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Association between incretin-related drugs and fractures in patients treated with pioglitazone: A pharmacovigilance study using the FDA Adverse Event Reporting System 

Katsuhiro Ohyama, Nonoka Abe, Takumi Okamoto, and Yusuke Hori

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Volume 64 (2026) p. 1 - 8

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 64 – No. 1/2026 (1-8)

Association between incretin-related drugs and fractures in patients treated with pioglitazone: A pharmacovigilance study using the FDA Adverse Event Reporting System 

Katsuhiro Ohyama, Nonoka Abe, Takumi Okamoto, and Yusuke Hori

Center for Experiential Pharmacy Practice, School of Pharmacy, Tokyo University of Pharmacy and Life Sciences, Tokyo, Japan
Objective: Diabetes mellitus (DM) causes various long-term complications and has, e.g., a direct negative effect on bone metabolism. Pioglitazone, which is used to treat DM, increases the risk of fractures. Reduced bone metabolism in patients with DM substantially impairs their quality of life. Therefore, this study aimed to determine the association of fractures with incretin-related drugs, dipeptidyl peptidase-4 inhibitors (DPP-4Is) and glucagon-like peptide-1 receptor agonists (GLP-1RAs), in patients treated with pioglitazone using a pharmacovigilance database.
Materials and methods: Data from the U.S. Food and Drug Administration Adverse Event Reporting System from the first quarter of 2013 to the end of 2019 were analyzed. The reporting odds ratio and information component values were used to evaluate the positive and inverse associations between the abovementioned drugs and fractures.
Results: Inverse associations were observed between incretin-related drugs and fractures in patients treated with DPP-4Is (sitagliptin) and GLP-1RAs (dulaglutide, exenatide, and liraglutide). A subgroup analysis revealed inverse associations between fractures and GLP-1RAs (exenatide and liraglutide) in patients treated with pioglitazone.
Conclusion: Our results suggest that incretin-related drugs, especially GLP-1RAs, reduce the risk of fractures in patients treated with diabetes medications such as pioglitazone.Correspondence to:
Katsuhiro Ohyama, PhD
Center for Experiential Pharmacy Practice
School of Pharmacy
Tokyo University of Pharmacy and Life Sciences
1432-1 Horinouchi, Hachioji
Tokyo 192-0392, Japan
Email: [email protected]

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