy, and in fact it significantly increased the risk of internal bleeding. In fact, when combined with aspirin it was determined that there was only a 1-% reduction in the risk of heart attack.

The study, called Charisma, was presented at the annual scientific meeting of the American College of Cardiology in Atlanta. Both aspirin and Plavix inhibit platelets from forming clots. Researchers found that 6.8% of patients with the combination of Plavix and aspirin had either a heart attack or a stroke or died of cardiovascular disease-compared with 7.4% who were on aspirin plus placebo.

Among patients without established cardiovascular disease, the rate of death from cardiovascular causes was 3.9% for those taking Plavix and aspiriin, compared with 2.2% for those taking aspirin alone.

Plavix is approved for patients with a recent heart attack or unstable chest pain, and for people treated with drug eluting stents. Studies have shown that when such patients stop Plavix, even while continuing aspirin, they significantly increase the risk of developing a clot in the stent.

(8/30/05)- Researchers at Massachusetts General Hospital, Brigham and Women's Hospital and Harvard Medical School, all in Boston found that women who took high-doses of aspirin or certain anti-inflammatory painkillers such as ibuprofen on a regular basis for more than 10 years cut their risk of colon cancer.

According to the lead researcher for the study, Andrew T. Chan, a physician in the gastrointestinal unit of Massachusetts General Hospital and an instructor at the Harvard Medical School warned that the risk of gastrointestinal bleeding also increased as the dose of aspirin and NSAIDs increased. He said that for every one or two cases that aspirin might prevent that it could cause eight serious bleeding events.

Patients who usually take aspirins to prevent cardiovascular events usually take baby aspirin or about 80-mgs a day. Low doses of aspirin were not shown to significantly decrease the chance of colon cancer even when taken over long periods of time.

The study included 82,911 women in the Nurses' Health Study that started in 1980. Researchers studied the 20-year period from 1980 to 2000. 862 women in the study group developed colon cancer over that period of time. The study concluded that by taking 14 or more aspirins a week a woman could decrease her risk of colon cancer by 53% if they took that dosage over a 10 year period of time.

(7/11/05)- The results of a study of nearly 40,000 women concluded that they did not decrease their chances of getting lymphoma, colorectal or breast cancer, although results for lung cancer were less conclusive by taking aspirin. The study called the Women's Health Study was partially funded by the National Cancer Institute. Julie Buring of Harvard's Brigham and Women's Hospital was the lead researcher of the study whose results appeared in the latest issue of the Journal of the American Medical Association.

The women who took part in the 10-year study used doses a little higher than in baby aspirin, taken every other day and compared against placebo pills.

The results of a study of 70,144 men over a nine- year period of time concluded that aspirin was beneficial in reducing the risk of prostate cancer. The results of this study appeared in the recent edition of the Journal of the National Cancer Institute. The researchers in this study asked the men about their use of aspirin and other non-steroidal anti-inflammatory drugs, including ibuprofen, such as Advil and Motrin. Men who took standard 325-mg doses of those medicines daily for at least five years were about 18% less likely to get prostate cancer then men who used aspirin occasionally for a shorter duration.

(3/19/05)- A major 10-year study that was funded by the NIH suggests that aspirin affect men and women differently when it comes to preventing first heart attacks and strokes. The study involved nearly 40,000 women aged 45 and older. It suggests that a regular every-other-day regimen of low dose aspirin was effective in preventing a first stroke in women, but had no effect in helping avoid a first heart attack. The women in the study had no history of cardiovascular disease.

This is the exact opposite in regards to men as determined in previous studies. In those studies it was suggested that aspirin where low-dosages of aspirin helped to prevent a first heart attack, but if anything, it may slightly increase the risk of strokes. The result of the landmark study for men was published in 1989, and has pretty much been the gospel since then.

For healthy women younger than 65, the benefits of taking aspirin regularly are limited. It is important that each individual, male or female, discuss this matter with their own physician before deciding whether or not to embark on an aspirin regimen. It is well recognized that whether you are male or female, aspirin reduces your risk of subsequent risk of cardiovascular disease.

According to data from the American Heart Association, it was estimated that 345,000 women had heart attacks in 2002, while 373,000 of them suffered a stroke in that year. For men in 2002, 520,000 had heart attacks and 327,000 suffered strokes in 2002.

The U.S. Preventive Services Task recommends routine low-dose aspirin for adults (male or female), whose risk of having a heart attack over the next 10 years is 6%-based on such risk factors as age, cholesterol levels, smoking status and blood pressure.

(1/8/05)-An estimated 17,000 people die each year due to gastrointestinal complications from non-steroidal anti-inflammatory drugs such as naproxin. "Enteric coated" aspirins are meant to deal with this problem. Enteric coated aspirins have coating that permits the pill to move through the stomach to the small intestine before the medication is released.

