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Review

Thromboembolic Risk of C1 Esterase Inhibitors: A Systematic Review on Current Evidence

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References

  • Dewald G, Bork K. Missense mutations in the coagulation factor XII (Hageman factor) gene in hereditary angioedema with normal C1 inhibitor. Biochem Biophys Res Commun. 2006;343(4):1286–1289.
  • Maurer M, Magerl M, Ansotegui I, et al. The international WAO/EAACI guideline for the management of hereditary angioedema – the 2017 revision and update. World Allergy Organ J. 2018;11(1):5.
  • Rosen FS, Pensky J, Donaldson V, et al. Hereditary angioneurotic edema: two genetic variants. Science. 1965;148(3672):957–958.
  • de Agostini A, Lijnen HR, Pixley RA, et al. Inactivation of factor XII active fragment in normal plasma. Predominant role of C-1-inhibitor. J Clin Invest. 1984;73(6):1542–1549.
  • Gigli I, Mason JW, Colman RW, et al. Interaction of plasma kallikrein with the C1 inhibitor. J Immunol. 1970;104(3):574–581.
  • Whalley ET, Amure YO, Lye RH. Analysis of the mechanism of action of bradykinin on human basilar artery in vitro. Naunyn Schmiedebergs Arch Pharmacol. 1987;335(4):433–437.
  • Fields T, Ghebrehiwet B, Kaplan AP. Kinin formation in hereditary angioedema plasma: evidence against kinin derivation from C2 and in support of “spontaneous” formation of bradykinin. J Allergy Clin Immunol. 1983;72(1):54–60.
  • Farkas H, Martinez-Saguer I, Bork K, et al. International consensus on the diagnosis and management of pediatric patients with hereditary angioedema with C1 inhibitor deficiency. Allergy. 2017;72(2):300–313.
  • Fox J, Vegh AB, Martinez-Saguer I, et al. Safety of a C1-inhibitor concentrate in pregnant women with hereditary angioedema. Allergy Asthma Proc. 2017;38(3):216–221.
  • Chrvala CA, Caspi A. C1 esterase inhibitor (human). P T. 2010;35(7 Section 2):2–3.
  • Package insert - CINRYZE [Internet]. [ cited 2020 Jan 21]. Available from: https://webcache.googleusercontent.com/search?q=cache:r4RZENPwlt0J:https://www.fda.gov/media/75907/download+&cd=1&hl=en&ct=clnk&gl=us
  • Package insert - HAEGARDA [Internet]. [ cited 2020 Jan 21]. Available from: https://webcache.googleusercontent.com/search?q=cache:tBFVT_NUCTMJ:https://www.fda.gov/media/105611/download+&cd=2&hl=en&ct=clnk&gl=us
  • Labeling US- Salix_Pharming revised 062414 [Internet]. [ cited 2020 Jan 21]. Available from: https://webcache.googleusercontent.com/search?q=cache:XOPWSHmHB3MJ:https://www.fda.gov/media/89212/download+&cd=1&hl=en&ct=clnk&gl=us
  • Crowther M, Bauer KA, Kaplan AP. The thrombogenicity of C1 esterase inhibitor (human): review of the evidence. Allergy Asthma Proc. 2014;35(6):444–453.
  • Bernstein JA. Update on angioedema: evaluation, diagnosis, and treatment. Allergy Asthma Proc. 2011;32(6):408–412.
  • Bygum A. Hereditary angio-oedema in Denmark: a nationwide survey. Br J Dermatol. 2009;161(5):1153–1158.
  • van Geffen M, Cugno M, Lap P, et al. Alterations of coagulation and fibrinolysis in patients with angioedema due to C1-inhibitor deficiency. Clin Exp Immunol. 2012;167(3):472–478.
  • Reshef A, Zanichelli A, Longhurst H, et al. Elevated D-dimers in attacks of hereditary angioedema are not associated with increased thrombotic risk. Allergy. 2015;70(5):506–513.
  • Nielsen EW, Morrissey J, Olsen JO, et al. Factor VIIa in patients with C1-inhibitor deficiency. Thromb Haemost. 1995;74(4):1103–1106.
  • Levi M, Roem D, AM K, et al. Assessment of the relative contribution of different protease inhibitors to the inhibition of plasmin in vivo. Thromb Haemost. 1993;69(2):141–146.
  • Zeerleder S. C1-inhibitor: more than a serine protease inhibitor. Semin Thromb Hemost. 2011;37(4):362–374.
  • Huisman LG, van Griensven JM, Kluft C. On the role of C1-inhibitor as inhibitor of tissue-type plasminogen activator in human plasma. Thromb Haemost. 1995;73(3):466–471.
  • Schousboe I. Binding of activated Factor XII to endothelial cells affects its inactivation by the C1-esterase inhibitor. Eur J Biochem. 2003;270(1):111–118.
  • Wuillemin WA, Minnema M, Meijers JC, et al. Inactivation of factor XIa in human plasma assessed by measuring factor XIa-protease inhibitor complexes: major role for C1-inhibitor. Blood. 1995;85(6):1517–1526.
  • Schousboe I. Factor XIIa activation of plasminogen is enhanced by contact activating surfaces and Zn2+. Blood Coagul Fibrinolysis. 1997;8(2):97–104.
  • Zeerleder S, Schloesser M, Redondo M, et al. Reevaluation of the incidence of thromboembolic complications in congenital factor XII deficiency–a study on 73 subjects from 14 Swiss families. Thromb Haemost. 1999;82(4):1240–1246.
  • Zuraw BL, Kalfus I. Safety and efficacy of prophylactic nanofiltered C1-inhibitor in hereditary angioedema. Am J Med. 2012;125(9):938.e1–7.
