Nov. 16--CHICAGO -- A new anti-clotting drug proved to be as effective as warfarin in preventing strokes in people with a common type of irregular heartbeat known as atrial fibrillation.
If approved by the FDA, rivaroxaban would give doctors another alternative to warfarin, which has been used for more than 50 years but is difficult to administer and can cause major bleeding.
Last month the FDA approved another warfarin alternative, Pradaxa, for preventing strokes in atrial fibrillation patients, who number about 2.5 million in the United States.
People with the condition are at four to five times greater risk of having a stroke.
The new drugs could be beneficial to hundreds of thousands of them who have trouble staying on warfarin, which requires regular blood tests and diet restrictions because of the potential for serious bleeding.
The study of rivaroxaban, which was funded by the drug's maker, Johnson & Johnson, involved 14,264 patients in 45 countries. It was presented at the American Heart Association's annual meeting.
The study involved a high-risk group of patients whose average age was 73 and who had a variety of other conditions such as heart failure, diabetes and high blood pressure. There were 269 strokes and blood clots in the rivaroxaban group and 386 in the warfarin group, although the difference was not considered statistically significant.
In addition to being as effective in preventing strokes, it was similar in overall bleeding complications and produced less bleeding in the brain.
While warfarin has been the main anti-clotting drug on the market since the 1950s, "no one could beat it," said Robert Califf, the study's lead investigator and vice chancellor for clinical research at Duke University School of Medicine.
"It was like the battered old boxer who kept winning."
With rivaroxaban, Califf said, there now is a drug that can be taken once a day without monitoring that is at least as good as warfarin with no increased risk.
Doctors not associated with the study said the two new drugs will have a big impact on the practice of medicine.
"This is an exciting finding," said Elaine Hylek, a physician and researcher at Boston University School of Medicine who was not involved in the study.
Raymond Gibbons, a cardiologist with the Mayo Clinic, said rivaroxaban will be a valuable alternative to warfarin, although there will be no need to switch patients off warfarin if they are doing well on it.
He said some doctors will be tempted to use the two new drugs in unapproved or so-called off-label applications such as in patients who have artificial heart valves or stroke patients who don't have atrial fibrillation.
He cautioned against such use.
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