Benefit/Risk Profile Remains Positive for Pioglitazone as an Important Treatment Option for Type 2 Diabetes

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The FINANCIAL — Takeda Pharmaceutical Company Limited on December 16 commented on letters to the editor published in the December 15th Journal of the American Medical Association (JAMA), referencing Pioglitazone Use and Risk of Bladder Cancer and Other Common Cancers in Persons With Diabetes, the 10-year epidemiology study of pioglitazone use conducted by the University of Pennsylvania (U. of Penn.) and Division of Research at Kaiser Permanente Northern California (KPNC), which was published by JAMA on July 21.

Takeda disagrees with the opinions stated in the Letters to the Editor from Benjamin J. Davies, MD, Sonal Singh, MD, MPH, and Marc. A. Suchard, MD, PhD, who purport to analyze the U. of Penn and KPNC study.1,2 It is important to note that the study had considerable input from the United States Food and Drug Administration (FDA). It also is important to note that Dr. Davies, Dr. Singh and Dr. Suchard were commissioned to conduct their analysis by plaintiffs’ attorneys who are engaged in lawsuits against Takeda regarding use of pioglitazone, according to Takeda.

“We are confident in the positive benefit/risk profile of pioglitazone and agree with the robust methodology that was created by the world-class epidemiologists at the U. of Pennsylvania and KPNC. This study was performed following thorough consultation with the FDA,” said Andy Plump, M.D., Ph.D., Takeda Pharmaceuticals Chief Medical & Scientific Officer. “The study authors have worked diligently over many years to deliver these findings on pioglitazone. This study is one of the most comprehensive real world data analyses ever undertaken. This is strong hypothesis driven science and I commend the investigators for their efforts.”

A Cohort Study of Pioglitazone and Bladder Cancer in Patients with Diabetes was a prospective cohort study designed to examine whether pioglitazone treatment for diabetes is associated with increased incidence of bladder cancer.3 This 10 years observational prospective study included 193,099 patients diagnosed with Type 2 diabetes between 1997 and 2012. This extensive research demonstrated no statistically significant increased risk of bladder cancer among patients ever exposed to pioglitazone compared to those never exposed. 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. This is the third cohort study with long-term data to demonstrate no association of pioglitazone use and risk of bladder cancer.

“Long-term observational studies underscore the significant potential of real world data to help further understand the effects of our medicines on patients,” said Plump. “Takeda continues to ensure that all critical data is shared with regulatory bodies and with healthcare professionals so they have the best available information to make treatment decisions.”

 

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