Dataset Information

Assessing the association of pioglitazone use and bladder cancer through drug adverse event reporting.

ABSTRACT:

Objective

To analyze the association between pioglitazone use and bladder cancer through a spontaneous adverse event reporting system for medications.

Research design and methods

Case/noncase bladder cancer reports associated with antidiabetic drug use were retrieved from the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (AERS) between 2004 and 2009 and analyzed by the reporting odds ratio (ROR).

Results

Ninety-three reports of bladder cancer were retrieved, corresponding to 138 drug-reaction pairs (pioglitazone, 31; insulin, 29; metformin, 25; glimepiride, 13; exenatide, 8; others, 22). ROR was indicative of a definite risk for pioglitazone (4.30 [95% CI 2.82-6.52]), and a much weaker risk for gliclazide and acarbose, with very few cases being treated with these two drugs (6 and 4, respectively).

Conclusions

In agreement with preclinical and clinical studies, AERS analysis is consistent with an association between pioglitazone and bladder cancer. This issue needs constant epidemiologic surveillance and urgent definition by more specific studies.

SUBMITTER: Piccinni C

PROVIDER: S-EPMC3114317 | biostudies-literature | 2011 Jun

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Assessing the association of pioglitazone use and bladder cancer through drug adverse event reporting.

Piccinni Carlo C Motola Domenico D Marchesini Giulio G Poluzzi Elisabetta E

Diabetes care 20110422 6

<h4>Objective</h4>To analyze the association between pioglitazone use and bladder cancer through a spontaneous adverse event reporting system for medications.<h4>Research design and methods</h4>Case/noncase bladder cancer reports associated with antidiabetic drug use were retrieved from the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (AERS) between 2004 and 2009 and analyzed by the reporting odds ratio (ROR).<h4>Results</h4>Ninety-three reports of bladder cancer were r ...[more]

PMID: 21515844

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Dataset Information

Assessing the association of pioglitazone use and bladder cancer through drug adverse event reporting.

Objective

Research design and methods

Results

Conclusions

Publications

Assessing the association of pioglitazone use and bladder cancer through drug adverse event reporting.

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