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Published on 1 September 2014

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Takeda to submit data for pioglitazone containing medicines including ACTOS

Takeda Pharmaceutical Company Limited announced the completion of the post-marketing commitment and submissions of data from a 10-year epidemiology study to regulatory authorities including the United States (U.S.) Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for pioglitazone containing medicines, including ACTOS (pioglitazone HCl).(1,2)

Takeda Pharmaceutical Company Limited announced the completion of the post-marketing commitment and submissions of data from a 10-year epidemiology study to regulatory authorities including the United States (U.S.) Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for pioglitazone containing medicines, including ACTOS (pioglitazone HCl).(1,2)

This study was a 10-year epidemiology study, conducted by the University of Pennsylvania and Division of Research at Kaiser Permanente Northern California (KPNC), and was designed to investigate whether patients exposed to pioglitazone were at an increased risk of bladder cancer.(1) Findings demonstrate that there is no statistically significant increased risk of bladder cancer among patients ever exposed to pioglitazone.(2)

The primary analysis found no association between the use of pioglitazone and the risk of bladder cancer.(2) 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.

Commenting on the results, Dr Bob Ryder, Consultant in Diabetes, City Hospital, Birmingham said “The diabetes community has been anticipating the results from this study and we are pleased to see that there is no increased risk of bladder cancer with long-term use of pioglitazone”. He continued “Pioglitazone is a valuable treatment to have in our armory and therefore these results are reassuring for clinicians who prescribe the treatment for their patients”.

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.(1) 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.(2) 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.

“The completion of this long-term study is a milestone in the history of pioglitazone,” said Tom Harris, head, global regulatory affairs, Takeda. “The results of the study provide reassurance with regard to the use of pioglitazone and the risk of bladder cancer and further support the positive benefit risk profile of the product.”

  1. Lewis, JD et al. The Risk of Bladder Cancer Among Diabetic Patients Treated with Pioglitazone: Interim Report of a Longitudinal Cohort Study. Diabetes Care 24, April 2011 34:4 923-929.
  2. Takeda Data on File. 2014.


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