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Original

Inverse association between DPP-4 inhibitor use and fracture in older adults: A disproportionality analysis of the FAERS and JADER 

Katsuhiro Ohyama, Takumi Okamoto, and Yusuke Hori

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Volume 61 (2023) p. 16 - 23

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 61 – No. 1/2023 (16-23)

Inverse association between DPP-4 inhibitor use and fracture in older adults: A disproportionality analysis of the FAERS and JADER 

Katsuhiro Ohyama, Takumi Okamoto, and Yusuke Hori

Center for Experiential Pharmacy Practice, School of Pharmacy, Tokyo University of Pharmacy and Life Sciences, Tokyo, Japan
Objective: Fractures are significantly associated with increased morbidity and mortality in older individuals; additionally, patients with diabetes mellitus are highly prone to fractures. The aim of the present study was to examine the association between dipeptidyl peptidase-4 (DPP-4) inhibitor use and the risk of fracture in older patients by analyzing data obtained from spontaneous adverse event reporting databases from the United States and Japan.
Materials and methods: Data on older patients registered in the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) from the first quarter of 2013 to the end of 2019 and data registered in the Japanese Adverse Drug Event Report database (JADER) from April 2004 to December 2019 were used. Reporting odds ratio (ROR) and information component (IC) values were used for disproportionality analysis.
Results: Significant inverse associations between DPP-4 inhibitor use and fracture were found for DPP-4 inhibitors as a whole (ROR = 0.80; 95% CI = 0.73 – 0.88; IC = –0.31, 95% CI = –0.46 to –0.17); linagliptin (ROR = 0.74; 95% CI = 0.59 – 0.94; IC = –0.42, 95% CI = –0.75 to –0.08); and sitagliptin (ROR = 0.77; 95% CI = 0.68 – 0.88; IC = –0.36, 95% CI = –0.55 to –0.17) in the analyses of FAERS data. Similarly, significant inverse associations were also found for DPP-4 inhibitors as whole (ROR = 0.71; 95% CI = 0.59 to 0.86; IC = –0.46, 95% CI = –0.74 to –0.18); sitagliptin (ROR = 0.70; 95% CI = 0.52 – 0.95; IC = –0.49, 95% CI = –0.93 to -0.05); and vildagliptin (ROR = 0.54; 95% CI = 0.35 – 0.83; IC = –0.85, 95% CI = –1.49 to –0.22) in the analyses of JADER data.
Conclusion: Our analysis of adverse event databases using different algorithms revealed that DPP-4 inhibitor use was inversely associated with fracture in older patients.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]

Original

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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42.00 $

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42.00 $

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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