Local scientists working on easier Coumadin alternative

September 2, 2009 8:53:04 AM PDT
For decades, Coumadin, sold generically, as warfarin, has been one of the most widely used drugs in the U.S.

It is used by millions of patients across the country after heart attacks and strokes, to keep their blood moving freely.

But it is a challenging drug for doctors and patients. Frequent blood tests are needed, and changes in dosages needed to keep blood the right consistency. Too little warfarin, and you risk a stroke; too little and you risk dangerous bleeding.

Today, a study released at the European College of Cardiology meeting, and published by the New England Journal, says another drug under development may be a good alternative.

The drug, called Dabigatran, is a twice-daily oral medication that doesn't require the frequent monitoring warfarin does. And in clinical trials, it didn't interact with foods or other medication.

The drug was developed by German pharmaceutical maker Boehringer Engleheim, and is being tested by the Lankenau Institute for Medical Research, located in Wynnewood, Pennsylvania, and at dozens of medical centers, including Lankenau Hospital.

Dr. Michael Eskowitz of the Lankenau Institute is the lead U.S. researcher.

The RE-LY trial a three-year study of 18,000 patients in 44 countries, focused on patients with atrial fibrillation. That's a condition in which the upper chamber of the heart gets out of rhythm with the lower chamber.

The irregular blood flow raises the risk of blood clots, and with it, stroke.

In the trial, Dabigatran went into effect within hours, compared to the 4 days warfarin requires to become effective.

Patients on it had fewer drug interactions, and reported fewer episodes of bleeding.

However, a significant minority of patients did experience heartburn. It was serious enough for some patients to stop taking Dabigatran.

And there was a small, but statistically significant, increase in heart attacks among Dabigatran users.

Doctors don't yet know what the most effective dose of Dabigatran is.

The FDA will want solid answers to these questions before it will approve Dabigatran.

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