Cohort Study of Pioglitazone and Bladder Cancer in Patients With Diabetes
Following guidance from the United States Food and Drug Administration (FDA), the University
of Pennsylvania and Kaiser Permanente Northern California (KPNC) designed and is conducting
this study from their own database to assess the potential association between pioglitazone
and bladder cancer among patients with type 2 diabetes mellitus.
The study is being conducted over the course of 10 years, with a series of interim analyses
provided to the sponsor (Takeda) and the appropriate regulatory agencies.
In 2011, the planned 5-year interim analysis of this study was published in Diabetes Care.
That report included data from 1 January 1997 to 30 April 2008. Following reporting of these
data, there was a request from the FDA for an additional fourth interim analysis at 8 years
including data from 1 January 1997 to 31 December 2010.
In August 2011 the FDA requested a sensitivity analysis to assess change of cohort entry
criteria to minimize left censoring of exposure. Included in the FDA request was a duration
analysis for other antidiabetic medications.
Observational Model: Cohort, Time Perspective: Retrospective
Incident Diagnosis of Bladder Cancer Identified From the Kaiser Permanente Northern California Cancer Registry From 01 January 1997 to 31 December 2010.
Incident bladder cancers were identified from the KPNC cancer registry from January 1, 1997 to December 31, 2010. This was supplemented by case identification through surveillance of electronic pathology reports within KPNC for the period from January 1, 2005 to December 31, 2010. Incidence is reported as the number of newly diagnosed cases of bladder cancer per 100,000 person years. The 95% confidence interval was calculated using the Poisson method.
January 1, 1997 to December 31, 2010.
United States: Food and Drug Administration