  • Arzneimittelkommission der deutschen Ärzteschaft: schwerwiegende Thrombenbildung nach Berinert® HS [Internet]. [2020 Mar 4]. Available from: https://www.aerzteblatt.de/archiv/22549/Arznei%C2%ADmittel%C2%ADkommission-der-deutschen-Aerzteschaft-Schwerwiegende-Thrombenbildung-nach-Berinert-HS
  • Tassani P, Kunkel R, Richter JA, et al. Effect of C1-esterase-inhibitor on capillary leak and inflammatory response syndrome during arterial switch operations in neonates. J Cardiothorac Vasc Anesth. 2001;15(4):469–473.
  • Gandhi PK, Gentry WM, Bottorff MB. Thrombotic events associated with C1 esterase inhibitor products in patients with hereditary angioedema: investigation from the United States food and drug administration adverse event reporting system database. Pharmacotherapy. 2012;32(10):902–909.
  • Aagaard L, Bygum A. Adverse events reported for hereditary angioedema medications: a retrospective study of spontaneous reports submitted to the EudraVigilance database, 2007–2013. ODRR. 2016;1:1–8.
  • Schürmann D, Herzog E, Raquet E, et al. C1-esterase inhibitor treatment: preclinical safety aspects on the potential prothrombotic risk. Thromb Haemost. 2014;112(5):960–971.
  • Duehrkop C, Banz Y, Spirig R, et al. C1 esterase inhibitor reduces lower extremity ischemia/reperfusion injury and associated lung damage. PLoS One. 2013;8(8):e72059.
  • Horstick G, Berg O, Heimann A, et al. Application of C1-esterase inhibitor during reperfusion of ischemic myocardium: dose-related beneficial versus detrimental effects. Circulation. 2001;104(25):3125–3131.
  • Heydenreich N, Nolte MW, Göb E, et al. C1-inhibitor protects from brain ischemia-reperfusion injury by combined antiinflammatory and antithrombotic mechanisms. Stroke. 2012;43(9):2457–2467.
  • Scherer RU, Giebler RM, Schmidt U, et al. The influence of C1-esterase inhibitor substitution on coagulation and cardiorespiratory parameters in an endotoxin-induced rabbit model of hypercoagulability. Semin Thromb Hemost. 1996;22(4):357–366.
  • Tarandovskiy ID, Buehler PW, Ataullakhanov FI, et al. C1-esterase inhibitor enhances thrombin generation and spatial fibrin clot propagation in the presence of thrombomodulin. Thromb Res. 2019;176:54–60.
  • Tarandovskiy ID, Rajabi AA, Karnaukhova E, et al. Contradictory to its effects on thrombin, C1-inhibitor reduces plasmin generation in the presence of thrombomodulin. J Thromb Thrombolysis. 2019;48(1):81–87.
  • Landsem A, Fure H, Mollnes TE, et al. C1-inhibitor efficiently delays clot development in normal human whole blood and inhibits escherichia coli-induced coagulation measured by thromboelastometry. Thromb Res. 2016;143:63–70.
  • Levy JH, Szlam F, Gelone S. Effects of a plasma-derived C1 esterase inhibitor on hemostatic activation, clot formation, and thrombin generation. Blood Coagul Fibrinolysis. 2014;25(8):883–889.
  • Caccia S, Castelli R, Maiocchi D, et al. Interaction of C1 inhibitor with thrombin on the endothelial surface. Blood Coagul Fibrinolysis. 2011;22(7):571–575.
  • Riedl MA, Bygum A, Lumry W, et al. Safety and usage of C1-inhibitor in hereditary angioedema: Berinert registry data. J Allergy Clin Immunol Pract. 2016;4(5): 963–971.
  • Viglietti D, Gosset C, Loupy A, et al. C1 inhibitor in acute antibody-mediated rejection nonresponsive to conventional therapy in kidney transplant recipients: a pilot study. Am J Transplant. 2016;16(5):1596–1603.
  • Kalaria S, Craig T. Assessment of hereditary angioedema treatment risks. Allergy Asthma Proc. 2013;34(6):519–522.
  • Farkas H, Kőhalmi KV, Veszeli N, et al. Risk of thromboembolism in patients with hereditary angioedema treated with plasma-derived C1-inhibitor. Allergy Asthma Proc. 2016;37(2):164–170.
  • Relan A, Bakhtiari K, van Amersfoort ES, et al. Recombinant C1-inhibitor: effects on coagulation and fibrinolysis in patients with hereditary angioedema. BioDrugs. 2012;26(1):43–52.
  • Bygum A, Martinez-Saguer I, Bas M, et al. Use of a C1 inhibitor concentrate in adults ≥65 years of age with hereditary angioedema: findings from the international berinert® (C1-INH) registry. Drugs Aging. 2016;33(11):819–827.
  • Bernstein JA, Manning ME, Li H, et al. Escalating doses of C1 esterase inhibitor (CINRYZE) for prophylaxis in patients with hereditary angioedema. J Allergy Clin Immunol Pract. 2014;2(1):77–84.
  • Lumry WR, Martinez-Saguer I, Yang WH, et al. Fixed-dose subcutaneous C1-inhibitor liquid for prophylactic treatment of C1-INH-HAE: SAHARA randomized study. J Allergy Clin Immunol Pract. 2019;7(5):1610–1618.e4.
  • Wells PS, Anderson DR, Rodger M, et al. Evaluation of D-dimer in the diagnosis of suspected deep-vein thrombosis. N Engl J Med. 2003;349(13):1227–1235.
  • Baskin JL, Pui C-H, Reiss U, et al. Management of occlusion and thrombosis associated with long-term indwelling central venous catheters. Lancet. 2009;374(9684):159–169.

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