Today marks the beginning of FDA hearings on Avandia (rosiglitazone), a popular drug for diabetes. The hearing centers on whether Avandia places a patient at higher risk of a heart attack.
Patients taking Avandia may not realize that one of the primary reasons doctors use Avandia is not only to lower one’s blood sugar, but to thereby prevent heart attacks. Thus the question is highly relevant for every diabetic taking this medication.
There is no question that Avandia lowers blood sugar – that is easily proven. The blood glucose-lowering effects can be demonstrated over the course of weeks and months, with evidence of on-going decrease in blood sugar levels for years. And since it is well known that high blood sugar (diabetes) is associated with increased risk of heart attacks, it is only logical that lowering blood sugar levels should decrease the risk of heart attack (myocardial infarction).
Yet this is not necessarily so. Might Avandia be doing something else as yet unidentified within the body? This is often the case with drugs. In fact, it has long been known that taking Avandia increases the risk of liver problems. That is why your doctor checks the liver enzymes in your blood frequently. In certain patients Avandia also causes fluid retention that in some cases is associated with congestive heart failure. Clearly, Avandia does do something in the body besides lower blood sugar, but the question remains, which is more dangerous: to take the medicine or not?
There are many medications on the market for diabetes. Of course, insulin is the prototype and some might think the final answer. But patients do not like to inject themselves and so a number of oral medicines have been developed. Also, taking insulin tends to cause weight gain in Type 2 diabetics, and since weight gain is a big part of the problem to begin with, to some degree it worsens the situation.
Knowing all this, should you stop taking Avandia? At this point the answer is we don’t know. Since the drug was released I have seen a very few patients suffer from excess fluid retention, but since that problem was recognized, the drug has not been advised for patients with swelling or heart failure. To date, only a few of my patients have had abnormal liver tests, and these have all been reversible with discontinuation of the drug. For my patients, Avandia has been effective at lowering blood sugars.
Yet the question remains, what about heart attacks? This week the FDA will be reviewing data from scientific trials regarding the use of Avandia (rosiglitazone), as well as health claims data related to its use. When all the information is gathered, statisticians and physicians will have more accurate information on which to make an informed decision. If we already knew the answer, the hearings would be unnecessary.
But what should you do in the meantime? Here is one way to think about the problem: if the answer has not become clear over 10 years of use in millions of patients, the risk cannot be extremely high and is unlikely to be an immediate danger. Therefore, you have time to discuss this with your doctor. It may well be that certain patients are at risk, whereas others are not. Identifying these subgroups may be the key. Simply stopping Avandia and allowing your blood sugar to run high is definitely not a smart move. If you are afraid of the drug, see your doctor to develop an alternative plan. If you have done well on Avandia and are hesitant to change medication, keep in mind that we don’t yet have proof of increased risk. Keep your eye on the news for analysis of the data, and talk with your doctor at your next appointment.
Copyright 2010 Cynthia J. Koelker, M.D.