'An Aspirin a Day' -- Just Another Cliché?

Asprin is commonly used in conjunction with cannabis to synergistically enhance the pain killing qualities of both....
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'An Aspirin a Day' -- Just Another Cliché?

There was a time when only one brand of aspirin existed, and its manufacturer's 1920s ad campaign was intended to assure consumers that aspirin would not damage their hearts.

But we now know that aspirin can affect the heart. Today, aspirin is actually prescribed under its various generic and name brands for its heart-healthy effects.

"DOES NOT AFFECT THE HEART." That assurance in the Bayer aspirin ads of the 1920s spoke to concerns of the day that some drugs could damage the life-sustaining organ. Today it's clear that aspirin can affect the heart. Ironically, it turns out the effects are beneficial, so much so that some aspirin ads now carry the American Heart Association's seal to highlight the cardiovascular effects.

In fact, of the 80 million aspirin tablets Americans take each day, most are taken not for everyday aches and pains but to reduce the risk of heart disease, according to aspirin manufacturer Bayer Corp. (See "Aspirin's Other Uses.")

Based on studies showing aspirin's usefulness in treating cardiovascular disease, including heart attack and stroke, the Food and Drug Administration has approved its use to treat some of these serious conditions. Most recently, in 1998, FDA finalized a rule to give doctors updated information about the use of aspirin for men and women who have had a heart attack or stroke or are at high risk for them.

"Used the way it should be, the information should save a lot of lives," says Debra Bowen, M.D., deputy director of one of FDA's drug review offices.
"In addition," she says, "the information should reduce adverse reactions and allow doctors to better target those who need to use the product."
Beyond Pain Relief

As summarized in FDA's 1998 rule and in the updated professional labeling for aspirin, the 100-plus-year-old drug has been shown to reduce the risk of the following medical problems:

* stroke in those who have had a previous stroke or who have had a warning sign called a transient ischemic attack (mini-stroke)
* heart attack in those who have had a previous heart attack or experience angina (chest pain)
* death or complications from a heart attack if the drug is taken at the first signs of a heart attack
* recurrent blockage for those who have had heart bypass surgery or other procedures to clear blocked arteries, such as balloon angioplasty or carotid endarterectomy.

Under the rule, the recommended doses for cardiovascular uses are lower than those doctors had been prescribing since this new use became popular: generally, 50 to 325 milligrams once daily (75 to 325 milligrams for angina and previous heart attack).

Scientists believe that aspirin's ability to reduce the body's production of hormone-like "prostaglandins" is the reason for both its effectiveness in relieving pain and reducing inflammation and its protective effects against heart attacks and strokes.
Prostaglandins, it seems, can cause platelets in the blood to stick together, which can eventually lead to blocked blood vessels and can prevent delivery of oxygen-rich blood to the tissues.

"When a clot forms in the brain, it can cause a stroke, and in the heart, a heart attack," explains George Sopko, M.D., the head of the Interventional Cardiology Scientific Research Group at the National Institutes of Health. Reduce the prostaglandins, and you reduce the risk of dangerous blood clots, heart attacks, and strokes.

"Aspirin is a great drug: effective, cheap, and relatively safe," Sopko says. "The drug has been used by just about everybody, so it may not have the sex appeal of newer drugs, but it can have a huge beneficial impact if used properly. Looking at aspirin's impact, on heart attacks for example, it may be equal to or better than some drug therapies that cost thousands of dollars."

Other pain relievers and fever-reducing drugs, such as acetaminophen, ibuprofen, naproxyn sodium, and ketoprofen, have not been shown to have aspirin's beneficial impact on cardiovascular health.
"It's not the pain-relieving quality that is the major thrust of aspirin's beneficial cardiovascular effects," Sopko explains, "but its pharmacological effect on platelets."

Not for Everyone

Although aspirin is a familiar and readily available drug, people shouldn't take it for its cardiovascular benefits without discussing the risks of long-term use with a doctor, cautions Charles H. Hennekens, M.D., chief of preventive medicine at Brigham and Women's Hospital in Boston. "If someone feels they're a candidate, they should talk to their doctor in making the judgment if the benefits outweigh the risks."

The same quality that gives aspirin its potential benefit--its ability to inhibit clotting of the blood--may increase the risk of excessive bleeding, including the possibility of bleeding in the brain. Some other possible risks are:

* Stomach irritation. Aspirin can irritate the stomach lining and cause heartburn, pain, nausea, vomiting, and, over time, more serious consequences such as internal bleeding, ulcers, and holes in the stomach or intestines. Chronic alcohol users may be at increased risk of stomach bleeding, as well as liver damage, from aspirin use.

