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Study Casts Doubt on Plavix-Aspirin Combo for Stroke Prevention

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A new study found that the Plavix-aspirin combination for stroke prevention might not be as effective or safe as initially believed. The research revealed that the combination was no better than aspirin alone in second stroke prevention for people whose first stroke was—for the most part—the result of high blood pressure, said HealthDay News. The Canadian researchers noted that the Plavix-aspirin combination also increased risks for gastrointestinal bleeding and death. “Antiplatelet therapy is standard for the prevention of a second stroke,” study author Dr. Robert Hart, a professor of neurology at McMaster University in Hamilton, Ontario, told HealthDay News. “We wanted to see if combining two antiplatelet drugs, aspirin with clopidogrel [Plavix], would work better and prevent more strokes. We were disappointed that the combination of aspirin plus clopidogrel only showed a non-significant trend in reducing stroke,” Hart added, noting that “On the other side, the two together caused more bleeding and higher mortality. The higher mortality was completely unexpected. It is clear that the two drugs together should not be routinely used in people with lacunar stroke.” A lacunar stroke takes place in the brain’s small blood vessels; is typically due to chronic high blood pressure, accounting for about one-fifth of all strokes; and is generally seen in diabetics, Blacks, and Hispanics. While smaller in nature, this type of stroke can cause disability, depending on the event’s brain location, explained HealthDay News. People who have suffered a lacunar stroke are typically prescribed antiplatelet therapy to reduce their risk of a second stroke.. The report appears in the August 30 issue of the New England Journal of Medicine. The research team randomly assigned more than 3,000 lacunar stroke patients to either a Plavix-aspirin or placebo-aspirin combination. Patients were randomly assigned either the aggressive or standard blood pressure control protocols, said HealthDay News. In the eight years of follow-up, the rate of second strokes in the Plavix-aspirin group was 2.5 percent, versus 2.7 percent in the aspirin-only group; most second strokes were lacunar, the team pointed out. Overall, second strokes in both groups were reduced three-fold, more than was expected. The rate of serious bleeding, however, was significantly higher in the Plavix-aspirin group—2.1 percent, versus 1.1 percent in the aspirin only group. In fact, there were more deaths in the Plavix-aspirin group—113—versus 77 deaths in the aspirin group. The reason for the increased death rate, although still unknown, is under investigation, Hart told HealthDay News. The trial was stopped in August 2011 due to the results and the U.S. National Institutes of Health (NIH), which funded the study, issued a warning that there was “little likelihood of benefit in favor of aspirin plus clopidogrel [Plavix] [for] recurrent stroke, should the study continue to conclusion.” The blood pressure treatment portion of the trial continues and patients have been urged to continue taking aspirin without Plavix, said the NIH, wrote HealthDay News. Current guidelines recommend either aspirin alone, Plavix alone, or aspirin with Permole (dipyridamole), for stroke prevention in patients who already suffered a stroke, “I am a little surprised, but not shocked by this finding,” Dr. Kirk Garratt,

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director of interventional cardiovascular research at Lenox Hill Hospital, in New York City, told HealthDay News. “It’s another disappointing finding for antiplatelet drugs. The lesson here is we shouldn’t start writing prescriptions for Plavix to those patients with lacunar strokes. Practitioners have to pay attention to these negative trials.”

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