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news.Takeda Pharmaceutical (Takeda) has completed the post-marketing commitment and submissions of data from a 10-year epidemiology study to regulatory authorities including the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the Japanese Ministry of Health, Labour and Welfare (MHLW) / Pharmaceuticals and Medical Devices Agency (PMDA) for pioglitazone containing medicines, including ACTOS (pioglitazone HCl).
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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.
Findings demonstrate that there is no statistically significant increased risk of bladder cancer among patients ever exposed to pioglitazone.
The primary analysis found no association between the use of pioglitazone and the risk of bladder cancer. 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.
"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."
Pioglitazone is approved as an agent to treat patients with Type 2 diabetes mellitus in more than 100 countries world-wide. More than 27,000 subjects have been included in clinical trials, and globally the total patient-years of exposure since first launch (1999) is estimated to be in excess of more than 29 million. Pioglitazone as a treatment of Type 2 diabetes mellitus at the recommended doses provides a valuable treatment option, and has a well established safety profile.
The benefits of good glycaemic control associated with Type 2 diabetes mellitus outweigh the risks associated with therapy which are appropriately communicated and managed by the current product labelling.