Dr. Giancarlo Agnelli, director of the department of internal and cardiovascular medicine and stroke unit at Perugia University Hospital in Italy, and his colleagues randomly assigned almost 2,500 patients to one of three regimens for a year.
Patients were either given 2.5 milligrams (mg) of apixaban twice daily, 5 mg of apixaban twice daily or an inactive placebo. Over the course of the trial, the researchers looked for recurrent venous thromboembolism, deaths from venous thromboembolism or cardiovascular problems and major bleeding.
The investigators found that either dose of apixaban reduced the risk of recurrent venous thromboembolism and venous thromboembolism-related death by about 80 percent, compared with placebo.
While almost 9 percent of those receiving placebo had one of these events, only 1.7 percent of those taking apixaban did, the researchers reported.
In addition, either dose of apixaban reduced the risk of stroke, heart attack and cardiovascular-related death. Major bleeding was similar for those taking apixaban and those receiving placebo, the researchers noted.
"These results indicate that apixaban -- at both low and high doses -- provides an attractive risk-benefit profile for use as an ongoing treatment option in patients at risk of recurrent [venous thromboembolism]," Agnelli said in a statement.
"This regimen has the potential to eliminate many of the challenges we face when we treat patients with warfarin -- including drug and food interactions and the need for ongoing monitoring -- which can greatly simplify ongoing management of this condition," he added.
The trial was funded by the developers of apixaban, Bristol-Myers Squibb and Pfizer. Although the drug has not yet been approved by the U.S. Food and Drug Administration, a decision is expected in March, according to th
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