Post marketing study of Actos shows no increased risk of Bladder Cancer in Diabetes patients-Takeda

Takeda has announced the completion of the post-marketing commitment and submissions of data from a 10-year epidemiology study to regulatory authorities including the FDA, EMA and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for pioglitazone containing medicines, including Actos (pioglitazone HCl). This study was conducted by the University of Pennsylvania and Division of Research at Kaiser Permanente Northern California, and was designed to investigate whether patients exposed to pioglitazone were at an increased risk of bladder cancer. Findings demonstrate that there is no statistically significant increased risk of bladder cancer among patients ever exposed to pioglitazone.

Additionally, no association was found between the risk of bladder cancer and the duration of pioglitazone use, increased cumulative dose of pioglitazone or the time since initiating pioglitazone. In the five-year interim analysis published in Diabetes Care, a statistically significant increased risk among patients who used pioglitazone for two or more years was observed. However, the 10-year final analysis did not show any statistically significant findings of increased risk of bladder cancer with long term use of pioglitazone. The data will be shared with additional regulatory authorities in accordance with local requirements around the world, and final results will be submitted for publication in 2014.