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Two Studies: Similar Results, No Benefits from Stroke Drugs

Aug 28, 2008 | Parker Waichman LLP

Two recently-released, separate studies on medications used in the prevention and treatment of stroke both question the benefit of blood pressure medicine and a popular blood thinner for use in the prevention of stroke recurrence.  In the first study, patients who were taking the blood pressure drug Micardis (telmisartan) were no less likely to have another stroke than those patients who were taking a placebo.  The second study found that when aspirin was combined with the anti-platelet drug Persantine (dipyridamole), the combination also performed no better than the standard anti-clotting treatment Plavix (clopidogrel)for reducing the chance of stroke.

"We found no evidence that either of the two treatments was superior to the other in the prevention of recurrent stroke," said Ralph Sacco of the University of Miami.  Sacco led the study.  "Even though, in science, you always strive to find a superior treatment, in this case it gives us options for treatment depending on the patient and their response to the different medications."  Both research papers were released online by the New England Journal of Medicine and were based on the “Profess" study.  The Profess study reviewed data from 20,332 patients from 695 medical centers located in 35 countries.

The drug clopidogrel is a Bristol-Myers Squibb drug that is marketed under the brand name Plavix.  Boehringer Ingelheim GmbH makes dipyridamole and markets that drug under the brand name Persantine.

Stroke kills about five million people worldwide every year and suffering from high blood pressure increases the risk of stroke.  Also, when a patient survives a stroke, that person experiences an eight percent increased likelihood of suffering from another stroke within one year.

It was because of these data, telmisartan—which Is sold under a variety of brand names—was prescribed to half the study volunteers; that study was let by Salim Yusuf of McMaster University, Ontario, Canada.  Telmisartan is sold as Boehringer Ingelheim's Micardis or Pritor and Bayer Schering Pharma’s Kinzal brands.

After two and a half years of study follow-up, the researchers found that 8.7 percent of the patients taking telmisartan suffered another stroke as compared to 9.2 percent of patients suffering another stroke in the placebo group. The less-than-one-percent increase was described as insignificant.  The drug, which is an angiotensin-receptor blocker, had no effect on the risk of heart attack, or other major cardiovascular events, or diabetes.  

Among volunteers receiving Plavix, 8.8 percent in the Plavix group suffered an additional stroke versus 9 percent of the patients in the aspirin-dipyridamole combination group.  Also, the risk of major bleeding was similar in both groups.  "Furthermore, there was no significant difference between the two treatments in the risk of fatal or disabling strokes," the researchers wrote.

Drs. David Kent and David Thaler of the Tufts University School of Medicine in Boston agreed the findings were confusing.  The study was funded by drug maker Boehringer Ingelheim.


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