Published: May 7, 2014 | Updated: May 7, 2014
By Todd Neale, Senior Staff Writer, MedPage Today
The FDA issued a message to consumers stating that the evidence does not support the “general” use of aspirin for the primary prevention of heart attacks and strokes.
“In fact, there are serious risks associated with the use of aspirin, including increased risk of bleeding in the stomach and brain, in situations where the benefit of aspirin for primary prevention has not been established,” the agency said, adding that the benefits of aspirin outweigh the risks in the setting of secondary prevention.
The message came shortly after the FDA denied a request from Bayer to change aspirin’s label to reflect an indication for primary prevention.
Not all organizations agree with the FDA’s stance, however.
The American Heart Association recommends using aspirin for primary prevention in patients with an elevated risk for coronary disease. In guidelines for the primary prevention of stroke, the AHA wrote: “The use of aspirin for cardiovascular (including but not specific to stroke) prophylaxis is recommended for persons whose risk is sufficiently high for the benefits to outweigh the risks associated with treatment (a 10-year risk of cardiovascular events of 6% to 10%) (Class I; Level of Evidence A).”
The U.S. Preventive Services Task Force recommends aspirin use for primary prevention in men ages 45 to 79 when the expected reduction in the risk of myocardial infarction outweighs the potential harm of gastrointestinal bleeding and in women ages 55 to 79 when the expected reduction in the risk of stroke outweighs the potential harm of GI bleeding. But it is not recommended in younger patients, and the task force found insufficient evidence to make a recommendation in those 80 and older.
MedPage Today asked primary care physicians (and a few cardiologists) what impact the FDA’s announcement would have on their practice, and here are their responses.
Jason Rice, MD, Loyola University Health System, Chicago
I do not routinely recommend that otherwise healthy patients without risk factors for cardiovascular disease take a daily aspirin for primary prevention of cardiovascular events. There is a lack of compelling evidence to suggest that the benefits of daily aspirin use outweigh the risks to routinely recommend this therapy across the board. There are likely patients with a significant constellation of risk factors that may still benefit from aspirin therapy, and I typically have a discussion with these patients on an individual basis to discuss the available data on risks and potential benefits so that an educated decision can be made with the patient’s participation in the conversation.
As I already am not routinely recommending aspirin for primary prevention, this announcement will likely not cause a dramatic change in my practice. It appears that more research needs to be done to better identify the at-risk population that may benefit from aspirin in the absence of prior cardiac events. I think, as with most decisions made in medicine, guidelines should be used to guide rather than dictate decisions. Guidelines are an excellent tool to assist in medical decision-making, but they should not replace individual patient assessments and thoughtful discussions with each individual patient regarding specifics of their medical care.
Pedro Cazabon, MD, Ochsner Health System, New Orleans
This is a complicated clinical issue, because there are several factors to consider for each unique patient. As a primary care physician for an adult population, I use situations like this to discuss the importance of informed decision-making on medical interventions. The answer is going to be different for different patients, often contingent on their healthcare risks and goals. I see a topic like this as an opportunity to build teamwork into the relationship with my patients.
William Manard, MD, Saint Louis University
The evidence supporting use in patients without prior cardiovascular disease has always been somewhat thin. Therefore, I’ve always approached this from a patient-centered approach, similar to what now is recommended for lipid-lowering therapy. For example, a 50-year-old male with well-controlled hypertension on a single agent without significant family history or other risk factors could probably forgo aspirin therapy. On the other hand, the same patient with poorly controlled hypertension, diabetes, who is also overweight and smokes, I would likely recommend (in addition to other risk factor mitigation) use of aspirin. The FDA’s announcement will change little in my approach. As I’ve always had questions about universal usage of aspirin, recommendations to not do so would not change this approach.
Andrew Davis, MD, MPH, University of Chicago
Clinicians in our practice had been aware of these potential risks for at least a decade, and were already cautious in suggesting a baby aspirin in patients without a prior heart attack or similar vascular issues. Patients without previous vascular events, but who have poorly controlled hypertension have an especially high risk of bleeding in the brain from a baby aspirin. As we found out from the risks of high-dose vitamin E, a poorly chosen extra ounce of prevention can sometimes cause a pound of harm. Promoting such actions can be driven more by companies seeking marketing advantage than by strong scientific evidence.
Len Horovitz, MD, Lenox Hill Hospital, New York City
Recent FDA guidelines have changed regarding the routine use of aspirin for men over 55 and women over 65. Several studies have found there there is more risk of significant bleeding (gastrointestinal and stroke) than prevention of first heart attack. So “routine” prescribing of aspirin has been called into question. For those who have had a heart attack, the role aspirin is still extant. Some studies, however, have shown that there is primary stroke prevention using aspirin in women over 65, and some cardiologists intend to continue prescribing aspirin for primary prevention in patients with clear coronary risk factors.
Richard Sadovsky, MD, SUNY Downstate Medical Center, Brooklyn, N.Y.
Occasionally, I will recommend aspirin as primary prevention to patients with multiple risk factors for cardiovascular disease, most notably family history and smoking, after a discussion about the risks and benefits. Actually, all use of aspirin is preceded by a discussion of risks and benefits. Most of my patients with diabetes also are placed on aspirin because of the equivalence considered between diabetes and coronary artery disease. The current FDA notification will not change my recommendations for prophylactic use of aspirin.
