Actos and Competact (out of France)

Summary of the study conducted by the National Health Insurance

Risk of bladder cancer in people with diabetes treated with pioglitazone in France: a cohort study on data from the PMSI and SNIIRAM

This is the largest study on this subject. Its main objective is to specify, in people with diabetes treated in France, the existence of a possible link between exposure to pioglitazone and the risk of developing cancer of the bladder.

This study was conducted on a cohort of 1,491,060 patients with diabetes treated with specific drugs, aged 40 to 79 years. It covers a period from 2006 to 2009.

The group exposed to pioglitazone included 155 535 people with diabetes and the unexposed group 1,335,525 people with diabetes.

Analysis of this cohort of diabetic patients followed in France between 2006 and 2009 the hypothesis of the existence of a statistically significant association between exposure to pioglitazone and incidence of bladder cancer.The observed results are similar to those obtained in the United States on the cohort of Kaiser Permanente Northern California.

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