| アブストラクト | Background: Cardiovascular safety concerns for major cardiovascular events (MACE) were raised during the clinical trials of romosozumab. We aimed to evaluate the cardiovascular safety profile of romosozumab in a large pharmacovigilance database. Methods: All cases reported between January 2019 and December 2020 where romosozumab was reported were extracted from the Food and Drug Administration Adverse Event Reporting System (FAERS). The outcome of interest was MACE (myocardial infarction (MI), stroke, or cardiovascular death). A disproportionality analysis was conducted by estimating the reporting odds ratios (RORs) and 95% confidence intervals. Disproportionality analyses were stratified by sex and reporting region (US, Japan, other). Results: Of the 1995 eligible cases with romosozumab, the majority (N = 1188; 59.5%) originated from Japan. Overall, 206 suspected MACE reports were identified, of which the majority (n = 164; 13.8%) were from Japan, and 41 (5.2%) were from the United States (US). Among Japanese reports, patients were older and more frequently male than reports from the US. Similarly, cases with a reported MACE were older and had higher reports of cardioprotective drugs than those without cardiovascular events. Elevated reports for MACE (ROR 4.07, 95% CI: 2.39-6.93) was identified overall, which was primarily driven by the significant disproportionality measures in the Japanese reports. Conclusions: The current pharmacovigilance study identified a potential signal for elevated MACE, particularly in Japan. The results support the current safety warnings from the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to avoid use in high-risk patients. |
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| 投稿日 | 2021/5/1 |
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| 投稿者 | Vestergaard Kvist, Annika; Faruque, Junaid; Vallejo-Yague, Enriqueta; Weiler, Stefan; Winter, Elizabeth M; Burden, Andrea M |
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| ジャーナル名 | Journal of clinical medicine |
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| 組織名 | Department of Chemistry and Applied Biosciences, Institute of Pharmaceutical;Sciences, ETH Zurich, 8092 Zurich, Switzerland.;Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, ON M5S 3M2,;Canada.;National Poisons Information Centre, Tox Info Suisse, Associated Institute of the;University of Zurich, 8032 Zurich, Switzerland.;Center for Bone Quality, Department of Internal Medicine, Division of;Endocrinology, Leiden University Medical Center, 2333 ZA Leiden, The Netherlands. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/33924496/ |
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