Cited by 239Pharmacovigilance and Adverse Drug ReactionsMetabolism, Diabetes, and CancerBladder and Urothelial Cancer Treatments

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Assessing the Association of Pioglitazone Use and Bladder Cancer Through Drug Adverse Event Reporting

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Piccinni, Carlo, Motola, Domenico, Marchesini, Giulio, Poluzzi, Elisabetta·2011·Diabetes Care

DOI 10.2337/dc10-2412PMC PMC3114317

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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.

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Authors: Piccinni, C., Motola, D., Marchesini, G., & Poluzzi, E.
Affiliations: University of Bologna (IT)
Corresponding author: Poluzzi, Elisabetta
ORCID: Piccinni, Carlo
Motola, Domenico
Marchesini, Giulio
Poluzzi, Elisabetta
Venue: Diabetes Care
Publisher: American Diabetes Association
Published: 2011-05-20
Volume: 34
Issue: 6
Pages: 1369-1371
ISSN: 0149-5992 (ISSN-L)
1935-5548
DOI: 10.2337/dc10-2412
PMC: PMC3114317
OpenAlex: W2133104620
Cited by: 239
References: 12
Citations by year: 2025: 4 · 2024: 3 · 2023: 1 · 2022: 5 · 2021: 5 · 2020: 2 · 2019: 12 · 2018: 18 · 2017: 16 · 2016: 14 · 2015: 20 · 2014: 23 · 2013: 37 · 2012: 60
FWCI: 56.32
Type: journal article
Language: en
Open access: hybrid
doi.org
Licence: cc-by-nc-nd
creativecommons.org/licenses/by-nc-nd/3.0/ (vor, 3753 d)
Locations: Diabetes Care (publishedVersion, cc-by-nc-nd)
Europe PMC (PubMed Central) (publishedVersion, cc-by-nc-nd)
PubMed Central (publishedVersion, cc-by-nc-nd)
PubMed (publishedVersion)
Archivio istituzionale della ricerca (Alma Mater Studiorum Università di Bologna) (submittedVersion)
Topics: Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Metabolism, Diabetes, and Cancer
Health Sciences › Medicine › Surgery › Bladder and Urothelial Cancer Treatments
Keywords: pioglitazone, bladder cancer, drug adverse events, antidiabetic drugs, FDA Adverse Event Reporting System, reporting odds ratio, insulin, metformin, glimepiride, exenatide, gliclazide, acarbose, drug safety
MeSH terms: Pioglitazone, Aged, Aged, 80 and over, Urinary Bladder Neoplasms, Female, Humans, Hypoglycemic Agents, Male, Middle Aged, United States, United States Food and Drug Administration, Adverse Drug Reaction Reporting Systems, Thiazolidinediones

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Assessing the Association of Pioglitazone Use and Bladder Cancer Through Drug Adverse Event Reporting

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