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Dipeptidyl peptidase-4 inhibitors and risk of venous thromboembolism: data mining of FDA adverse event reporting system

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Abstract

Background

A recent study is raising concerns that dipeptidyl peptidase 4 inhibitors are associated with increased risk of venous thromboembolism.

Objective

We aimed to assess the association between dipeptidyl peptidase-4 inhibitors and venous thromboembolism using the US Food and Drug Administration Adverse Event Reporting System database.

Methods

We searched the venous thromboembolism cases related to dipeptidyl peptidase-4 inhibitors from 2004 first quarter to 2018 first quarter. We compared dipeptidyl peptidase-4 inhibitors versus three groups: (1) all other glucose-lowering drugs excluding insulins; (2) sulfonylureas and sodium–glucose-cotransporter-2 inhibitors; (3) sodium–glucose-cotransporter-2 inhibitors. In each comparison, we calculated proportional rate ratios and 95% confidence ratios by SAS 9.4.

Results

We obtained 873 dipeptidyl peptidase-4 inhibitors-associated venous thromboembolism events. Compared to all other glucose lowering-drugs excluding insulins, the proportional reporting ratio for overall venous thromboembolism, deep vein thrombosis, pulmonary embolism were 0.92 (0.86, 0.99), 0.91 (0.82,1.01), and 0.82 (0.74,0.90), respectively; the proportional reporting ratio for portal vein thrombosis, splenic vein thrombosis, mesenteric vein thrombosis were 3.94 (2.96, 5.25), 10.80 (6.14, 18.99), and 4.98 (2.76,8.96), respectively.

Conclusion

Our analysis found no association between dipeptidyl peptidase-4 inhibitors and venous thromboembolism risk, while moderate to strong signals of portal vein thrombosis, splenic vein thrombosis, mesenteric vein thrombosis risks were observed.

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Acknowledgements

None.

Funding

WL receives the Student-Innovation Fund (69003Y0052) from the School of Pharmaceutical Sciences, Peking University.

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Authors and Affiliations

  1. Department of Pharmacy, Beijing Shijitan Hospital, Capital Medical University, Beijing, China

    Wenchao Lu & Lulu Sun

  2. Department of Pharmacy, Beijing Chaoyang Hospital, Capital Medical University, Beijing, China

    Wenchao Lu

  3. College of Pharmacy and Health Sciences, Western New England University, Springfield, MA, USA

    Shusen Sun

  4. Department of Epidemiology, University of North Carolina Gillings School of Global Public Health, Chapel Hill, NC, USA

    Jingkai Wei, Sydney Thai & Tiansheng Wang

  5. Department of Pharmacy, Beijing Friendship Hospital, Capital Medical University, Beijing, China

    Dandan Li

  6. Institute for Drug Evaluation, Peking University Health Science Center, Beijing, China

    Huilin Tang

Authors
  1. Wenchao Lu
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  2. Shusen Sun
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  3. Jingkai Wei
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  4. Sydney Thai
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  6. Huilin Tang
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  7. Tiansheng Wang
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  8. Lulu Sun
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Correspondence to Lulu Sun.

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Lu, W., Sun, S., Wei, J. et al. Dipeptidyl peptidase-4 inhibitors and risk of venous thromboembolism: data mining of FDA adverse event reporting system. Int J Clin Pharm 42, 1364–1368 (2020). https://doi.org/10.1007/s11096-020-01037-w

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  • DOI: https://doi.org/10.1007/s11096-020-01037-w

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