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Monday, March 13, 2006A startling new study has doctors rethinking the practice of prescribing the blood thinner Plavix in combination with low-dose aspirin to patients at risk of a first heart attack or stroke. The international study included more than 15,000 patients with heart disease or risk factors for heart disease. The conclusion: The tandem therapy was of some benefit to those with diagnosed heart disease, but it nearly doubled the risk of death, heart attack or stroke in patients with heart-threatening conditions such as high cholesterol and high blood pressure. Study co-author Dr. Eric Topol, a professor of genetics at Case Western Reserve University in Cleveland and a leading U.S. heart expert, urged doctors Monday to stop prescribing Plavix (clopidogrel) plus aspirin to patients who have not had a previous heart attack or stroke. Plavix is most commonly used in people who have already had strokes or heart attacks. It isn't commonly used as a first line therapy for stroke and heart disease protection in people who've never had either. At least, it isn't used that way in my neck of the woods. Doubling the risk of death does, indeed, sound dire. If it's that dangerous for people who haven't had strokes or heart attacks, why is it safe for those who have? Aren't they worse off to begin with? Well, maybe that's the point. They have less to lose and more to gain. Here's Dr. Topol's study (Don't you love the name? "Charisma"). He and his coresearchers divided 15,603 people who had either actual cardiovascular disease (but no prior strokes or heart attacks) or multiple risk factors for heart disease and stroke and divided them up into two groups. One group received Plavix and aspirin for 28 months and the other received a placebo and aspirin for 28 months. They then counted how many in each group had heart attacks and/or strokes, both fatal and nonfatal. They found that 6.8 percent of the Plavix and aspirin group had such events compard to 7.3 percent of the aspirin and placebo group. That seems a plus for Plavix. But, when they looked closer and considered only a sub-group of patients who had no known cardiovascular disease - only risk factors - they found that 6.6 percent of the Plavix and aspirin group had events compared to only 5.5 percent of the aspirin and placebo group. And when they narrowed it even further, to consider only those subjects who met with death by heart attack or stroke during the 28 months of the study, the difference was 3.9% vs. 2.2% - the "nearly doubled" risk of death, or an absolute difference of 1.7%. Well, that's a difference, but not a big one. The better lesson to take home from the study is that Plavix ($117 per month) plus aspirin isn't much better than aspirin alone ( $2.00 a month) in preventing strokes and heart attacks. The other news out of the cardiologists' get-together is that the fashionable use of B-vitamins and folic acid to prevent heart disease doesn't measure up to scrutiny. The study (full text here) really didn't find much difference in the rates of death, heart attacks, and strokes between a folate/B-vitamin complex and a placebo. At least, nothing beyond a percentage point or two, despite the decrease in homocysteine levels among the vitamin users. Oh well, at least they aren't expensive. posted by Sydney on 3/13/2006 09:24:00 PM 1 comments 1 Comments:
I heard the presentation by the researcher who did the B vitamin study. One of the panelists for ACC commended her for presenting "negative" research results. She was quite elegant in her response and pointed out that the results were not "negative", rather neutral. The audience applauded.
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