Enteric coated aspirins relieve but do not eliminate entirely the gastrointestinal risk. A study published in the April 1994 Journal of Rheumatology followed 350 patients with osteoarthritis or rheumatoid arthritis who had stopped using pain relievers within the past year because of gastrointestinal complaints. The study showed that 16% of patients using the enteric-coated aspirins developed gastrointestinal problems compared with 25% in the standard naproxen group. Both medications worked equally in relieving the pain symptoms.

Enteric-coated aspirins costs about $1.22 per tablet versus the cost of about 28 cents a pill for the naproxen. Your doctor can provide a prescription for enteric-coated pills, but please keep in mind that many FSA plans cover over-the-counter medications as well as prescription drugs. A small Irish study found that enteric-coated aspirins do not prevent platelets from clumping as well as low-dosage aspirin. "All aspirin appears to be beneficial whether it's enteric-coated or not," says William Frishman, chief of medicine at Westchester Medical Center in Valhalla, N.Y.

(10/22/04)-The benefits of taking aspirin may not help everyone. New evidence shows that up to 25% of the population are aspirin resistant. Since it is estimated that over 20 million Americans take aspirin to prevent heart attacks or strokes, this means that a substantial percentage of the users are non-responsive to the medicine. Recently it has been determined that aspirin takers who are resistant have a higher rate of heart attacks and strokes than do nonresistant aspirin users.

New tests have evolved that can determine who is resistant to aspirin consumption. The standard test of how readily platelets clump is called aggregometry. It is both an expensive and time consuming test, since the test itself used to take between two to three hours to administer. A lab needed to be used to determine the results. Doctors who determine that their patients are resistant to aspirin have been recommending Plavix as a substitute for aspirin. Plavix, know generically as clopidogrel, is jointly marketed by Bristol-Myers Squibb and Sanofi-Synthelabo. Plavix costs about $3 a pill, so there is a big cost differential between it and aspirin.

Scientists have been unable to determine why some people are resistant to aspirin, but hopefully this question will be answered shortly.

New tests have recently come to play in this area, and they are cheaper and much less time consuming. Accumetrics, a small company in San Diego received clearance from the FDA at the end of 2003 for its VerifyNow test. This test can be performed in the doctor's office and the results are ready within minutes. The tests range in price from $30 for VerifyNow to $100 for some of the newer tests that are on the market.

The results of a recent research study showed that women who are prone to hormone sensitive breast cancer could benefit from taking aspirins. The hormone estrogen stimulates about 60% to 70% of all cases of breast tumors. Breast cancer is the most common type of cancer in women, with 215,990 cases and 40,110 deaths expected this year from the disease.

Women who took aspirin 7 or more times a week had a 26% lower risk of developing those tumors than women who did not take it, according to the results of the study done under the leadership of Mary Beth Terry. Dr. Terry is an assistant professor of epidemiology at the Mailman School of Public Health at Columbia University.

For women not already taking aspirin, Dr. Terry said "the only fair thing would be to have the woman take it or not based on what her physician recommends given her overall health profile." More research must be reported on however before it can be unequivocally stated that aspirin can be used as a preventative against hormone type breast cancers.

Researchers at the University of North Carolina and the Mount Sinai School of Medicine in New York also participated in the study. Dr. Andrew J. Dannenberg, an author of the study and the director of cancer prevention at the Weill Cornell Medical College in Manhattan concurred in the thought that eventually aspirin may be recommended in preventing the recurrence of breast cancer in women who have had breast cancer.

The study included 1,442 women with all forms of breast cancer and 1,420 without the disease. Among the women with cancer 301, or 20.9% had taken aspirin at least once a week for six month or longer. Of the health women, 345, or 24.3% had taken aspirin. The suggestive protective effect showed only an association and did not prove cause and effect.

Recently, The US Prevention Service Task Force (USPSTF), a group of private-sector experts on prevention and primary care issued new recommendations about the benefits of aspirin as a preventative therapy. It had been known that aspirin is a preventative benefit to protect against second incidence of cardiovascular disorders, following the first occurrence. In fact, many cardiologists view aspirin as the backbone of preventative cardiology as well as treatment after coronary syndromes. They indicate that aspirin’s protective benefit increases as cardiovascular risk increases.

In order to come up with their recommendations, The USPSTF reviewed various studies, which were recognized as scientifically sound, involved randomized trials, lasted more than a year, and in which individuals were without cardiovascular disease. These studies showed that aspirin reduced coronary heart disease by 28% in patients without cardiovascular disease.

