Pill Works as Well Against Lung Clots as Injection

A new kind of blood thinner that comes in a pill form and is made by German drug giant Bayer works as well as injection therapy to ward off blood clots in the lungs, said a study on Monday.

Xarelto, or rivaroxaban, was tested in an international phase III clinical trial as a treatment to treat or prevent a recurrence of venous thromboembolism, the third most common kind of cardiovascular disease, which can strike the legs or the lungs.

Pulmonary embolism, or clots in the lungs, are third leading cause of death in US hospitals.

The trial of nearly 5,000 people in 38 countries found that the pill was easier to administer than the two-shot regimen of the anti-coagulant enoxaparin, followed by a vitamin K antagonist, which is the standard therapy.

It also appeared to be safer in terms of preventing major bleeding, said lead study investigator Harry Buller, professor of vascular medicine at the Academic Medical Center in Amsterdam.

"Rivaroxaban is just as good as standard treatment for PE (pulmonary embolism) -- these data are pretty convincing -- and this is an oral-only approach, which makes it very simple," he said in a statement.

All subjects in the study were diagnosed with pulmonary embolism, and a quarter also had leg clots.

Those in the pill group took the medicine by mouth twice a day for three weeks, then once a day for the rest of the study which lasted between three and 12 months as judged appropriate for various patients.

The other half, who were assigned to get the injections, had two shots daily of enoxaparin for five days, followed by vitamin K shots.

The findings could give doctors an easier way to treat patients and reduce office visits, even though the standard injection therapy is considered effective and works against thrombosis almost 90 percent of the time.

"The reason people look for alternatives is that it's a nightmare to give. Rivaroxaban makes things easier for everybody -- patients and physicians," said Buller.

"Physicians want to know about major bleeding, the most important safety outcome, and rivaroxaban was highly significantly superior. This was our most astonishing finding."

Rivaroxaban has been approved by US regulators for preventing clots in patients who have knee or hip replacement surgery.

The latest data from the trial, known as EINSTEIN-PE and sponsored by drug-makers Bayer and Janssen Pharmaceuticals, was presented at the American College of Cardiology conference in Chicago.

More details also appear in the New England Journal of Medicine online.