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Avandia gets its death certificate

For three years now, the once-promising diabetes medication rosiglitazone (Avandia) has been waiting for the axe to fall. Sales plummeted after a linked the drug to a sharply increased risk of heart attack.

Since then, re have only confirmed that rosiglitazone increases heart attack risk in diabetic patients by 30 to 80%. Equally damning was data showing that this is not a class effect common to the thiazolidinediones - in fact rosiglitazone’s direct competitor pioglitazone has a fairly good cardiovascular risk profile.

Many diabetologists have suggested that rosiglitazone remains a useful option in reducing glycemia, so long as it’s used with care, and only in patients without heart problems. But pioglitazone’s better showing really kicks the last leg out from under this argument. Rosiglitazone delivers nothing that pioglitazone doesn’t, except for extra cardiovascular risk.

Rosiglitazone has had a Health Canada warning in its monongraph since 2007, issued a few weeks after the FDA gave it one of their notorious “black box” warnings. Its indications for use were also tightened considerably. Since then, sales have fallen by about two-thirds. The end has been drawing near, and this time, Health Canada beat the FDA to the punch.

From now on, the drug will only be prescribed in Canada if patients sign a consent form acknowledging that they’re aware of added dangers of heart attack, angina and heart failure, plus unspecified “other risks”. The patient must also certify their awareness that “there are other options to treat my diabetes.”

The physician, meanwhile, is enjoined not to use rosiglitazone-containing products except in cases when “all other oral antidiabetic agents, in monotherapy or in combination, do not result in adequate glycemic control or are inappropriate due to contraindications or intolerance.”

So farewell, then, Avandia. Neither patient nor physician is likely to go along with that, especially when there’s a boatload of promising new diabetes drugs hitting the market. Drugs whose hidden pitfalls, if any, have yet to be revealed.

What lesson may be gleaned from all of this? One reason rosiglitazone’s dangers went unnoticed for so long is that, while the drug brought much more cardiovascular risk than placebo, the effect was less noticeable when compared to other antihyperglycemic drugs like sulfonylureas and even the reliable standby metformin - because all of these drugs also increase the risk of lethal heart problems.

It may seem odd that, when cardiovascular disease is the thing most likely to kill diabetic patients, we routinely treat diabetes with drugs that increase the risk of cardiovascular disease. It seems even odder when we consider that there’s a safe, cost-free way to reduce blood sugar that actually improves cardiovascular health … that is, exercising and eating a healthy diet of low glycemic index foods.

Oddest of all, surely, is the fact that so many patients are apparently more comfortable with the idea of popping multiple pills with potentially grim side effects than they are with the idea of eating a few more vegetables and a bit less ice cream.
Owen Dyer