Increased Risk for Macular Edema 5X with a TZD

Treating type 2 diabetic patients with pioglitazone, a thiazolidinedione, significantly increased the risk for macular edema....

For those patients who received the thiazolidinedione (TZD), the risk for macular edema was 5 times greater than in those who did not receive pioglitazone.

In addition, combining pioglitazone with insulin was associated with an even greater risk for macular edema, with patients having a more than 11-fold increased risk compared with diabetic patients who did not receive the 2 drugs.

The results, presented last week at the European Association for the Study of Diabetes (EASD) 2013 Meeting, are from a retrospective cohort analysis of patients with type 2 diabetes and no history of macular edema treated at a single center in Japan.

The study was led by Kanta Fujimoto, MD, from the Tazuke Kofukai Medical Research Institute, Kitano Hospital, Osaka, Japan. Presenting the results the lead researcher, Kanta Fujimoto, MD., said several studies have highlighted the adverse effects of pioglitazone, particularly several analyses that have suggested an increased risk for bladder cancer with the drug. Other studies have suggested pioglitazone causes fluid retention, and this can increase the risk for macular edema, said Fujimoto.

These studies, however, have been limited by missing data, particularly information about confounding variables, such as the presence/absence of renal and heart failure. Both renal and heart failure are often associated with diabetic macular edema, he said.

Between 2000 and 2012, there were 22,115 patients with type 2 diabetes treated at Kitano, Japan Hospital. Of these, 953 were treated with pioglitazone. The pioglitazone-treated patients were sicker than those not treated with pioglitazone and were significantly more likely to be treated with insulin, have renal failure, have congestive heart failure, be treated with ACE inhibitors and antiplatelet medications, and have higher HbA1c levels.

For those who received insulin and pioglitazone, the 12-year adjusted hazard ratio for macular edema was 11.86 (95% CI, 4.70–29.93) when compared with patients not treated with pioglitazone or insulin.

Not surprisingly, Fujimoto called for further large-scale studies to address this particular safety signal in type 2 diabetic patients treated with the thiazolidinedione.

Practice Pearls:

There was no adjustment in the model for body mass index (BMI).

Patients treated with pioglitazone have typically failed to lower HbA1c levels with metformin and tend to be obese and have more insulin resistance.


How many times and for how many years have we said, drugs are not the answer for controlling type two diabetes. Change your lifestyle and that means drop the carbs and live with nil or minimal medication.


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