Rat Poison Alternative Cuts Clots; Approach to Benefit Millions
Warfarin users now undergo monthly blood tests to make sure they get the correct amount of the drug, since levels in the body react to numerous other medicines, alcohol and food ranging from beef to broccoli. Too little increases the risk of deadly clots, while too much triggers bleeding. Researchers said they have looked for something better for the past five decades, and have only now found something they agree is superior.
The change stems from findings of the largest study ever conducted in atrial fibrillation, an erratic heartbeat that predisposes patients to strokes and early death. It showed Boehringer Ingelheim Gmbhs Pradaxa is easier to take and offers either a 34 percent reduction in stroke or 20 percent fewer episodes of bleeding, depending on the dose. The drug is the first in a wave of new treatments doctors say will overhaul care for more than 7 million people worldwide.
“Its becoming a new era in stroke prevention and warfarin will be dead,” said Freek Verheugt, professor at the University Medical Center in Nijmegen, the Netherlands, in an interview. Pradaxa “raises the bar. The lack of bleeding was remarkable.”
The study of 18,113 patients, dubbed RE-LY, found the risk of bleeding in the brain, one of the most feared complications of warfarin, was reduced 69 percent to 74 percent in the Pradaxa group. Patients getting the drug also had fewer cases of life- threatening bleeding. The benefits came without signs of liver damage, a side effect that doomed AstraZeneca Plcs similar treatment Exanta.
Superior Results
The research, simultaneously published in the New England Journal of Medicine, was originally designed show Pradaxa was equal to warfarin. The superior results may affect the way millions of people are treated, researchers said.
“When this is available, we are going to turn to it in droves,” Chris Cannon, a cardiologist with Brigham and Womens Hospital in Boston, said in an interview, predicting the change will occur quickly. “This is a huge change and probably is the beginning of a total revolution. Having something that is easier is a game changer to begin with, but to have something thats better on efficacy and safety and easier is almost unbelievable.”
Additional studies are needed to make sure the drug is also effective in other patients, such as those with mechanical heart valves and a history of blood clots, doctors said.
Regulatory Approval
Closely held Boehringer of Ingelheim, Germany, plans to file for regulatory approval of the drug, which would be given as a pill twice daily based on weight, and expects to be able to sell Pradaxa by the end of next year, Chief Executive Officer Andreas Barner said in a telephone interview.
“If I had been asked to predict the most favorable result possible for this study, I couldnt have imagined showing such a result,” Barner said. “This is really good news for patients. This is really a once-in-a-lifetime thing.”
Pradaxa and Xarelto, a rival from Bayer AG and Johnson & Johnson, are both approved in some European countries. The U.S. Food and Drug Administration failed to clear Xarelto earlier this year for patients undergoing hip and knee replacement surgery, though the companies plan to submit additional data in the next few months to back the application. A study in patients with atrial fibrillation is expected next year.
New Drugs
Merck & Co. also is working on a rival to Pradaxa known as betrixaban that it licensed from Portola Pharmaceuticals Inc. in July. The drug is in the second of three stages of testing. Tokyo drugmaker Daiichi-Sankyo Co. also has a similar product in late-stage testing.
“Fortunately there are several other drugs coming along as well,” Cannon said. “Were all really looking forward to having rivaroxiban as an option as well,” he said, using the chemical name for Xarelto.
The number of patients with atrial fibrillation getting treatment may double because the new pills are so much easier to take, doctors said. More than half of the patients currently choose not to take warfarin because of the difficulty with using it or doctors concerns about the potential bleeding risks.
Cost will be an issue when it comes to the new medications, as they are expected to have price tags dramatically higher than warfarin.
Pradaxas Price