News this month
FDA updates
recommendations
for aspirin

Last October the Food and Drug Administration announced a new rule that expands on the recommended prescribed uses of aspirin for patients with cardiovascular disease. The FDA announcement, which is based on the agency's ten-year evaluation of multiple studies in the U.S. and abroad (see below), updates the recommendations it proposed in 1988 and 1996 for men and women who have had a heart attack or stroke or are at high risk for them.

New uses of aspirin approved
According to the FDA's October rule, aspirin has been shown to reduce the risk of the following medical conditions:

• Heart attack in those who have had a heart attack or experience angina (chest pain)
• Death or complications from 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 angioplasty
• Stroke in those who have had a previous stroke or who have had a warning sign called a transient ischemic attack (mini-stroke).

Guidelines approve lower doses
The ruling reduces the recommended doses for cardiovascular use. One aspirin tablet is 325mg.

Not recommended for everyone
The FDA report emphasizes consumers should consult with their physicians to ensure that aspirin is appropriate for their conditions. The risk and benefit of each available treatment for each patient must be weighed. The same quality that gives aspirin its potential benefit–its ability to inhibit clotting of the blood–may increase the risk of excessive bleeding. That's why aspirin is not recommended for decreasing the risk of heart attack in healthy individuals.

Possible risks include:

• Stomach irritation. Aspirin can irritate the stomach lining and cause heartburn, pain, nausea, vomiting and over time, more serious conditions such as internal bleeding and ulcers. People who consume more than three alcoholic drinks per day may be at increased risk of stomach bleeding and liver damage.
• Ringing in the ears. At high doses, aspirin can cause temporary ringing in the ears or hearing loss. This condition usually reverses itself when the amount of aspirin is reduced.
• Allergy. Approximately two out of 1,000 people are allergic to aspirin and experience facial swelling and occasionally asthma attacks.
• Reye's syndrome in children. Aspirin should not be used for flu-like conditions or chickenpox in children because of the risk for this serious disease.

Read labels
The FDA recommendations apply only to aspirin. Tylenol (acetaminophen), Advil (ibuprofen), Aleve (naproxyn sodium) and Actron (ketoprofen) are good drugs for pain and fever, as is aspirin, but only aspirin has been shown to have a beneficial effect on reducing the incidence of heart attacks and strokes.

Supporting research
SAPAT. The Swedish Angina Pectoris Aspirin Trail (SAPAT) was a randomized, double-blinded study of 2,035 subjects with chronic stable angina pectoris. The study was carried out in several research institutions. The medication group received 75 mg of aspirin daily plus the beta blocker sotalol. The placebo group received a placebo plus sotalol. Among those taking aspirin, there was a significant reduction in risk of fatal or nonfatal heart attack and sudden death, as well as first occurrence of heart attack or stroke. There was an increased number of bleeding episodes in the aspirin group, but the difference was not statistically significant.

U.S. Physician's Health Study. In this study, five investigators examined 333 men with baseline chronic stable angina, randomly assigning them to receive alternate-day aspirin therapy (325 mg.) or placebo. Subjects were followed for 60.2 months. Of the 27 patients who experienced heart attacks, seven were in the aspirin group and 20 were in the placebo group, an 87 percent reduction in risk for those using aspirin.

SALT. The Swedish Aspirin Low-Dose Trial included 1,360 subjects with a history of stroke. The subjects took either 75 mg of aspirin or a placebo daily. After 32 months, aspirin was superior to the placebo in prolonging the period of stroke-free survival and reducing the severity of heart attacks. The placebo group experienced 68 heart attacks, 28 of which were fatal, compared to the aspirin group which experienced 54 heart attacks, 18 of which were fatal. Aspirin reduced the risk for nonfatal stroke or death by 18 percent. There were 112 cases of fatal and nonfatal stroke in the placebo group compared to only 93 in the aspirin group.

The SALT study suggests some negative side effects of taking aspirin as well: The risk of bleeding and fatal hemorrhagic stroke was larger in patients taking aspirin. The aspirin-treated group experienced 16 cases of fatal stroke compared to ten in the nonaspirin group. Also, 12.4 percent of aspirin subjects experienced adverse GI reactions, exclusive of bleeding, compared to 10.7 percent of the placebo group. More than seven percent of the aspirin group experienced stomach or intracranial bleeding compared to three percent of placebo patients

The European Stroke Prevention Study Part 2 (ESPS-2) helped confirm the usefulness of aspirin. Researchers enrolled 6,600 patients, half on a daily dose of 50 mg of aspirin, half on a placebo. After two years, the risk of stroke was reduced by 18 percent when subjects took aspirin compared to the placebo group. The most common side effect was stomach bleeding.