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 Web site 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,” Dr. Fuster, chairman of federal and medical panels on atrial fibrillation and director of the heart center at Mount Sinai Medical Center in New York, said in an interview.
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 later this year. Barring any problems, sales are quickly expected to reach billions of dollars.
The new drugs are not without disadvantages. They cost much more than generic warfarin, roughly $8 a day instead of $1 or less. And Eliquis and Pradaxa require two pills a day, one in the morning and one in the evening, instead of the once-daily 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 drug makers, which raises the issue of bias, it met the gold standard for medical research as a randomized, double-blinded trial in which doctors and patients did not know who took which pill until the end. The drug acts on an enzyme that leads to blood clots.
Dr. Christopher B. Granger, the study’s lead author and a professor of medicine at Duke University, said, “I think this is a profound trial result that will have a major impact on the practice and management of patients with atrial fibrillation. It combines both greater efficacy in terms of prevention of stroke with a substantial reduction to bleeding risk, and that package is one that will be particularly compelling.”
Wall Street has high expectations, too. The companies’ stock soared after they released a brief statement about the stroke and bleeding benefits in June. Barclays Capital said the final results on Sunday were “perhaps the most anticipated R.D. event of the year.”
“If everything checks out,” Jami Rubin of Goldman Sachs said in an interview, “that will confirm in our minds that Eliquis has potential to take a majority share of the $10 billion anticoagulation market.”
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.
As many as half of people with the condition, however, are untreated, by varying estimates. Warfarin, a cheap 60-year-old drug sold generically under the brand name Coumidin, requires frequent blood tests to monitor its active level and interacts with some other drugs and foods, including leafy greens. There is great appeal and demand for new drugs that do not vary so much and deliver the same stroke-preventing benefits.
The first new drug, Pradaxa, from the German drug maker Boehringer Ingelheim, was introduced in the United States last fall. In the first seven months on market, about four in five cardiologists and two in five primary care doctors had prescribed it to more than 250,000 people, Wa’el Hashad, Boehringer’s vice president for cardiovascular marketing, said in an interview last week.
Pradaxa inhibits thrombin, an enzyme in clot formation. Other emerging drugs block a related enzyme known as Factor Xa.
Xarelto, from Bayer and Johnson Johnson, approved by the F.D.A. in July to prevent clots in hip and knee replacement surgeries, goes to an F.D.A. review panel for atrial fibrillation on Sept. 8.
Eliquis is scheduled to be submitted for F.D.A. review later this year. Its New York-based makers are marketing powerhouses with the top two best-selling drugs in the world, Lipitor from Pfizer and Plavix from Bristol-Myers Squibb. Patents on those drugs expire in the next year, making Eliquis even more important to their businesses.
Article source: http://www.nytimes.com/2011/08/28/business/trial-shows-potential-for-blood-clot-pill-eliquis.html?partner=rss&emc=rss