Study touts new blood clot pill - exceeded high expectations for millions of people with atrial fibrillation -

Study touts new blood clot pill - exceeded high expectations for millions of people with atrial fibrillation - 

An experimental pill to prevent blood clots exceeded already high expectations as a better therapy for millions of people with atrial fibrillation, according to final results of a worldwide study released Sunday.

The study was featured at the European Society of Cardiology in Paris and simultaneously published on the website of The New England Journal of Medicine.

"It's a remarkable achievement," said Dr. Valentin Fuster, a past president of American and world heart associations, who was not involved with the trial. "This is one of the most significant advances in cardiovascular medicine in the last five years, no question."

The twice-daily pill, to be called Eliquis, prevented 21 percent more strokes than the blood thinner warfarin, a standard treatment for heart arrhythmia, and resulted in 31 percent fewer incidents of major bleeding over an average of 1.8 years in the study.

Eliquis also reduced total deaths by 11 percent, a mortality benefit its makers, Bristol-Myers Squibb and Pfizer, plan to trumpet in a marketing campaign, assuming the Food and Drug Administration approves the drug this year.

Newer anticoagulant drugs that act on clotting enzymes are not without disadvantages. They cost much more than generic warfarin, roughly $8 a day instead of $1 or less. And they wear off much faster if users miss a dose, raising the risk of stroke. Eliquis and another new product, Pradaxa, require two pills a day, in the morning and evening, instead of the once-daily, longer-acting warfarin.

The study included 18,201 people in 1,034 clinical sites in 39 countries and was consistent worldwide, the sponsors said. Although the study was financed by the drugmakers, which raises the issue of bias, it was a randomized, double-blinded trial in which doctors and patients did not know who took which pill until the end.

More than 2.6 million people have atrial fibrillation in the United States, according to the Centers for Disease Control and Prevention. As many as 12 million people will have it by 2020 because of an aging population with longer life expectancy. The arrhythmia in the left upper chamber of the heart can cause slow blood flow and clots, raising the risk of stroke by four to six times on average, the government says.

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