Int J Clin Pharmacol Ther. 2021 Oct 08; doi: 10.5414/CP204066. Epub 2021 Oct 08.
Association of gynecomastia with antidiabetic medications in older adults: data mining from different national pharmacovigilance databases.
International journal of clinical pharmacology and therapeutics
Katsuhiro Ohyama, Hiroyuki Tanaka, Junichiro Shindo, Manami Shibayama, Maya Iwata, Yusuke Hori
PMID: 34622771
DOI: 10.5414/CP204066
Abstract
OBJECTIVE: Gynecomastia is a benign proliferation of the glandular breast tissue in men and is generally caused by a decrease in androgen and an increase in estrogen. Diabetes has been reported to be a risk factor for lowering androgen levels. Moreover, lowered androgen levels are more common in older men. In the present study, we aimed to evaluate the signals for gynecomastia in older men on antidiabetic medications.
MATERIALS AND METHODS: A disproportionality analysis was performed to detect the signals for antidiabetic drug-associated gynecomastia in the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) and the Japanese Adverse Drug Event Report database (JADER), using the reporting odds ratio (ROR) and information component (IC).
RESULTS: Among 8 classes of medications for diabetes, a signal was detected only for dipeptidyl peptidase-4 (DPP-4) inhibitors (ROR: 1.90, 95% confidence interval (CI): 1.27 - 2.83; IC: 0.84, 95% CI: 0.26 - 1.42) in the FAERS. Regarding individual drugs, ROR and IC signals were detected for sitagliptin (ROR: 2.37, 95% CI: 1.48 - 3.79; IC: 1.12, 95% CI: 0.44 - 1.79) and vildagliptin (ROR: 3.34, 95% CI: 1.39 - 8.08; IC: 1.26, 95% CI: 0.07 - 2.44) in the FAERS and only for sitagliptin (ROR: 4.84, 95% CI: 1.92 - 12.2; IC: 1.48, 95% CI: 0.24 - 2.73) in the JADER.
CONCLUSION: This study showed an association between DPP-4 inhibitor use and gynecomastia in older men with diabetes. Further pharmacoepidemiological studies are warranted to verify this finding.
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