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Boehringer Drugs Disappoint in Company-Sponsored Stroke Study

By Michelle Fay Cortez

Aug. 28 (Bloomberg) -- Boehringer Ingelheim GmbH's Micardis hypertension drug was no better than a placebo in preventing recurring strokes, a company-sponsored study found.

Previous research has shown that lowering blood pressure reduced strokes and suggested drugs like Micardis may have additional benefits. The findings come from the Profess trial of 20,332 patients that was released online by the New England Journal of Medicine. The study also showed that Boehringer's blood thinner Aggrenox combined with aspirin was no better than a top-selling competitor, Plavix, in preventing stroke recurrence.

The results from both arms of the study were surprising. Earlier studies show a more aggressive blood-pressure decrease protects against stroke, researchers said. The Micardis analysis shouldn't invalidate those findings, they wrote. Many doctors also preferred the dual action of Aggrenox and aspirin to Plavix from Bristol-Myers Squibb Co. and Sanofi-Aventis SA for thinning the blood to prevent repeat attacks.

``In the case of Profess and the tangle of related trials, enlightenment might be expressed simply, as a haiku: For stroke prevention/ use an antiplatelet drug/ Treat hypertension,'' the researchers wrote.

In the first report, 8.7 percent of patients on Micardis had another stroke within 2 ½ years, compared with 9.2 percent of those given a placebo, a difference that failed to meet the threshold of statistical significance. Micardis also didn't lower the risk of major heart complications or diabetes in the trial. Patients all received other hypertension drugs at their doctor's discretion.

Boehringer Ingelheim, of Ingelheim, Germany, is the world's largest closely held drugmaker.

Not Long Enough

It is possible the study didn't last long enough to find a benefit, said the researchers, led by Salim Yusuf, a professor of cardiology at McMaster University in Ontario. In addition, the patients had lower starting blood-pressure levels and a smaller reduction than seen in previous trials. Two longer studies are now under way that may provide clarification, researchers said.

A second analysis of the study found 9 percent of patients getting Aggrenox and aspirin had another stroke, compared with 8.8 percent given Plavix. A combination of stroke, heart attack and death from vascular problems was identical at 13.1 percent, and more patients getting the combination had serious bleeding.

``There is no evidence that either of the two treatments was superior to the other in the prevention of recurrent stroke,'' said the researchers, led by Ralph Sacco from the University of Miami's Miller School of Medicine.

Kent and Thaler wrote that aspirin and Aggrenox, known as dipyridamole, was the ``clear favorite'' against Plavix when the study started. Now all the evidence suggests that the medicines, including aspirin alone, are relatively similar in benefit. As a result, effectiveness shouldn't be the only factor used to choose treatment, they wrote.

Aspirin costs pennies a day, while the other drugs are 100 times more expensive, they wrote. In addition, side effects, dosing schedules and tolerability are different for each patient, and should be taken into account, they said.

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To contact the reporter on this story: Michelle Fay Cortez in Minneapolis at mcortez@bloomberg.net

Last Updated: August 28, 2008 00:00 EDT

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