* Ringing in the ears. At high doses, aspirin may cause temporary ringing in the ears and hearing loss, which usually disappear when the dose is lowered.

* Allergy. Facial swelling and sometimes an asthma attack may occur in the two out of 1,000 people who are allergic to aspirin, according to the Mayo Clinic in Rochester, Minn.

* In children, Reye syndrome. While not a problem among candidates for cardiovascular aspirin use, aspirin should not be used for children's flu-like symptoms or chickenpox because of the risk of this rare but serious disease.

Because of its risks, aspirin is not approved for decreasing the risk of heart attack in healthy individuals.
Even Hennekens isn't ready to recommend an aspirin a day for everyone, although he headed up the celebrated 1988 "Physicians' Health Study," which showed aspirin's protective effects in healthy people.

Why can't this so-called "wonder drug" help everyone?
Hennekens' example: A 30-year-old woman's risk of a heart attack is typically "very small," even over the next 30 years. "It would be unfortunate if such a young woman was taking aspirin," he explains, "because it would give no benefit and could cause gastrointestinal effects or dangerous bleeding."
Head Start

In the wide range of patients who could see large benefits, aspirin, regrettably, is not used nearly enough, according to Hennekens.
Studies bear this out, including a 1998 survey of elderly heart attack survivors entering nursing homes, which found that fewer than one in five were taking aspirin.

According to the American Heart Association, 5,000 to 10,000 of the 900,000 lives lost each year to cardiovascular disease could be saved if more people took aspirin upon the first signs of a heart attack.
Some typical signs are an uncomfortable pressure or pain in the center of the chest (sometimes along with lightheadedness, fainting, shortness of breath, nausea, or sweating) or a pain going to the shoulders, neck and arms.

Aspirin should be used by "just about everyone" who has survived a heart attack or stroke due to a blocked blood vessel, Hennekens emphasizes, or who within the previous 24 hours has had symptoms of an evolving heart attack.


While appropriate aspirin use is important, experts say it is by no means a cure-all.
"In the time crunch surrounding a heart attack, taking an aspirin provides you a head-start therapy and a better chance for a good outcome," Sopko says. "But it should never be a substitute for a physician's attention."

And aspirin should not replace a healthy lifestyle or other helpful medical steps, FDA's Bowen says.
"Physicians really need to look at aspirin in the context of complete care, as part of a whole treatment plan for people at risk of heart attack or stroke."


Aspirin's Other Uses

Aspirin is sometimes used to treat rheumatoid arthritis, juvenile rheumatoid arthritis, osteoarthritis, and some other rheumatological diseases.
Aspirin labeling was updated in 1998, and now provides information on specific dosing, side effects, and toxicity of aspirin for these conditions.

More potential medical uses for aspirin are still under study--everything from treating migraines and colon, ovarian and breast cancer to improving brain function.
Could an aspirin a day help you retain your memory as you age by preventing clogging of the arteries in the brain? It remains to be proven, but early studies suggest it's possible.

Three Drinks = No Pain Relievers

Aspirin and all other over-the-counter pain relievers and fever reducers for adults will soon carry a warning to people who drink three or more alcoholic beverages a day: Talk with your doctor before using these drugs. Heavy drinkers may have an increased risk of liver damage and stomach bleeding from these medicines, which contain aspirin, other salicylates, acetaminophen, ibuprofen, naproxen sodium, or ketoprofen.

The alcohol warning is required under an FDA rule (distinct from the aspirin labeling rule), which was finalized in 1998 and gives manufacturers some time to make the label changes. Some newer over-the-counter pain relievers, including Aleve (naproxyn sodium), Orudis KT and Actron (ketoprofen), Advil Liquigels (solubilized ibuprofen), and Tylenol Extended Release (acetaminophen), have already been required to carry a warning for heavy drinkers but were not required to include the specific risks. These products, too, will need to comply with the 1998 rule.
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For More Information on Aspirin and the Heart:

American Heart Association
http://www.americanheart.org/presenter.jhtml?identifier=1200000

Aspirin Foundation of America
http://www.aspirin.org/

SECOND THOUGHTS ABOUT ASPIRIN A DAY TO PREVENT HEART ATTACKS

A baby aspirin a day keeps a heart attack away.
This widely accepted health practice was seriously undermined at an advisory committee meeting of the Food and Drug Administration (FDA, held in December 2003.
The FDA advisory committee voted overwhelmingly to reject a petition from the Bayer Corp. to approve aspirin for reducing the risk of a first heart attack.