This meta-analysis also determined that aspirin could benefit any patient at increased risk of cardiovascular events-defined as a >3% risk of experiencing coronary heart disease events (primarily heart attacks) over the next 5 years. The chief investigator, Dr. Pignone, assistant professor of medicine, University of North Carolina, Chapel Hill indicated that these recommendations are based on quantifying, rather than estimating, cardiac risk. The method to quantify this risk can be found on the Internet at The risk factors that increase the chances of a cardiac event include hypertension, diabetes, hypercholesterolemia, and family history of cardiac events and smoking.

Recently there have been several studies that show that daily use of aspirin cut the risk of a heart attack by an average of 28% for those who did not have a prior heart attack. Although aspirin does increase the risk of internal bleeding, it has not been shown that it helps prevent ischemic strokes, which occur when a clot cuts off blood flow to the brain.

For people who have a low risk of having a heart attack, the risks associated with aspirin ingestion exceed the benefits afforded by taking the drug. The Internet has several sites that help you evaluate your 10-year risk of having a heart attack. Some of the sites are: and .

The calculators will ask your age, blood pressure and cholesterol levels among other things. The U.S.Preventive Services Task Force recommends that the benefits outweigh the negatives for those whoes 10-year risk is at least 6%. Like everything else in this world not every one will benefit from aspirins. Doctors at the Cleveland Clinic found that 9% of the patients that they tested appeared "resistant" or that their blood did not have the usual blood thinning effects associated with taking aspirin.

Most of the studies that have been done on the effect of aspirin involved middle aged men, so it is only recently that studies have begun to show what effect taking aspirin will have on the female population.

The 75 to 81 mg dosage of aspirin that the task force recommends is considered a low dose. For those individuals at less than 3% probability of a five-year risk of experiencing a cardiac event, aspirin best be avoided because of adverse reactions including GI bleeding or hemorrhagic stroke.

Some researchers indicate that enteric-coated aspirin at 325-mg dosages may have a more robust effect than the 75-81 ordinary aspirin. One such researcher is Feng and his group who studied forty healthy male subjects in a randomized, double blind, parallel study design. They looked at platelet inhibitory and prostacycline-sparing effects of the two doses of aspirin-81mg of ordinary aspirin and 325 mg of enteric-coated aspirin.

They found that 325-mg enteric-coated aspirin inhibited collagen induced aggregation to a greater degree than 81-mg dose. They concluded "that this additional platelet inhibitory power may have significant clinical relevance in situations such as acute coronary syndrome (e.g., acute myocardial infarction and unstable angina) which are mediated by plaque rupture and involve significant collagen exposure and subsequent platelet activation and aggregation." (See: Feng D L, McKenna C, Murillo J et al. Effect of Aspirin Dosage and Enteric Coating Platelet Reactivity. Am J. Cardiol 1997; 80:189-193). The study also showed that enteric-coated aspirin provides better prostacycline-sparing effects than the lower dose aspirin. Prostacycline is known to be a vasodilator and inhibitor of platelet aggregation.

Dr. Tobias Kurth led a study done at the Harvard Medical School and the Brigham and Women's Hospital in Boston that concluded that the taking of other painkillers on a steady basis along with the ingestion of aspirin inhibited the protective anti-heart attack benefit of taking the aspirin alone. "However, if you took them intermittently or casually, you were not effected," said Dr. Kurth. Aspirin has an anti-coagulant effect and that is one of the reasons given for its benefit in preventing heart attacks.

Aspirin, ibuprofen, naproxen and other similar drugs are called non-specific anti-inflammatory drugs. They work by interfering with two enzymes called Cox-1 and Cox-2. Ibuprofen turns off Cox-1 temporarily, making it safer than aspirin, but it seems to compete with aspirin when the two are regularly taken together. Taking a dose of aspirin daily has been shown to reduce the risk of a heart attack by about 44%.

"What this shows is that it's hard to beat aspirin," said lead researcher Philip Gorelick of Rush-Presbyterian-St. Luke's Medical Center in Chicago in discussing the results of a study he lead which compared aspirin to ticlopidine in trying to prevent strokes among blacks. The research involved 1,809 black men and women who took aspirin or ticlopidine for as much as two years.

As a matter of facts the study showed that aspirin was even better than the ticlopidine in preventing strokes. A month's supply of aspirin costs about $10, while and equivalent supply of ticlopidine costs about $100. An estimated 700,000 Americans suffer strokes each year. Blacks have about double the risk of strokes than do whites. Ticlopidine is sold under the brand name of Ticlid and it was approved in 1991 to treat strokes for patients who can not be given aspirin. Roche Laboratories, a division of Roche Holding AG of Switzerland makes the drug.

After angioplasty, a patient is subjected to a wide assortment of different medications. These include aspirin to prevent clots, an ACE inhibitor to regulate blood pressure, and a statin to lower cholesterol levels. Patients who have suffered a heart attack are also usually advised to take beta-blockers as well as these other medications.

