Approval of the Citizen Petition would yield labeling regarding the prescribing of aspirin to include men over 40 and women over 50 at risk for heart attacks due to additional risk factors -- even if they haven't had one yet -- as recently recommended by the United States Preventive Services Task Force and The American Heart Association.
In compiling a summary of the five landmark clinical trials of the use of aspirin in the primary prevention of heart attacks, as well as summaries of guidelines and analyses that have been developed from the landmark trials, the Citizen Petition supports professional labeling that could be communicated to physicians for this new use.
In particular, the American Heart Association's (AHA) recent guidelines and the United States Preventive Services Task Force's (USPSTF) recent recommendations both encourage broader use of aspirin in the primary prevention of heart attacks in appropriate patients. The Citizen Petition is positioned to encourage the FDA to adopt these groups' guidelines into professional labeling for aspirin.
Determination of who is an appropriate candidate for aspirin therapy is a decision that must be made in consultation between doctor and patient.
Current Labeled Uses of Aspirin
Bayer has worked closely with the FDA to turn scientific findings into labeling that educates physicians and patients on the benefits of aspirin therapy. This collaboration between industry and the FDA has led to a number of important approvals for the use of aspirin to enhance cardiovascular health. These include:Aspirin's Milestones in Cardiovascular Uses
1980: The federal Food and Drug Administration (FDA) recognized the use of aspirin to reduce the risk of stroke after a transient ischemic attack in men.1988: FDA approves use of aspirin to prevent a recurrent heart attack and first heart attack in people with unstable angina, and the use of aspirin to reduce the risk of stroke after TIA in men.
1988: "Second International Study of Infarct Survival" was published in The Lancet. The study focused on 17,000 patients in 400 hospitals who took aspirin no later than 24 hours after the onset of a heart attack and for one month thereafter. This landmark study showed that aspirin dramatically reduces the chance of dying or having a subsequent heart attack if administered at the time of a suspected heart attack and continued for 30 days.
1989: "The Physicians' Health Study," published in The New England Journal of Medicine, focused on 22,000 healthy American physicians, who took either 325 mg of aspirin or a placebo every other day. Regular aspirin administration reduced the incidence of heart attack by 44%. The study was stopped after five years rather than eight as planned. Those taking the placebo were then allowed to switch to aspirin therapy, given its impact on heart attack prevention.
1998: The secondary prevention labeling was broadened to include additional uses and doses, and most importantly recognized the benefits of aspirin to prevent stroke in women.
Use During Acute MI: In the most dramatic of newly approved uses, the FDA is recognizing aspirin's potential to reduce the risk of death if taken as soon as a heart attack is suspected as directed by a physician. The FDA agreed with research that concluded that as little as one-half (162.5 mg) of a regular- strength aspirin tablet reduces the risk of death by up to 23 percent if administered when a heart attack is suspected and for 30 days thereafter.*
Expanded Use for Stroke Prevention: The FDA confirmed the use of aspirin to prevent a stroke in women who have suffered a transient ischemic attack (TIAor mini-stroke), and to prevent a second or recurrent stroke in both women and men who have previously suffered a stroke.
Use for High Risk Individuals: The FDA broadened aspirin's role to include preventing heart attack and stroke in certain high-risk individuals. This includes patients with clinical evidence of blockage to heart blood vessels such as those with a type of chest pain known as stable angina. Millions of American are in these high-risk categories.
Use of Lower Dosages: For heart attack and stroke prevention, the FDA also endorsed the use of aspirin in lower dosages such as 81 mg, or one-quarter of a regular-strength tablet, responding to research suggesting that lower doses can minimize potential side effects but still maintain efficacy.
*ISIS-2 study details available on request.
