If you ever watch TV, you may be able to recall an aspirin commercial, where a patient is recalling how popping an aspirin at the onset of a heart attack saved their life. Or you may be able to recite the recent Plavix commercial, where half the commercial is about how Plavix can save your life, and then the last half is about all the increased risk of bleeding, etc., while taking Plavix. Needless to say, we’ve all heard it. But, some of us don’t really think twice about the dangers involved if you were to combine the 2.
However, if you are taking either one of these medications, it might benefit you to realize how deadly this combination could potentially be. So much, that a stroke-prevention study has been stopped involving the combination because of increased rates of bleeding and death, versus taking aspirin along.
The 3,000-patient study was funded by the National Institute of Neurological Disorders and Stroke, which issued a clinical advisory last month about the early termination of the Plavix-aspirin arm of the study.
The study is called SPS3 for “Secondary Prevention of Small Subcortical Strokes.” According to a report from The Wall Street Journal, the study, was being conducted by the National Institute of Neurological Disorders and Stroke (NINDS). It was designed to determine if Plavix-aspirin therapy could prevent recurring strokes in people who had recently suffered “subcortical” strokes, which occur in the small blood vessels of the brain. Such strokes, though milder than others types, can reoccur and damage to the brain can build up over time. People who suffer subcortical strokes are predisposed to dementia, the Journal said.
SPS3 began in 2003 and was testing whether Plavix–a widely used blood thinner co-marketed by Bristol-Myers Squibb Co. (BMY) and Sanofi SA (SNY)–together with aspirin could prevent these subcortical strokes.
NINDS said it took action after a data-safety monitoring board found in the summer that 6.5% of patients treated with the Plavix-aspirin combination experienced a bleeding event, versus 3.3% of those on aspirin alone. Also, there were more deaths from all causes in the combination group than in the aspirin group, 5.8% versus 4.1%.
What’s more, an analysis showed that the Plavix-aspirin combination was unlikely to provide a significant benefit in stroke prevention if that portion of the study continued to its conclusion.
“For stroke…the combination does not offer any protection but does put you at increased risk for bleeding,” said Walter Koroshetz, deputy director of NINDS.
He noted, however, this finding is consistent with current medical guidelines, which recommend against use of the combination for secondary stroke prevention based on prior studies. This advice is now extended to people with recent small subcortical strokes.
Bristol-Myers spokeswoman Laura Hortas said the prescribing label for Plavix notes that its use with aspirin in people with recent stroke has been linked to increased risk of bleeding. The label also notes that the combination wasn’t shown to be more effective than Plavix alone in people with recent stroke.
The new study also doesn’t affect the approved uses of the Plavix-aspirin combination to prevent future heart attacks, strokes and other cardiovascular events in people with acute coronary syndrome, a condition that includes chest pain associated with heart attacks or unstable angina.
Researchers will continue a portion of the study that is testing whether blood-pressure medications can prevent strokes and cognitive decline. It is expected to be completed in April 2012.
SPS3 was the first test of whether a combination of Plavix and aspirin could prevent recurring strokes in people with prior subcortical strokes.
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