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Pioglitazone is contraindicated in patients with bladder cancer or a history
of bladder cancer, or in patients with uninvestigated macroscopic haematuria.
Risk factors for bladder cancer (age, smoking history, exposure to some occupational
or chemotherapy agents or prior radiation treatment in the pelvic region) should
be assessed before initiating pioglitazone, and any macroscopic or microscopic
haematuria investigated (1).
A systematic review and meta-analysis concerning the risk of bladder cancer
with thiazolidinediones has been undertaken (2).
- the analysis screened 230 citations and included 18 studies, comprising
five randomized controlled trials (RCTs) and 13 observational studies
- meta-analysis showed a significantly higher overall risk of bladder
cancer with pioglitazone in RCTs [7878 participants; odds ratio (OR) 2.51,
95% confidence interval (CI) 1.09-5.80] and observational studies (>2.6
million patients; OR for 'ever' users vs. non-users 1.21, 95% CI 1.09-1.35)
- subgroup analysis of observational studies by cumulative dose showed
the risk of bladder cancer to be greatest with >28.0g of pioglitazone
(OR 1.64, 95% CI 1.28-2.12)
- a significantly increased risk was found with both 12-24 months
(OR 1.41, 95% CI 1.16-1.71) and >24 months (OR 1.51, 95% CI 1.26-1.81)
cumulative durations of pioglitazone exposure
- no significant risk was seen with rosiglitazone in RCTs (OR 0.84,
95% CI 0.35-2.04) or 'ever' users vs. non-users in observational studies
(OR 1.03, 95% CI 0.94-1.12); the evidence for any relationship between
bladder cancer risk and rosiglitazone cumulative duration is limited
- the study authors concluded that there was "..A modest but clinically
significant increase in the risk of bladder cancer with pioglitazone was found,
which appears to be related to cumulative dose and duration of exposure. We
recommend that prescribers limit pioglitazone use to shorter durations..."
- MeReC Bulletin (2012);22;5
RM et al. Thiazolidinediones and associated risk of bladder cancer: a systematic
review and meta-analysis. Br J Clin Pharmacol. 2014 Aug;78(2):258-73.
Last reviewed 01/2018