Anticlotting Drug May Be Alternate to Warfarin
Study Shows Xarelto May Prevent Stroke and Blood Clots
Nov. 15, 2010 (Chicago) -- The experimental anticlotting pill Xarelto works at least as well as standard warfarin at preventing stroke and blood clots in people with irregular heart rhythms from atrial fibrillation, researchers report.
The rate of major brain bleeds, a key concern, was lower among patients on Xarelto, says Robert Califf, MD, of Duke University in Durham, N.C.
Overall, the rates of bleeding and adverse events were similar among people taking Xarelto and those taking placebo.
If approved by the FDA, Xarelto will offer an alternative to the old standby warfarin, which many people can't or won't take, doctors say.
Xarelto vs. Warfarin
In the study, 1.7% of people taking Xarelto had a stroke or a blood clot in another part of the body, compared with 2.2% of those given warfarin.
When the analysis was adjusted to include people who stopped taking the drug or switched to another treatment before the trial was complete, 2.1% of those on Xarelto and 2.4% of those on warfarin had a stroke or a clot, a difference so small it could be due to chance.
Both ways of looking at the data have their pros and cons, Califf says. But either way, "we have a drug you can take once daily, without monitoring, that is at least as good as warfarin and carries no additional risks," he says.
As for safety, 55 patients taking Xarelto experienced "the more worrisome" brain bleeds compared with 84 on warfarin, Califf says. This translates to a 33% lower risk of getting a major brain bleed if you take Xarelto, he says.
People treated with Xarelto also had fewer critical organ bleeds and were less likely to die from a bleed, compared with those treated with warfarin. But they were more likely to have drops in hemoglobin or bleeds requiring transfusions, both of which are also considered major bleeds.
Patients on Xarelto were also slightly more likely to have minor bleeds such as nosebleeds, Califf says.
Xarelto was associated with fewer deaths -- 582 vs. 632 in the warfarin group -- but the difference could have been due to chance.
There was no evidence the new drug caused liver problems, which also had been a worry, he says.
The study involved 7,111 patients on Xarelto and 7,125 patients on warfarin.
Califf presented the findings at a news briefing at the American Heart Association meeting.