Takeda announced their completion and data submission of a 10-year epidemiology study to regulatory authorities, including the United States Food and Drug Administration (FDA).
The 10-year study aimed to evaluate whether patients exposed to pioglitazone were at an increased risk of bladder cancer. Study findings showed there was no statistically significant increased risk of bladder cancer among patients ever exposed to pioglitazone. In addition, no link was found between the risk of bladder cancer and the length of pioglitazone use, increased cumulative dose, or the time sine initiating pioglitazone.
An initial 5-year interim analysis had demonstrated a statistically significant increased risk among patients who used pioglitazone for >2 years. However, the 10-year analysis did not show any statistically significant findings of this increased risk.
Pioglitazone (marketed as Actos; Takeda) is a thiazolidinedione indicated as adjunct to diet and exercise in type 2 diabetes, as monotherapy or in combination with metformin, insulin, or a sulfonylurea.
Final results of the study will be submitted for publication in 2014.
For more information visit Takeda.com.