Affiliation:
1. Department of Pharmacology, University of Bologna, Bologna, Italy
2. Metabolic Diseases & Clinical Dietetics, Department of Clinical Medicine, University of Bologna, Bologna, Italy
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.
Publisher
American Diabetes Association
Subject
Advanced and Specialized Nursing,Endocrinology, Diabetes and Metabolism,Internal Medicine
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