MONDAY, Dec. 7 (HealthDay News) A new blood thinner called dabigatran etexilate may be just as effective in preventing dangerous venous clots as an old standby, warfarin, but much easier for doctors and patients to manage, a new study finds.
Dabigatran is marketed as Pradax in Canada and Pradaxa in Europe; it is not yet approved for use in the United States.
The new study, published early online Dec. 6 by the New England Journal of Medicine, follows on the heels of two other promising reports presented at the American Heart Association meeting in Orlando, Fla., last month. Those studies found that dabigatran appeared safe and effective in preventing blood clots when patients were treated for acute coronary syndrome, a cluster of symptoms that might indicate a heart attack; it was also found superior to warfarin in preventing strokes in patients with the irregular heartbeat known as atrial fibrillation.
In the new trial, warfarin and dabigatran seemed to perform equally well in helping patients with potentially dangerous clots in their veins avoid a subsequent clot or death over the next six months.
But it is in its ease of use that the newer drug appears to outshine warfarin, the authors of this latest study say.
Doctors have for years been looking for a safe alternative to warfarin, which is notoriously difficult to manage.
"For patients and health-care providers, dabigatran is a far more convenient drug than warfarin because it has no known interactions with foods and minimal interactions with other drugs and therefore does not require routine blood-coagulation testing," wrote the international team of researchers led by Dr. Sam Schulman of McMaster University and the Henderson Research Center in Hamilton, Ontario, Canada.
In the prospective trial, which was funded by dabigatran's maker, Boehringer Ingelheim, nearly 1,300 patients who had experienced a venous thromboembolism (VTE) received 150 milligrams of dabigatran in pill form twice a day. Another group of almost 1,300 patients was given warfarin, adjusted in dose to suit their particular needs.
Six months after the therapies began, 30 patients on dabigatran experienced another VTE compared to 27 patients on warfarin, for a 0.4 percent difference in risk, the authors report. Side effects such as major or minor bleeding were similar between the two groups, with slightly more bleeding events occurring in those on warfarin.
Based on the results, the authors conclude that, "a fixed dose of dabigatran is as effective as warfarin, has a safety profile that is similar to that of warfarin, and does not require laboratory monitoring."
Those optimistic findings echo those from the American Heart Association meeting in November. That study involved more than 1,800 patients in 24 countries with acute coronary syndrome -- a cluster of symptoms that might indicate a heart attack. Patients received one of four doses of dabigatran or a placebo on top of aspirin and the blood thinner Plavix.
The study found dabigatran safe in preventing blood clots in these heart patients. Researchers also saw reductions in mortality, nonfatal heart attack and stroke, although the trial was not specifically designed to look at efficacy.