Thromboembolism profiles associated with cyclin-dependent kinase 4/6 inhibitors : a real-world pharmacovigilance study and a systematic review
BACKGROUND: Thrombosis is the second leading cause of mortality in cancer patients. This study aimed to investigate the association between cyclin-dependent kinase 4 and 6 inhibitors (CDK4/6i) and thrombosis.
RESEARCH DESIGN AND METHODS: A retrospective pharmacovigilance analysis based on real-world data combined with a systematic review was used to explore the thrombotic risk profiles of CDK4/6i. The study has been registered with Prospero (CRD42021284218).
RESULT: In the pharmacovigilance analysis, CDK4/6i showed a higher rate of reported venous thromboembolism (VTE) (ROR = 2.78, 95% CI = 2.64-2.92), with the highest signal for trilaciclib (ROR = 27.55, 95% CI = 13.43-56.52) but only 9 cases, followed by abemaciclib (ROR = 3.73, 95% CI = 3.19-4.37). For arterial thromboembolism (ATE), only ribociclib increased the reporting rate (ROR = 2.14, 95% CI = 1.91-2.41). In the meta-analysis, palbociclib, abemaciclib, and trilaciclib all increased the risk of VTE (OR = 2.23, 3.17, and 3.90). In the subgroup analysis, only abemaciclib increased the risk of ATE (OR = 2.11, 95% CI = 1.12-3.99) .
CONCLUSIONS: CDK4/6i had different profiles of thromboembolism. Palbociclib, abemaciclib, or trilaciclib increased the risk of VTE. Ribociclib and abemaciclib showed a weak association with the risk of ATE.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:22 |
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| Enthalten in: |
Expert opinion on drug safety - 22(2023), 7 vom: 31. Juli, Seite 599-609 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Gao, Siyuan [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 02.11.2023 Date Revised 02.11.2023 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1080/14740338.2023.2181338 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM353008613 |
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| 245 | 1 | 0 | |a Thromboembolism profiles associated with cyclin-dependent kinase 4/6 inhibitors |b a real-world pharmacovigilance study and a systematic review |
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| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a BACKGROUND: Thrombosis is the second leading cause of mortality in cancer patients. This study aimed to investigate the association between cyclin-dependent kinase 4 and 6 inhibitors (CDK4/6i) and thrombosis | ||
| 520 | |a RESEARCH DESIGN AND METHODS: A retrospective pharmacovigilance analysis based on real-world data combined with a systematic review was used to explore the thrombotic risk profiles of CDK4/6i. The study has been registered with Prospero (CRD42021284218) | ||
| 520 | |a RESULT: In the pharmacovigilance analysis, CDK4/6i showed a higher rate of reported venous thromboembolism (VTE) (ROR = 2.78, 95% CI = 2.64-2.92), with the highest signal for trilaciclib (ROR = 27.55, 95% CI = 13.43-56.52) but only 9 cases, followed by abemaciclib (ROR = 3.73, 95% CI = 3.19-4.37). For arterial thromboembolism (ATE), only ribociclib increased the reporting rate (ROR = 2.14, 95% CI = 1.91-2.41). In the meta-analysis, palbociclib, abemaciclib, and trilaciclib all increased the risk of VTE (OR = 2.23, 3.17, and 3.90). In the subgroup analysis, only abemaciclib increased the risk of ATE (OR = 2.11, 95% CI = 1.12-3.99) | ||
| 520 | |a CONCLUSIONS: CDK4/6i had different profiles of thromboembolism. Palbociclib, abemaciclib, or trilaciclib increased the risk of VTE. Ribociclib and abemaciclib showed a weak association with the risk of ATE | ||
| 650 | 4 | |a Systematic Review | |
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| 700 | 1 | |a He, Zhichao |e verfasserin |4 aut | |
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| 700 | 1 | |a Liang, Dan |e verfasserin |4 aut | |
| 700 | 1 | |a Yang, Shan |e verfasserin |4 aut | |
| 700 | 1 | |a Mo, Jiayao |e verfasserin |4 aut | |
| 700 | 1 | |a Lam, Kakei |e verfasserin |4 aut | |
| 700 | 1 | |a Yu, Xiaoxia |e verfasserin |4 aut | |
| 700 | 1 | |a Huang, Ming |e verfasserin |4 aut | |
| 700 | 1 | |a Wu, Junyan |e verfasserin |4 aut | |
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