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. 2012 May 30:344:e3645.
doi: 10.1136/bmj.e3645.

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

Laurent Azoulay  1 , Hui Yin, Kristian B Filion, Jonathan Assayag, Agnieszka Majdan, Michael N Pollak, Samy Suissa
Affiliations

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

Laurent Azoulay et al. BMJ. .

Abstract

Objective: To determine if the use of pioglitazone is associated with an increased risk of incident bladder cancer in people with type 2 diabetes.

Design: Retrospective cohort study using a nested case-control analysis.

Setting: Over 600 general practices in the United Kingdom contributing to the general practice research database.

Participants: The cohort consisted of people with type 2 diabetes who were newly treated with oral hypoglycaemic agents between 1 January 1988 and 31 December 2009. All incident cases of bladder cancer occurring during follow-up were identified and matched to up to 20 controls on year of birth, year of cohort entry, sex, and duration of follow-up. Exposure was defined as ever use of pioglitazone, along with measures of duration and cumulative dosage.

Main outcome measure: Risk of incident bladder cancer associated with use of pioglitazone.

Results: The cohort included 115,727 new users of oral hypoglycaemic agents, with 470 patients diagnosed as having bladder cancer during follow-up (rate 89.4 per 100,000 person years). The 376 cases of bladder cancer that were diagnosed beyond one year of follow-up were matched to 6699 controls. Overall, ever use of pioglitazone was associated with an increased rate of bladder cancer (rate ratio 1.83, 95% confidence interval 1.10 to 3.05). The rate increased as a function of duration of use, with the highest rate observed in patients exposed for more than 24 months (1.99, 1.14 to 3.45) and in those with a cumulative dosage greater than 28,000 mg (2.54, 1.05 to 6.14).

Conclusion: The use of pioglitazone is associated with an increased risk of incident bladder cancer among people with type 2 diabetes.

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Conflict of interest statement

Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: MNP served as a consultant for Novo Nordisk and Sanofi-Aventis and received research funding from Novo Nordisk; no other financial relationships with any organisations that might have an interest in the submitted work in the previous three years; and no other relationships or activities that could appear to have influenced the submitted work.

Figures

None
Fig 1 Flow of participants through study
See this image and copyright information in PMC

Comment in

References

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