The thrombogenicity of C1 esterase inhibitor (human): Review of the evidence

Allergy and Asthma Proceedings

Volumn 35, Issue 6, 2014, Pages 444-453

  Crowther, Mark ^a   Bauer, Kenneth A ^b   Kaplan, Allen P ^c  

^a MCMASTER UNIVERSITY   (Canada)

^b BETH ISRAEL DEACONESS MEDICAL CENTER   (United States)

^c MEDICAL UNIVERSITY OF SOUTH CAROLINA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

COMPLEMENT COMPONENT C1S INHIBITOR;

ANGIONEUROTIC EDEMA; BLOOD CLOTTING; BRAIN ISCHEMIA; CAPILLARY LEAK SYNDROME; CEREBROVASCULAR ACCIDENT; DEEP VEIN THROMBOSIS; FIBRINOLYSIS; HEART FUNCTION; HEART INFARCTION; HEMOSTASIS; HUMAN; IN VIVO STUDY; JUGULAR VEIN THROMBOSIS; LUNG EMBOLISM; LUNG FUNCTION; MEDLINE; NONHUMAN; OFF LABEL DRUG USE; PARTIAL THROMBOPLASTIN TIME; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL (TOPIC); REPERFUSION INJURY; REVIEW; RISK FACTOR; SEPSIS; ST SEGMENT ELEVATION MYOCARDIAL INFARCTION; THROMBOEMBOLISM; THROMBOGENICITY; TRANSIENT ISCHEMIC ATTACK; VEIN THROMBOSIS; ANGIOEDEMAS, HEREDITARY; ANIMAL; BLOOD; CHEMICALLY INDUCED; COMPLICATION; DISEASE MODEL; DRUG EFFECTS; INCIDENCE; META ANALYSIS; THROMBOSIS;

ANGIOEDEMAS, HEREDITARY; ANIMALS; BLOOD COAGULATION; COMPLEMENT C1 INHIBITOR PROTEIN; DISEASE MODELS, ANIMAL; HUMANS; INCIDENCE; RISK FACTORS; THROMBOSIS;

EID: 84910604258     PISSN: 10885412     EISSN: 15396304     Source Type: Journal    
DOI: 10.2500/aap.2014.35.3799     Document Type: Review

References (57)

