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Pradaxa vs Warfarin in VTE

Boehringer’s Pradaxa Matches Warfarin as Clot Therapy in Study

http://www.bloomberg.com/apps/news?pid=20601202&sid=aikUAPjkYf6A

By Naomi Kresge

Nov. 23 (Bloomberg) -- Boehringer Ingelheim GmbH’s blood- thinning pill Pradaxa was as effective and safe as the standard therapy for potentially deadly clots, according to the results of a head-to-head study.

Just 2.4 percent of patients given Pradaxa for six months after their initial treatment developed clots in the legs and lungs, similar to the 2.2 percent rate for those given the generic drug warfarin, according to an abstract of the so-called Recover study posted on the American Society of Hematology Web site last week. There was no increased risk of major bleeding, a complication of blood-thinning treatments.

Unlike newer medicines like Pradaxa and Bayer AG’s Xarelto, warfarin requires regular checks to ensure patients are getting the right dose. Doctors are divided over whether to keep using warfarin for longer than six to 12 months because of the monitoring required and because it can increase the risk of fatal bleeding. Some 1.6 percent of patients who took Pradaxa in the Recover study experienced major bleeding, compared with 1.9 percent of those on the older drug.

The pill “is as effective and safe as warfarin,” researchers led by Sam Schulman, a professor in the department of medicine at McMaster University in Hamilton, Ontario, wrote in the abstract.

Researchers will present full results of the trial in which none of the 2,539 patients or their doctors knew which medicine was being given on Dec. 6 at the American Society of Hematology medical conference in New Orleans.

The Boehringer drug and Bayer’s Xarelto, co-developed by Johnson & Johnson, are approved in some European countries.