Diabetes Forecast

Worried About Actos

I was diagnosed with diabetes one year ago and was placed on Actos. I am concerned about continuing on Actos based on all I read and have not tried any other treatment. Should I be concerned, and would you recommend other treatments? Mike Petrunic

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Craig Williams, PharmD, responds: Many readers will be aware of the recent controversy surrounding the "glitazone" drugs, rosiglitazone (Avandia) and pioglitazone (Actos). The controversy began with an analysis that looked back at about 40 mostly smaller studies with rosiglitazone and determined that there was a small but significant increased risk of heart attack with that drug. To put it in some perspective, there was about one extra heart attack for about every 2,000 patients treated for a year with rosiglitazone. So far, similar analyses with pioglitazone have not found the same risk, and a large, randomized trial of pioglitazone completed in 2005 actually found a small reduction in the risk of heart attacks. As a result, the U.S. Food and Drug Administration recently put a warning on the label for rosiglitazone and not pioglitazone cautioning about the risk of heart attack. However, many clinicians and researchers remain skeptical that the risk from rosiglitazone is significant, and the FDA left it on the market because it feels the benefits still outweigh the risks for many patients.

There are some real limitations on the data that was available for the analysis that showed the risk with rosiglitazone, and in 2007 a large, randomized trial of nearly 4,500 patients taking rosiglitazone for nearly 4 years failed to find an increased risk of heart attack compared to sulfonylureas and metformin. But while the controversy continues, do not forget that the risk of poorly controlled hyperglycemia is quite clear, so no one should stop taking glucose-lowering medications without consulting their primary care provider. Also, there is already a well-known risk with both agents among patients with heart failure. None of the recent controversy has lessened that concern.

So in regard to the specific question of pioglitazone, the data to date has not found any increased risk of heart attack and it can and should remain a part of a comprehensive diabetes management strategy for appropriate patients.



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