Analysis of Inclisiran in the US FDA Adverse Event Reporting System (FAERS): a focus on overall patient population and sex-specific subgroups

References

• Cheng Y, Rong J. Pro-resolving lipid mediators as therapeutic leads for cardiovascular diseases. Expert Opin Ther Targets. 2019;23(5):423–436. doi: 10.1080/14728222.2019.1599360
   PubMed Web of Science ®Google Scholar
• Cosentino F, Grant PJ, Aboyans V, et al. 2019 ESC guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD. Eur Heart J. 2020;41(2):255–323. doi: 10.1093/eurheartj/ehz486
   PubMed Web of Science ®Google Scholar
• Roth GA, Mensah GA, Johnson CO, et al. Global burden of cardiovascular diseases and risk factors, 1990-2019: update from the GBD 2019 study. J Am Coll Cardiol. 2020;76(25):2982–3021. doi: 10.1016/j.jacc.2020.11.010
   PubMed Web of Science ®Google Scholar
• Xu T, Ding W, Ji X, et al. Oxidative stress in cell death and cardiovascular diseases. Oxid Med Cell Longev. 2019;2019:1–11. doi: 10.1155/2019/9030563
   Web of Science ®Google Scholar
• Di Pino A, DeFronzo RA. Insulin resistance and atherosclerosis: implications for insulin sensitizing agents. Endocr Rev. 2019;40(6):1447–1467. doi: 10.1210/er.2018-00141
   PubMed Web of Science ®Google Scholar
• Tong Y, Wang Z, Cai L, et al. NLRP3 inflammasome and its central role in the cardiovascular diseases. Oxid Med Cell Longev. 2020;2020:1–8. doi: 10.1155/2020/4293206
   Web of Science ®Google Scholar
• Zhang Y, Chen H, Hong L, et al. Inclisiran: a new generation of lipid-lowering siRNA therapeutic. Front Pharmacol. 2023;14. doi: 10.3389/fphar.2023.1260921
   Web of Science ®Google Scholar
• Ference BA, Ginsberg HN, Graham I, et al. Low-density lipoproteins cause atherosclerotic cardiovascular disease. 1. Evidence from genetic, epidemiologic, and clinical studies. A consensusstatement from the European atherosclerosis society consensus panel. Eur Heart J. 2017;38(32):2459–2472. doi: 10.1093/eurheartj/ehx144
   PubMed Web of Science ®Google Scholar
• Boren J, Chapman MJ, Krauss RM, et al. Low-density lipoproteins cause atherosclerotic cardiovascular disease: pathophysiological, genetic, and therapeutic insights: a consensus statement from the European atherosclerosis society consensus panel. Eur Heart J. 2020;41(24):2313–2330. doi: 10.1093/eurheartj/ehz962
   PubMed Web of Science ®Google Scholar
• Seidah NG, Prat A, Pirillo A, et al. Novel strategies to target proprotein convertase subtilisin kexin 9: beyond monoclonal antibodies. Cardiovasc Res. 2019;115(3):510–518. doi: 10.1093/cvr/cvz003
   PubMed Web of Science ®Google Scholar
• Norata GD, Tibolla G, Catapano AL. Targeting PCSK9 for hypercholesterolemia. Annu Rev Pharmacol Toxicol. 2014;54(1):273–293. doi: 10.1146/annurev-pharmtox-011613-140025
   PubMedGoogle Scholar
• Scicchitano P, Milo M, Osanna Mallamaci, et al. Inclisiran in lipid management: a literature overview and future perspectives. Biomed Pharmacother. 2021;143:112227. doi: 10.1016/j.biopha.2021.112227
   PubMed Web of Science ®Google Scholar
• Merćep I, Friščić N, Strikić D, et al. Advantages and disadvantages of inclisiran: a small interfering ribonucleic acid molecule targeting PCSK9—A narrative review. Cardiovascu Ther. 2022;2022:1–6. doi: 10.1155/2022/8129513
   Web of Science ®Google Scholar
• Ray KK, Wright RS, Kallend D, et al. Two phase 3 trials of inclisiran in patients with elevated LDL cholesterol. N Engl J Med. 2020;382(16):1507–1519. doi: 10.1056/NEJMoa1912387
   PubMed Web of Science ®Google Scholar
• Brown EG. Using MedDRA: implications for risk management. Drug Saf. 2004;27(8):591–602. doi: 10.2165/00002018-200427080-00010
   PubMed Web of Science ®Google Scholar
• Rosenson RS, Baker SK, Jacobson TA, et al. An assessment by the statin muscle safety task force: 2014 update. J Of Clin Lipidol. 2014;8(3):S58–S71. doi: 10.1016/j.jacl.2014.03.004
   PubMed Web of Science ®Google Scholar
• Raal FJ, Kallend D, Ray KK, et al. Inclisiran for the treatment of heterozygous familial hypercholesterolemia. N Engl J Med. 2020;382(16):1520–1530. doi: 10.1056/NEJMoa1913805
   PubMed Web of Science ®Google Scholar
• Ray KK, Troquay RPT, Visseren FLJ, et al. Long-term efficacy and safety of inclisiran in patients with high cardiovascular risk and elevated LDL cholesterol (ORION-3): results from the 4-year open-label extension of the ORION-1 trial. Lancet Diabetes Endocrinol. 2023;11(2):109–119. doi: 10.1016/S2213-8587(22)00353-9
   PubMed Web of Science ®Google Scholar
• Ray KK, Kallend D, Leiter LA, et al. Effect of inclisiran on lipids in primary prevention: the ORION-11 trial. Eur Heart J. 2022;43(48):5047–5057. doi: 10.1093/eurheartj/ehac615
   PubMed Web of Science ®Google Scholar
• Dyrbuś K, Gąsior M, Penson P, et al. Inclisiran-new hope in the management of lipid disorders? J Clin Lipidol. 2020;14(1):16–27. doi: 10.1016/j.jacl.2019.11.001
   PubMed Web of Science ®Google Scholar
• German CA, Shapiro MD. Small interfering RNA therapeutic inclisiran: a new approach to targeting PCSK9. BioDrugs. 2020;34(1):1–9. doi: 10.1007/s40259-019-00399-6
   PubMed Web of Science ®Google Scholar
• Zijlstra LE, Trompet S, Mooijaart SP, et al. Renal impairment, cardiovascular disease, and the short-term efficacy and safety of PCSK9 targeted by Inclisiran. Mayo Clin Proc. 2020;95(1):12–14. doi: 10.1016/j.mayocp.2019.11.010
   PubMed Web of Science ®Google Scholar
• Wright RS, Collins MG, Stoekenbroek RM, et al. Effects of renal impairment on the pharmacokinetics, efficacy, and safety of Inclisiran: an analysis of the ORION-7 and ORION-1 studies. Mayo Clin Proc. 2020;95(1):77–89. doi: 10.1016/j.mayocp.2019.08.021
   PubMed Web of Science ®Google Scholar
• Ray KK, Raal FJ, Kallend DG, et al. Inclisiran and cardiovascular events: a patient-level analysis of phase III trials. Eur Heart J. 2023;44(2):129–138. doi: 10.1093/eurheartj/ehac594
   PubMed Web of Science ®Google Scholar
• Corrao G, Ibrahim B, Nicotra F, et al. Statins and the risk of diabetes: evidence from a large population-based cohort study. Diabetes Care. 2014;37(8):2225–2232. doi: 10.2337/dc13-2215
   PubMed Web of Science ®Google Scholar