Though an estimated 20 million Americans already take low-dose aspirin daily to prevent a heart attack, this is an off-label use—that is, the aspirin manufacturers have not received FDA approval for this particular indication. FDA approval is required, however, once an aspirin manufacturer plans to advertise the drug for this use. And once approval is granted, the drug's packet insert must be rewritten to inform consumers of the new indication.

Bayer's petition made the FDA Cardiovascular and Renal Drugs Advisory Committee take a critical look at the five trials (One trial compared aspirin with vitamin E) in which people without heart disease took either aspirin or a placebo (a dummy pill).
Altogether there were more than 55,000 participants at anywhere from low to high risk for a heart attack.
Here is what the cardiologists and other experts on the committee found in the way of benefit: Aspirin produced about a 32% reduction in non-fatal heart attacks. [Translation: An estimated 3% of all moderate-risk people will have a heart attack in the next five years. Daily low-dose aspirin therapy will reduce their odds to about 2%.] The benefit is given in terms of a five-year period because the trials lasted four to seven years.

Several things troubled the FDA committee members about the results of these trials: Aspirin did not have any mortality reduction benefit; nor did it reduce the odds of having an ischemic stroke, which is, arguably, the most feared consequence of heart disease. Yet aspirin has the potential for causing another, less common type of stroke called hemorrhagic stroke, which is a rupture of a blood vessel in the brain.

One committee member who voted to reject Bayer's petition is Steven Nissen, MD, Medical Director of the Cleveland Clinic Cardiovascular Coordinating Center. In a telephone interview, Dr. Nissen explained, “The data [from the five trials] were terribly weak.” You always have to weigh the trade- offs , he said, referring to hemorrhagic stroke as the major concern.

But the aforementioned 32% reduction in non-fatal heart attacks applies to the combined total of all the study participants, most of whom were men with differing levels of risk. The committee hit a snag once it came to individuals. Dr. Nissen said that he and other committee members were concerned that daily aspirin, if taken by people at a low enough risk, could cause more harm than good. Asked to define “low enough risk,” he explained that there was too much uncertainty to answer the question. “No one in the world can answer the question of who benefits and who doesn't, and if there is no answer, then how could I vote to approve?” he asked.

The fact that women were underrepresented in the five trials (only 20% of all participants) also troubled Dr. Nissen. “It may be that the risks exceed the benefit for women,” he said, “but we simply don't know—there is not enough data.” Still, Dr. Nissen was careful to stress that he was not against aspirin therapy for everyone, suggesting that people talk over the decision with their physicians. The FDA advisory committee “took a lot of heat,” said Dr. Nissen, referring to its decision to turn down Bayer's petition and thus reject the prevailing medical view that aspirin therapy is good for just about everyone. “We were called flat earthers ,” he said.

The FDA is not obligated to follow the decisions made by its advisory committees, but the agency usually does.
The committee's decision, though entirely appropriate, illustrates how the current system works against consumers who want to become fully informed before they go on lifelong drug therapy.
Approval would have meant a rewrite of the drug's packet insert to include the new indication. And this, in turn, would have compelled the advisory committee to identify the appropriate group of people for whom the benefit of aspirin therapy clearly outweighs the risks.

The evidence from the five trials did not provide the answer; therefore, 20 million people will continue to take daily aspirin without knowing anything about the uncertainties of the supporting research.

The advisory committee's concerns can be contrasted with the practice guidelines aimed at physicians and published in 2002 by the U.S. Preventive Services Task Force.
The Task Force concluded that the number of “cardiac events” prevented by aspirin therapy far exceeded the number of hemorrhagic strokes caused by aspirin therapy.
This, too, is based on the combined results of the same five trials.
When the Task Force tried to break things down for individuals, it came up with this estimation for moderate-risk men and women:
“For 1,000 patients with a 3% risk of having a heart attack in the next five years, aspirin would prevent eight heart attacks but would cause one hemorrhagic stroke and three major gastrointestinal bleeding events.”

Where it concerns low-risk people, the Task Force is in agreement with the FDA advisory committee:
“…patients at low risk for coronary heart disease probably do not benefit from and may even be harmed by aspirin because the risk for adverse events may exceed the benefits…” (Annals of Internal Medicine, 1/15/02).