A win for a new drug

It’s not often that drug studies are stopped early because of success.  Usually they are stopped early because of either a structural problem in the protocol or for reasons of safety.  Lately, studies stop because the companies have gone bankrupt.

Apixaban is a drug that we are studying and our study continues in follow-up.  A sister study done was stopped because the drug proved significantly more beneficial and it was no longer ethical to proceed.

This drug is one of several in development of a new class of drugs.  These compounds are known as factor xa inhibitors.  They block the clotting cascade at a different point than Coumadin and are going “head to head” against Coumadin in many studies.  One is close to approval in the US and is being presented to the FDA for final approval next month.

The use of these drugs will be felt most in the treatment of atrial fibrillation.  As I have blogged about many times, atrial fibrillation is increasing in prevalence as our population grows older and about 10% of people over the age of 80 are affected by it.  The big problem with atrial fibrillation is the strokes that occur.  If no anticoagulation is given, the risk of stroke is 5% a year.  If patients take Coumadin the risk is cut to 1%.  It is not perfect.  Coumadin however becomes more and more difficult to take as patients get older and comes with many restrictions.  These new drugs do not as yet have important drug interactions (I can assure you there will be some) and have no dietary interactions like Coumadin does.  The one drawback of the drug is that it must be taken twice a day.

The study reported concerned those patients that can’t or won’t take Coumadin.  5,600 patients received either 5 mg of apixaban or aspirin in varying doses.  The study was stopped because, again, aspirin proved not effective in preventing strokes.  I should mention that Plavix and the combination of Plavix and aspirin have never been found to be effective either.

So, it will likely be that this drug will be an option for patients who will receive the benefit and sustain fewer side effects than taking Coumadin.  This is real progress and this drug is eagerly being awaited by both physicians and patients.  It will be a “blockbuster” drug for the company who gets approval first.  By the way, a “blockbuster drug” is one that brings in over a billion dollars a year.

Tags: Apixaban, atrial fibrillation, Coumadin, studies, xa inhibitors
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