What’s new in stroke therapies?

Stroke is the leading cause of severe disability and the fifth-leading cause of death for all Americans. The burden is worse in minority communities; minorities have higher stroke risks, strokes at an earlier age, and more severe strokes. For example, African Americans are twice as likely to die from a stroke compared to Whites.

Often this is because people do not know the warning signs (e.g., sudden numbness, confusion, or loss of balance) or the risk factors that lead to stroke, like high blood pressure, diabetes, and an irregular heart rhythm (atrial fibrillation, or AF). Some minority groups also suffer disproportionately because of cultural and language barriers, which can lead to a delay in treatment or not seeking treatment at all.

Aspirin therapy: Who should use it?

Although there is broad agreement about the benefits of aspirin in secondary prevention of stroke (the use of aspirin in people who have already had a stroke), there has been debate in the scientific community about the benefits and risks of using aspirin for primary stroke prevention, i.e., in people without a prior stroke. The Food and Drug Administration (FDA) has not recommended that use.

Here is the latest evidence on who should and should not use aspirin for stroke prevention:

Primary prevention: In patients who have never had a stroke, aspirin therapy can increase their risk for bleeding in the stomach and brain, and a reduction in strokes with aspirin has not been established.

Secondary Prevention: In patients who have already had an ischemic stroke, which happens when a blood vessel that supplies blood to the brain becomes blocked by a blood clot, aspirin therapy has been shown to decrease the risk of having a subsequent event. In general, the benefits may outweigh the risks for these patients.

Aspirin is, of course, readily available in drug stores and grocery stores. Before using it, however, patients should discuss with their healthcare providers whether aspirin therapy is the right course of action for stroke prevention.

Drug trials snapshot: Savaysa

On another note, In January 2015 FDA approved Savaysa, a drug used to reduce the risk of stroke in patients with AF, a type of abnormal heart rhythm. This is a blood-thinning medication similar to several other recently approved anti-coagulants and an older drug, warfarin.

All of these drugs reduce the chance of stroke in patients with this condition by more than 50 percent. But note that for patients with kidneys that work really well, Savaysa did not work as well as warfarin.

More than 21,000 people with AF participated in the Savaysa clinical trial. Clinical trial data showed a large stroke reduction and no meaningful differences by sex, race (Whites versus Asians), or age (greater than 75 years) for the drug’s performance or side effects (e.g., major bleeding), a finding that is also true for the other anti-coagulants. Other minority groups were underrepresented in this trial, so data are not available for those groups.

The FDA strives to make data transparent and easily accessible to our stakeholders. The Office of Minority Health is leading FDA’s efforts to encourage diversity of participants in clinical trials and assess possible differences in effects among varying groups.

We know that demographic subgroups (e.g., minorities, women) can respond differently to medications, and clinical trial participants should reflect the populations that will most likely use these products.

Information provided by the FDA. Visit the FDA website or follow them on Twitter to find out more information about their research programs, outreach, and communications.

Jovonni R. Spinner, M.O.H., C.H.E.S. is a public health advisor in FDA’s Office of Minority Health.