| アブストラクト | BACKGROUND: CDK4/6 inhibitors are highly valued, but the incidence of cardiovascular adverse events (CVAEs) associated with CDK4/6 inhibitors is not clear. OBJECTIVE: Our aim was therefore to assess the risk of developing CVAEs associated with CDK4/6 inhibitors, by conducting a systematic review and meta-analysis of randomized controlled trials (RCTs), along with a pharmacovigilance study of the FDA Adverse Event Reporting System (FAERS) database. METHODS: Eligible CVAEs were extracted from the ClinicalTrials.gov registry. A systematic search of electronic databases (PubMed, Embase, Cochrane Library, and important meetings) until 3 September 2023 was conducted. A disproportionality analysis was performed from the first quarter (Q1) of 2013 to Q1 of 2023 using data from the FAERS database. Study heterogeneity was assessed using the I(2) statistic. Using Peto odds ratio (Peto OR) and inverse variance methods to calculate the risk and incidence of CVAEs associated with CDK4/6 inhibitors. RESULTS: In total, 17 RCTs with 23,437 patients were included in our meta-analysis. During the follow-up period of 8.4-34.0 months, CDK4/6 inhibitors significantly increased the risk of CVAEs (Peto OR, 1.86, 95% confidence interval, 1.30-2.68, P < 0.01). The rates of hypertension and QT prolongation were 68.07 (62.87-73.27) and 57.15 (50.83-63.48) per 1000 patients, respectively. Moreover, we identified nine CVAEs that were not reported in RCTs. These included acute coronary syndrome, arrhythmia, lymphoedema, hot flush, vein rupture, thrombophlebitis migrans, embolism venous, angiopathy and intracardiac thrombus, which were found to be strongly correlated with CDK4/6 inhibitors. Furthermore, the risk of CVAEs varied depending on the specific CDK4/6 inhibitors used, its combination with different endocrine therapies, and the patient's treatment stage. CONCLUSION: CDK4/6 inhibitors increase the risk of CVAEs, some of which may lead to serious consequences. Early recognition and management of CVAEs is of great importance in clinical practice. REGISTRATION: PROSPERO registration number CRD42023462059. |
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| ジャーナル名 | American journal of cardiovascular drugs : drugs, devices, and other interventions |
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| Pubmed追加日 | 2024/12/19 |
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| 投稿者 | Zhang, Chengrong; Shen, Guoshuang; Li, Shengmei; Ma, Fei; Li, Huihui; Tang, Yuyao; Li, YongXin; Li, Zhoujuan; Zhu, Zijun; Qiu, Tianlei; Liu, Zhilin; Zhao, Yi; Huang, Shifeng; Zhao, Fuxing; Kong, Fanzhen; Zhao, Jiuda |
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| 組織名 | Breast Disease Diagnosis and Treatment Center of Affiliated Hospital of Qinghai;University and Affiliated Cancer Hospital of Qinghai University, Xining, 810000,;China.;State Key Laboratory of Molecular Oncology, National Cancer Center/National;Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical;Sciences and Peking Union Medical College, Beijing, China.;Department of Breast Medical Oncology, Shandong Cancer Hospital and Institute,;Shandong First Medical University and Shandong Academy of Medical Sciences,;Jinan, China.;China. jiudazhao@126.com. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/39695060/ |
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