Should I stop my diabetes medicine? FDA Hearings to Determine Heart Attack Risk

Today marks the beginning of FDA hearings on Avandia (rosiglitazone), a popular diabetes medication. The hearing focuses on whether Avandia puts a patient at increased risk of a heart attack.

Patients taking Avandia may not realize that one of the main reasons doctors use Avandia is not only to lower blood sugar, but also to avoid heart attack. Therefore, the question is very relevant for all diabetics taking this drug.

There is no doubt that Avandia lowers blood sugar, that is easily proven. Blood glucose lowering effects can be demonstrated over the course of weeks and months, with evidence of continued decline in blood sugar levels for years. And since it is well known that high blood sugar (diabetes) is associated with an increased risk of heart attacks, it stands to reason that lowering blood sugar levels lowers the risk of heart attack (myocardial infarction). myocardium).

However, this is not necessarily so. Could Avandia be doing something else as yet unidentified within the body? This is often the case with drugs. In fact, taking Avandia has long been known to increase the risk of liver problems. That’s why your doctor often checks the liver enzymes in your blood. In some patients, Avandia also causes fluid retention which, in some cases, is associated with congestive heart failure. Clearly, Avandia does something in the body besides lowering blood sugar, but the question remains, which is more dangerous: taking the drug or not?

There are many medications on the market for diabetes. Of course, insulin is the prototype and some might think it’s the final answer. But patients don’t like to inject themselves, so various oral medications 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 some extent it makes the situation worse.

Knowing all this, should I stop taking Avandia? At this point, the answer is that we don’t know. Since the drug was launched, I have seen very few patients suffer from excessive fluid retention, but since that problem was recognized, the drug has not been recommended for patients with swelling or heart failure. To date, only a few of my patients have had abnormal liver tests, and all have been reversible with discontinuation of the medication. For my patients, Avandia has been effective in lowering blood sugar levels.

However, the question remains, what about heart attacks? This week, the FDA will review data from scientific trials on the use of Avandia (rosiglitazone), as well as data from health claims related to its use. When all the information is collected, statisticians and doctors will have more accurate information 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’s one way to think about the problem: If the answer hasn’t been clear over 10 years of use in millions of patients, the risk can’t be extremely high, and it’s unlikely to be an immediate danger. Therefore, you have time to discuss this with your doctor. It may well be that some patients are at risk while others are not. Identifying these subgroups may be the key. Simply stopping taking Avandia and allowing your blood sugar level to rise is definitely not a smart move. If you are afraid of the medicine, consult your doctor to develop an alternative plan. If you’ve done well with Avandia and are hesitant to switch, keep in mind that we don’t yet have evidence of an increased risk. Keep an eye on the news for data analysis and talk to your doctor at your next appointment.

Copyright 2010 Cynthia J. Koelker, MD

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