Takeda PM study shows no link for pioglitazone and bladder cancer

Takeda Pharmaceutical (TYO: 4502), Japan’s largest drugmaker, says it has completed the study to fulfill the post-marketing commitment and submissions of data to regulatory authorities from the Pan European Multi-Database Bladder Cancer Risk Characterization Study, a large (n=112,674), multi-database retrospective matched cohort study, conducted in four European countries, for pioglitazone containing medicines, including Actos (pioglitazone HCI) with up to 10 years of follow-up.

Findings demonstrate that there is no association between the use of pioglitazone and the risk of bladder cancer, (hazard ratio [HR] 0.99 [95% CI: 0.75, 1.30]). These results are consistent with those of a 10-year, prospective cohort study, conducted by the University of Pennsylvania and Division of Research at Kaiser Permanente Northern California (KPNC), which demonstrated no increased risk of bladder cancer among patients ever exposed to pioglitazone ([HR] 1.06 [95% CI 0.89-1.26]).Additionally, both studies found no association between the risk of bladder cancer and cumulative dose of pioglitazone, or duration of pioglitazone exposure.

“ACTOS is an important treatment option for patients with type 2 diabetes. These data further reinforce the positive benefit/risk profile for ACTOS,” said Alfonso Perez, vice president, clinical research, at Takeda. “These long-term studies underscore Takeda’s commitment to ensuring physicians have the best available information to make treatment decisions,” Dr Perez added.

Data submitted to EMA, FDA and MHLW