Archive for the ‘Warfarin’ Category

Dabigatran approved!

October 21, 2010

For the first time in nearly 50 years, patients with Atrial Fibrillation (A-Fib) have a new blood thinning option: Dabigatran. The talk is already starting about how this could replace Warfarin (which is really RAT POISON… we’re just given it in doses too small to kill us!)

One can hope, but there is still a lot that we need to learn about the drug. The US Food and Drug Administration has approved it only as a preventive for stroke caused by A-Fib. Will it even work for anything else? The odds are that it will, but it still needs to be tested. How are people with mechanical valves going to react to it? Somebody’s going to have to take a deep breath and test it. Yet another problem is the cost. Dabigatran is estimated to cost $8 to $12 per day; Warfarin has been around so long that the cost is a pittance. But that is just the cost of the drug – with Warfarin, you also get the required monitoring, in the form of the INR Test. Dabigatran doesn’t require monitoring. Does the cost of Warfarin plus the cost of the test plus supplies make its cost roughly equal with Dabigatran?

There’s another major drawback for certain CHDers: Dabigtran is currently not recommended for “patients with the presence of a severe heart-valve disorder.” That sounds like Tricuspid Atresia patients, Hypoplastic Left Heart Syndrome patients, and those with several other defects are out of luck. Perhaps it is not for us because of lack of testing; if that is the case, the recommendation may change in the future.

At the moment, Dabigatran looks like a drug with a limited potential. Hopefully real world experience will change this.

“Low Sodium” Salt – coming soon!

March 24, 2010

A big announcement came out of a PepsiCo investors meeting yesterday – the company is working on a “Low Sodium salt.” Now I know a bunch of my readers just shouted “There ain’t no such thing!” at their computer screen, so I will try to explain.

PepsiCo’s new salt is designed differently. When you eat a potato chip, only 20% of the salt (if it is “normal salt”) dissolves on your tongue and gives you the salty taste. You chew and swallow before the rest of the salty flavor has a chance to kick in.

PepsiCo’s new salt is shaped and sized to allow more of the salt to dissolve in your mouth – consequentially, they can use less of it. This is also a part of PepsicCo’s plan to cut the amount of sodium in its food products by 25% over the next 5 years. The new low-sodium salt chips will be introduced in a few days.

This could be great news for those of us with Congestive Heart Failure (CHF). When the doctor tells you that you have Heart Failure and puts you on a low sodium diet, the snacks go out the window… at the very least, they have to become an occasional treat. A very occasional treat. Perhaps now we can have a chip or two without worrying if we are bumping into our daily sodium limit.

But this is Pepsico’s newest Secret Weapon (not only against Sodium, but all the other snack producers) so we don’t know what is in their formula. If it contains a lot of Potassium Chloride (a popular “Salt Substitute”, just replace the Sodium Chloride with Potassium Chloride) then it won’t do CHF patients any good. Potassium can affect any number of our drugs. And if you are on Warfarin, then you really need to avoid Potassium Chloride. Potassium is Vitamin K, which causes blood to clot. Warfarin reduces the ability of the blood to clot, and the two substances almost cancel each other out.

Reducing your salt intake is a good choice, especially if you have Heart Failure. It remains to be seen if the new “Low-Sodium Salt” is a step in the right direction or much ado about nothing.

A Replacement for Warfarin?

March 22, 2010

A lot of people dislike Warfarin. Also known by its brand name Coumadin, it is the most prescribed anticoagulant (Blood thinner) in North America. If you can get past the fact that you are taking something that is also used as rat poison, the constant monitoring and dosage adjustments are a pain in the butt. Every six weeks you must have a blood test, and it reacts with nearly everything. Other medications and even your choice of foods can make the drug more or less effective. This requires you to adjust your medication and have another blood test. It’s enough to make you yell!

But there are two new anticoagulants being developed that could replace Warfarin. The first is Dabigatran, which is marketed in Europe as Pradaxa. Dabigatran was approved for use in Europe and Canada in 2008 and is currently being considered here in the United States by the Food and Drug Administration.

Dabigatran has all the appearances of a wonder drug. It has done well in scientific studies: the RE-LY clinical trail shows that it performs better than Warfarin at some dosage levels; the RECOVER study proves that there is no need for the constant monitoring and no food/drug interactions.

If you’re waiting on the other shoe to drop, here it comes: Dabigatran is expensive. Great Britain’s National Health Service pays £4.20 per day for Dabigatran, and about £1 per day for Warfarin.

Ugh. Now that’s a problem.There are several theories that the cost difference can be recouped not only through the savings in monitoring costs, but the costs associated with stroke recovery. The simpler a medical therapy is to use, the more likely someone is to follow the instructions and benefit from it. Warfarin is difficult to maintain, while Dabigatran wouldn’t be. Just take your pill and go about your business.

The other new drug is Betrixaban, which is still being developed. It’s a joint venture between Merck and Co. and Portola, and like Dabigatran requires no monitoring and has almost no interactions. But it is still in Phase 2 testing, a long way from public use. Also, Portola is developing an “off switch”; another drug that can be administered in case of a heavy bleed and deactivate Betrixaban.

The potential market for any company that can develop a Warfarin replacement that has less interaction and less monitoring needs is wide open. Hopefully market forces will not only benefit the companies developing new drugs, but those of us who rely on them.