The recommendations of the USPSTF on prophylactic use of aspirin note that among men, if the risk of a cardiovascular event (MI) exceeds a certain level, then the potential benefit exceeds the risk, and prophylaxis is recommended. These guidelines are currently under review. Please note that these recommendations are for men between ages 45 to 79 and my comments pertain, for the most part, to male patients. Data on women and indications for women are less well explored.
J. Jacques Carter, MD, MPH, Harvard Medical School and Beth Israel Deaconess Medical Center, Boston
The “should you” or “shouldn’t you” take aspirin issue has flipped and flopped multiple times over the past decade or so. For patients with significant cardiac risk factors, most of my colleagues would probably recommend it to their patients. At one point, it was recommended for all “middle-aged adults,” risk factors playing no major role. I used to recommend it to my middle-aged patients who had no known bleeding risks. However, we can see occasional bleeding in anyone, even with no past history of same. Sometimes the bleeding can be life threatening. This is why I stopped recommending it to my patients unless they had cardiac risk factors. The new FDA recommendations are in line with my current practice.
Laura Lingle Whiteley, MD, Memorial Hermann Medical Group-Memorial City, Houston
In general, if a patient does not have a previous history of cardiac events, I do not recommend daily aspirin therapy. At this time, I feel the risks (bleeding, ulcers, bruising) outweigh the benefit. I have not found convincing evidence that daily aspirin therapy prevents or reduces cardiac events in a primary prevention setting without previous cardiovascular disease. That being said, every patient and every case is different and this is something that every patient should discuss with their PCP. This FDA release does not change what I am already doing. I will continue to monitor the literature and adapt my position as the evidence supports.
Marc Itskowitz, MD, Allegheny General Hospital, Pittsburgh
The efficacy of aspirin in the primary prevention of heart disease is controversial. Aspirin has not been shown to lead to a statistically significant reduction in the rates of stroke or cardiovascular death. Patients should discuss the risks and benefits of taking a daily aspirin with their doctor. In most cases, aspirin for primary prevention is not recommended unless there is a strong family history of coronary artery disease along with other major risks factors. Judgments about prescribing long-term aspirin therapy for patients at intermediate cardiovascular risk should be made on a case-by-case basis. The decision should involve the estimation of the risk of an important vascular event and the risk of major bleeding.
Clarence Williams II, MD, Scott & White Round Rock Urgent Care Clinic, Texas
Clearly the benefits of aspirin outweigh the risks in cases where people have already experienced a stroke or a heart attack but in people without history of atherosclerosis … not so clear. The FDA stance on aspirin is one that should cause physicians to pay closer attention to who we advise to take aspirin. The adverse effects can be catastrophic.
I do advise certain patients without cardiovascular disease to take daily aspirin to prevent cardiovascular events. Obviously no two patients are the same and the risk of an adverse effect must be weighed versus the benefit of possibly slowing down or stopping cardiovascular events. In a high-risk patient I would still recommend daily aspirin. I believe one of the major reasons aspirin is indicated for secondary prevention of cardiovascular events is because after an event, clearly there is benefit. Risk versus benefit easily favors benefit in this situation. The American Heart Association (and other organizations) have not changed their stance on this situation, so clearly further investigation is needed.
There is some evidence that aspirin may be associated with a reduction of nonfatal heart attacks but the finding has not been demonstrated consistently across trials. At this point I will work harder to identify “high-risk” patients and discuss possible adverse events more thoroughly with the patient prior to starting aspirin therapy.
Lianne Marks, MD, PhD, Scott & White Clinic, Round Rock, Texas
Utilization of aspirin for primary prevention has become a one-on-one doctor-patient discussion, not unlike prostate cancer screening. We always wish as physicians that there are clearly defined preventative strategies valid for all patients, but the art of medicine is to cater certain types of information to individual patients. Aspirin is one of these therapies where a universal recommendation cannot be applied — risk-benefit ratios vary greatly among different people depending on their bleeding and cardiovascular risk. This has changed my practice as I am less likely to recommend aspirin in individuals aged 50 to 75 than previously due to the evolution of available evidence, now showing a lower rate of benefit then previously suspected.
Basil Dudar, MD, Beaumont Hospital, Grosse Point, Mich.
Aspirin at a low dose (81 mg) for “primary prevention” has been shown in multiple studies and meta-analyses to reduce the risk of first MI. However, there is always a risk of bleeding. Thus, I recommend aspirin, low dose, for primary prevention on an individual basis when weighing the risk of bleeding versus benefit of preventing myocardial infarction. There are methods available to estimate the risks and benefits from the Framingham study as well as the USPSTF. This FDA statement has not changed my practice as I will continue to recommend aspirin for primary prevention on an individual basis.
Anu Lala, MD, NYU Langone Medical Center
I do not routinely advise patients without cardiovascular disease to take aspirin daily to prevent cardiovascular events, but rather try to make an individual assessment of their “benefit-to-risk” ratio. What ensues is a discussion with each patient that is unique to their clinical profile. The FDA’s announcement is in in line with my practice. Having examined the data for aspirin in primary prevention in detail, I have felt that the argument for aspirin in patients without clinical cardiovascular disease is not strong. Rather, aspirin use should be carefully considered on an individual basis.
Matt Handley, MD, Group Health, Seattle
It is all about your risk. The higher one’s risk of a heart attack or stroke, the greater the benefit. For low-risk people the benefit does not outweigh the small risk. For higher-risk people the benefit does exceed the risk.
From the American Heart Association: