Dipeptidyl peptidase-4 inhibitors and risk of venous thromboembolism: data mining of FDA adverse event reporting system
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SHORT RESEARCH REPORT
Dipeptidyl peptidase‑4 inhibitors and risk of venous thromboembolism: data mining of FDA adverse event reporting system Wenchao Lu1,2 · Shusen Sun3 · Jingkai Wei4 · Sydney Thai4 · Dandan Li5 · Huilin Tang6 · Tiansheng Wang4 · Lulu Sun1 Received: 11 October 2019 / Accepted: 11 April 2020 © Springer Nature Switzerland AG 2020
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. Keywords DPP-4 inhibitors · FAERS database · Venous thromboembolism
Electronic supplementary material The online version of this article (https://doi.org/10.1007/s11096-020-01037-w) contains supplementary material, which is available to authorized users. * Lulu Sun [email protected] 1
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Department of Epidemiology, University of North Carolina Gillings School of Global Public Health, Chapel Hill, NC, USA
Department of Pharmacy, Beijing Shijitan Hospital, Capital Medical University, Beijing, China
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Department of Pharmacy, Beijing Chaoyang Hospital, Capital Medical University, Beijing, China
Department of Pharmacy, Beijing Friendship Hospital, Capital Medical University, Beijing, China
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College of Pharmacy and Health Sciences, Western New England University, Springfield, MA, USA
Institute for Drug Evaluation, Peking University Health Science Center, Beijing, China
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Impacts on practice • Our study suggested that DPP-4 inhibitors didn’t have
increased venous thromboembolism risk; however, DPP-4 inhibitors
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