The Flex Diet – It Bends, So You Don't Break.

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Phrases like “game-changer” or “magic bullet” are thrown around a lot in medical circles, when doctors and researchers dream about changes in the medications we use to treat our patients.  For example, one of the most elusive targets in our quest to prevent heart disease is a medication that will safely raise HDL cholesterol and reduce the risk of future heart attacks.  But score one for medical research with the recent FDA approval and cost-effectiveness analysis for Dabigatran.

Dabigatran is a medication designed to thin the blood and reduce the risk of blood clots and strokes in individuals with atrial fibrillation, a common heart rhythm disorder which affects millions of Americans.  In addition to concerns related to symptoms of palpitations or less efficient heart function with increased heart rates, atrial fibrillation can increase the risk of strokes considerably – particularly in people who are at baseline higher risk.  For years, we have used warfarin (also affectionately known as “rat poison”) to thin the blood and reduce stroke risk.  However, warfarin is a challenging medication to take.  It requires some dietary modifications and regular blood testing.  It takes several days to wash out of your system, which can be challenging in the setting of bleeding or the sudden need for surgery.

Previous attempts at a substitute for warfarin have been complicated by dangerous side effects.  So with recent FDA approval of Dabigatran for stroke prevention in individuals with atrial fibrillation, we at least have a base hit.  And with the newest data suggesting that Dabigatran may even be more cost-effective than warfarin, it’s looking more like a home run.

One of the challenges of introducing a new medication into the health care system is that being effective is only part of the picture.  If a new drug works well but will bankrupt patients, it’s not going to work out.  This is why a recent study from Stanford allows patients and physicians to breathe a sigh of relief.  Researchers decide that a medical intervention (medication, procedure, or treatment) if it costs less than $50 000 per quality-adjusted life-year (QALY) gained.  In the case of Dabigatran, the number falls somewhere in the neighborhood of $45,000.  This assumed a daily cost of about $13 for the medication, although it has been recently reported that wholesale price will actually be closer to $6.75 – this would make Dabigatran significantly more cost-effective than the recent study would suggest.  Grand slam?

As you can tell, I’m pretty excited about Dabigatran.  I have no relationship to the company that makes it, but do have hundreds of patients who take warfarin, many of whom ask me at every visit when there might be a safe and effective alternative.  It’s looking like the time has come.