The use of pioglitazone and the risk of bladder cancer in people with type 2 diabetes: nested case-control study.

3 4 5 In the Prospective Pioglitazone Clinical Trial in Macrovascular Events (PROactive) trial, the reported incidence of bladder cancer was higher among participants randomised to pioglitazone than among those randomised to placebo (14 v 6 cases), although this failed to reach statistical significance (P=0.069). 1 However, it was later reported that one case in the placebo group showed benign histology, 6 and the exclusion of this case resulted in a statistically significant increased risk of bladder cancer (14 v 5 cases, relative risk 2.83, 95% confidence interval 1.02 to 7.85). 7 With respect

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The adjusted rate ratio was numerically increased but did not reach statistical significance (adjusted rate ratio 1.60, 95% confidence interval 0.88 to 2.90) owing to few users (19 v 36).

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