According to Steven R.Steinhubl, a cardiologist and researcher at the University of North Carolina at Chapel Hill, who led a study on the effects of the super aspirin Plavex after angioplasty, this one medication may be enough to do the job by itself.

Bristol-Myers Squibb Co. and Sanofi-Synthelabo of France, co-market Plavex (clopidogrel), which currently has over $1 billion in sales. According to the study patients who take the drug for one year after undergoing angioplasty have a 27% less chance of dying or suffering a heart attack or stroke. The study involved 2,116 patients of whom about 85% had stents implanted as part of the angioplasty procedure. The researchers found that one-year after the procedure, 8.5% of the patients who were given Plavex suffered a heart attack, stroke or died versus the 11.5% of the control group. On the down side of the study, more of the Plavex patients did suffer a severe bleeding episode compared to the control group.

Dr. Dennis T. Mangano founder of the Ischemia Research and Education Foundation of San Francisco wrote up the results of a study paid for by the foundation, that involved giving aspirin to patients within 48 hours after they had heart surgery. The patients in the study were treated at 70 hospitals in 17 countries from 1996 to 2000. The study concluded that giving heart bypass patients aspirin within 48 hours after having heart bypass surgery greatly reduced their risk of death and serious complications involving the heart, brain, kidneys and digestive tract.

Over 355,000 Americans had heart bypass surgery in 1999, the last year for which the figure is available. Many doctors fear giving aspirin to bypass patients because aspirin does increase the risk of internal bleeding. According to the study, the death rate of patients who were given aspirin within 48-hours after bypass surgery was only 1.4%. For those not given aspirin within 48-hours, the death rate was 4%.

The patients in Dr. Mangano's study were not picked at random in regard to who would and who would not receive the aspirin. Thus a randomized controlled study will have to be undertaken to confirm these results.

An advisory panel of the FDA concluded its hearings in regards to the labels on common painkillers such as acetaminophens, ibuprofen, naproxen and aspirins. As a result of these hearings the advisory panel will recommend to the FDA that stronger warning labels are needed for these painkillers. The FDA is expected to act on these recommendations early in 2004. The panel did not question the safety of these products when taken as directed, but questions have arisen in connection with misreading of the labels and overuse of these products.

The panel found evidence that thousands of Americans unwittingly take toxic doses of acetaminophen, which is the main ingredient in almost 200 over-the-counter cold and headache remedies, including Tylenol. The panel voted 23-1 in favor of recommending to the FDA that stronger warnings be required on the labels of all acetoaminophens. Acetaminophen is also found in painkillers such as Percocet and Vicodin.

The panel recommended that every package of a drug that contains acetaminophen states in bold type on the label that it contained the ingredient. It also recommended that the label state in bold letters that taking more than the recommended dosage could result in liver damage. Johnson & Johnson has already undertaken this steps in connection with the labels on Tylenol.

The panel also stated that certain groups of patients, such as the elderly should be warned that they risk stomach bleeding or kidney failure by taking the class of medicines known as nonsteroidal anti-inflammatory drugs known as NSAIDs. Included in the NSAID category are aspirin, ibuprofen, found in Motrin and Advil, and naproxen found in Aleve.

Researchers have noted that acetaminophens (Johnson & Johnson's Tylenol is the best known of these products) can cause liver problems over time, and aspirins can cause gastrointestinal bleeding with prolonged use. John Jenkins, head of the FDA's Office of New Drugs stated that "We'd like to do a better job of preventing some of these (adverse effects)." The advisory panel's recommendation is usually upheld by the final decision of the FDA.

In an interesting side-note to the panel's hearing, each product side in the debate is emphasizing the weakness of the other side, while minimizing the weak points of their own drug. An FDA review of acetaminophen overdoses found that consumer calls to poison-control centers about acetaminophens decreased from 111,175 in 1995 to 108,102 in 1999. Deaths however associated with the drug's overdose rose from 76 to 141 in the same period. The number of deaths included death from suicide as well as from accidental overuse.

It is almost a given that the geriatric population has some cardiovascular risk. Cardiovascular disease resulted in 958,775 deaths in the United States in 1999. This total represented 40.1% of all deaths or to put it another way, one out of every 2.5 deaths were the result of cardiovascular disease. The number of women who died was greater than the number of men, reflecting that a larger proportion of women than men are living into the oldest age range.

It is a good idea to talk with your primary care physician before you start any regimen of aspirin. You want to optimize the outcome of use of aspirin and minimize the risks. Please also see our article Colon Cancer in regards to some interesting study results in connection with the usage of aspirin and its possible effect in reducing the risk of colon cancer.

Please also see our article: The Role of Aspirin in Ischemic Stroke-Part V


Allan Rubin and Harold Rubin, MS, ABD, CRC, Guest Lecturer
updated May 26, 2022

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