Successful Trial of Rivaroxaban ....

[Jkm7]

I just read this at iVillage...... Have no idea how reliable but it sure sounds hopeful.

New Anti-Clotting Pill Works Well in Trials
June 25 (HealthDay News) -- A new anti-clotting drug that could be one of the long-sought alternatives to commonly used blood thinners has performed well in hip and knee replacement patients, physicians report.

The drug, rivaroxaban, was more effective at reducing potentially fatal blood clots than heparin, with no increase in side effects, according to studies by three research teams reporting this week in the New England Journal of Medicine and The Lancet.

"It was superior to low molecular weight heparin, one of the two most common prophylaxis modalities in the United States," said Dr. William Geerts, a professor of medicine at the University of Toronto, and a member of a team that tested rivaroxaban after hip replacement surgery.

Prophylaxis in this case means prevention of blood clots. Heparin is commonly used in hospitals because it is easier to manage than Coumadin (warfarin), which requires frequent blood tests for close control. The new drug, rivaroxaban, is an easily swallowed pill that does not require constant monitoring.

In the international trial of 4,541 people who had hip surgery, 1.1 percent of those given rivaroxaban suffered problems such as deep-vein blockage or pulmonary embolism, compared to 3.7 percent of those given enoxaparin, a widely used form of heparin. The incidence of major bleeding was similar in both groups -- six of 2,209 for rivaroxaban, and two of 2,224 for enoxaparin.

In the knee replacement study, which included 2,531 patients, 9.6 percent of them given rivaroxaban experienced problems such as deep-vein thrombosis, compared to 18.9 percent of those who got enoxaparin.

The third study, done in England, followed 2,509 people who had hip replacement surgery for more than a month after they left the hospital. Only 2 percent of those taking rivaroxaban suffered problems during that time, compared to 9.3 percent of those getting daily injections of heparin.

All three studies were funded by Bayer, which plans to market the drug rivaroxaban as Xarelto. It already has competition from another anti-clotting drug known as dabigatran, which the pharmaceutical company Boehringer Ingelheim has permission to market in Europe and has approval to start marketing in Canada later this month, Geerts said. The brand name of that pill is Pradaxa.

The potential bigger market for both new anti-clotting drugs is for out-of-hospital use. An estimated 2 million Americans now take -- or are supposed to take -- Coumadin because of atrial fibrillation, the abnormal heartbeat that can cause formation of life-threatening blood clots, said Dr. Richard C. Becker, a professor of medicine at Duke University Medical Center, who co-wrote an accompanying editorial in the New England Journal of Medicine. Bayer is moving toward marketing rivaroxaban for those people, he said.

"These trials are part of a very large program," he said. "There are four large trials in orthopedic surgery and also large programs in atrial fibrillation. There are also programs for patients with acute coronary syndrome. In all, there will be close to 50,000 patients in randomized clinical trials."

Both new anti-clotting pills will be an improvement for many people now taking Coumadin, Geerts said. Because of the frequent testing required for Coumadin, many people who are told to take the medication don't follow instructions, he said. "This will likely translate to a larger proportion of people who should be on prophylaxis actually getting it," he said.

But the fact that frequent tests aren't required for the new anti-clotting agents is a challenge to physicians, Geerts said. Lab tests are proof-positive that someone is taking their medicine, he said. "As physicians, we have to think of new strategies to make sure people are compliant," he added.

 

[Ross]

Nice but not one mention of valve replacement patients.

 

[Jkm7]

True, Ross. But one step at a time. If they find success with hip replacement patients and a-fib patients, who can say that valvers won't possibly benefit as well? At some point if these drugs continue to show such promise, perhaps valvers will be considered.

 

[Ross]

I wish I had that much faith in them, but I don't.

 

[Guest]

My take on warfarin replacements

My take on warfarin replacements

1. The last article I read was that they put vales in several sheep (maybe pigs - I'm not sure which was the latest) and re-routed their blood to flow through the kidneys as soon as it left the heart. After about 30 days they killed the animals and looked for clots in the kidneys and weighed them. That was the baseline to get ready to repeat the experiment but this time giving one of the warfarin replacements to some and warfarin to others. That way they have proof that the drug reduced the amount of clot. At this stage testing on humans is usually several years away.

2. Exanta, the last drug that was going to replace warfarin, got down to the "champagne on ice" stage because the FDA was going to approve it that day. (I testified at the hearing.) But the FDA did not approve it because it caused liver toxicity that could not be predicted. One man had his liver function tests and was to repeat them 30 days later. At 29 days he suddenly died from liver failure. They used 60 different treatments to try to save his life but nothing worked.

3. The new drugs are going to be expensive. My guess is about $5 per tablet. This will put them in the highest category on many insurance co-pays.

4. We know that warfarin is fairly non-toxic to the liver etc because we have 60 years of experience with it.

5. The FDA is likely to require liver testing every 30 days even if the test is not a good predictor of liver failure.

6. We will not know for many years whether the drug causes less bleeding than warfarin in long-term, real-life use.

7. Each person will have to make the decision for themselves as to the risk-benefit balance.