| アブストラクト | AIMS: While genetic and biological studies indicated a potential association between proprotein-convertase subtilisin/kexin type 9 inhibitors (PCSK9i) and hyperglycaemia, real-world data are limited. Therefore, we sought to investigate this association using the FDA adverse event reporting system (FAERS). METHODS AND RESULTS: The FAERS database (2015-2020) was retrospectively queried to characterize reporting of hyperglycaemic adverse events (AEs) with PCSK9i. Disproportionality analyses were performed using the adjusted reporting odds ratio (adj.ROR), and the lower bound of the information component (IC) 95% credibility interval (IC025 > 0 is deemed significant). Among 7 295 624 eligible patients, 71 748 reports of evolocumab and 15 976 of alirocumab were identified. Compared to the full database, PCSK9i treatment was associated with increased reporting of hyperglycaemic AEs [n = 1841, adj.ROR = 1.14 (1.07-1.22), IC025 = 0.13]. Hyperglycaemic AEs were primarily mild hyperglycaemia [n = 1469, adj. ROR = 1.48 (1.36-1.62), IC025 = 0.51] rather than diabetes [n = 372, adj. ROR = 0.67 (0.60-0.74), IC025 = -0.90]. Among PCSK9i agents, evolocumab, but not alirocumab, was associated with hyperglycaemic AEs [n = 1587, adj. ROR = 1.24 (1.15-1.32), IC025 = 0.20; n = 254, adj. ROR = 0.73 (0.60-0.88), IC025 = -0.38, respectively]. Hyperglycaemic AEs were reported more often with PCSK9i compared to ezetimibe [adj.ROR = 1.99 (1.35-2.94)], and less often compared to statins [adj.ROR = 0.26 (0.25-0.28)]. Notably, hyperglycaemic AEs were reported more frequently by diabetic than by non-diabetic patients (P < 0.001), mostly occurred within 6 months of treatment and were reversible upon drug discontinuation. CONCLUSION: In a real-world setting, PCSK9i treatment was associated with increased reporting of mild hyperglycaemia, but not diabetes. While initial monitoring is warranted, the favourable glycaemic safety profile compared to statins supports their essential role in the management of lipid disorders. |
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| ジャーナル名 | European journal of preventive cardiology |
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| 投稿日 | 2021/12/14 |
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| 投稿者 | Goldman, Adam; Raschi, Emanuel; Cukierman-Yaffe, Tali; Dankner, Rachel; Shouval, Roni; Shechter, Michael; Ben-Zvi, Ilan; Gerstein, Hertzel C; Maor, Elad |
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| 組織名 | Sackler Faculty of Medicine, Tel-Aviv University, Ramat Aviv, Tel Aviv 69978,;Israel.;Leviev Heart Center, Sheba Medical Center, Derech Sheba 2, Ramat Gan, Israel.;Department of Internal Medicine, Sheba Medical Center, Derech Sheba 2, Ramat Gan,;Pharmacology Unit, Department of Medical and Surgical Sciences, Alma Mater;Studiorum, University of Bologna, Bologna, Italy.;Division of Endocrinology & Metabolism, Sheba Medical Center, Derech Sheba 2,;Ramat Gan, Israel.;Department of Epidemiology and Preventive Medicine, School of Public Health,;Sackler School of Medicine, Tel Aviv University, Ramat Aviv, Tel Aviv 69978,;Unit for Cardiovascular Epidemiology, The Gertner Institute for Epidemiology and;Health Policy Research, Sheba Medical Center, Derech Sheba 2, Ramat Gan, Israel.;Adult Bone Marrow Transplantation Service, Memorial Sloan Kettering Cancer;Center, New York, NY, USA.;Population Health Research Institute, McMaster University Medical Centre-Hamilton;Health Sciences, Hamilton, ON, Canada. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/34897409/ |
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