1. Zeerleder S. C1-inhibitor: More than a serine protease inhibitor. Semin Thromb Hemost 37:362-374, 2011.
2. Zuraw BL. Clinical practice. Hereditary angioedema. N Engl J Med 359:1027-1036, 2008.
3. Cicardi M, Aberer W, Banerji A, et al, on behalf of HAWK (Hereditary Angioedema International Working Group) under the patronage of EAACI (European Academy of Allergy and Clinical Immunology). Classification, diagnosis, and approach to treatment for angioedema: Consensus report from the Hereditary Angioedema International Working Group. Allergy 69:602-616, 2014.
4. Birnbaum J, Klotz E, Spies CD, et al. The combinations C1 esterase inhibitor with coagulation factor XIII and N-acetylcysteine with tirilazad mesylate reduce the leukocyte adherence in an experimental endotoxemia in rats. Clin Hemorheol Microcirc 40:167-176, 2008.
5. Birnbaum J, Klotz E, Spies CD, et al. Impact of combined C1 esterase inhibitor/coagulation factor XIII or N-acetylcysteine/ tirilazad mesylate administration on leucocyte adherence and cytokine release in experimental endotoxaemia. J Int Med Res 36:748-759, 2008.
6. Cai S, and Davis AE III. Complement regulatory protein C1 inhibitor binds to selectins and interferes with endothelial-leukocyte adhesion. J Immunol 171:4786-4791, 2003.
7. Zhang H, Qin G, Liang G, et al. Suppression of complement regulatory protein C1 inhibitor in vascular endothelial activation by inhibiting vascular cell adhesion molecule-1 action. Biochem Biophys Res Commun 358:1120-1127, 2007.
8. Levi M, Roem D, Kamp AM, et al. Assessment of the relative contribution of different protease inhibitors to the inhibition of plasmin in vivo. Thromb Haemost 69:141-146, 1993.
9. CSL Behring LLC. Berinert prescribing information. Kankakee, IL ; 2012. (Last accessed February 2014).
10. ViroPharma Biologics, Inc. Cinryze prescribing information. Exton, PA; 2014. (Last accessed March 2014).
11. Feussner A, Kalina U, Hofmann P, et al. Biochemical comparison of four commercially available C1 esterase inhibitor concentrates for treatment of hereditary angioedema. Transfusion 2014. Epub ahead of print May 8, 2014. doi: 10.1111/trf.12678.
12. Buehler PW. www.fda.gov/downloads/BiologicsBloodVaccines/ BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/ Fractionated PlasmaProducts/UCM229783.pdf.
13. 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 104:3125-3131, 2001.
14. Drug Commission of the German Medical Profession. Serious thrombogenesis following Berinert HS. Dtsch Arztebl 97:A- 1016, 2000.
15. Gandhi PK, Gentry WM, and 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 32:902-909, 2012.
16. Baig K, Nassar R, Craig DM, et al. Complement factor 1 inhibitor improves cardiopulmonary function in neonatal cardiopulmonary bypass. Ann Thorac Surg 83:1477-1482, 2007.
17. Duehrkop C, Banz Y, Spirig R, et al. C1 esterase inhibitor reduces lower extremity ischemia/reperfusion injury and associated lung damage. PLoS One 8:e72059, 2013.
18. Heydenreich N, Nolte MW, Göb E, et al. C1-inhibitor protects from brain ischemia-reperfusion injury by combined antiin-flammatory and antithrombotic mechanisms. Stroke 43:2457-2467, 2012.
19. Horstick G, Heimann A, Götze O, et al. Intracoronary application of C1 esterase inhibitor improves cardiac function and reduces myocardial necrosis in an experimental model of ischemia and reperfusion. Circulation 95:701-708, 1997.
20. Lu F, Fernandes SM, and Davis AE III. The effect of C1 inhibitor on myocardial ischemia and reperfusion injury. Cardiovasc Pathol 22:75-80, 2013.
21. Salvatierra A, Velasco F, Rodriguez M, et al. C1-esterase inhibitor prevents early pulmonary dysfunction after lung transplantation in the dog. Am J Respir Crit Care Med 155:1147-1154, 1997.
22. Fattouch K, Bianco G, Speziale G, et al. Beneficial effects of C1 esterase inhibitor in ST-elevation myocardial infarction in patients who underwent surgical reperfusion: A randomised dou-ble- blind study. Eur J Cardiothorac Surg 32:326-332, 2007.
23. Thielmann M, Marggraf G, Neuha?user M, et al. Administration of C1-esterase inhibitor during emergency coronary artery bypass surgery in acute ST-elevation myocardial infarction. Eur J Cardiothorac Surg 30:285-293, 2006.
24. de Zwaan C, Kleine AH, Diris JH, et al. Continuous 48-h C1- inhibitor treatment, following reperfusion therapy, in patients with acute myocardial infarction. Eur Heart J 23:1670-1677, 2002.
25. Caliezi C, Zeerleder S, Redondo M, et al. C1-inhibitor in patients with severe sepsis and septic shock: Beneficial effect on renal dysfunction. Crit Care Med 30:1722-1728, 2002.
26. Igonin AA, Protsenko DN, Galstyan GM, et al. C1-esterase inhibitor infusion increases survival rates for patients with sepsis. Crit Care Med 40:770-777, 2012.
27. Hack CE, Voerman HJ, Eisele B, et al. C1-esterase inhibitor substitution in sepsis. Lancet 339:378, 1992.
28. Tassani P, Kunkel R, Richter JA, et al. Effect of C1-esteraseinhibitor on capillary NOT leak and inflammatory response syndrome during arterial switch operations in neonates. J Cardiothorac Vasc Anesth 15:469-473, 2001.
29. Nü rnberger W, Heying R, Burdach S, and Göbel U. C1 esterase inhibitor concentrate for capillary leakage syndrome following bone marrow transplantation. Ann Hematol 75:95-101, 1997.
30. Ogilvie AC, Baars JW, Eerenberg AJ, et al. A pilot study to evaluate the effects of C1 esterase inhibitor on the toxicity of high-dose interleukin 2. Br J Cancer 69:596-598, 1994.
31. Herzog E, Schuermann D, Raquet E, et al. Berinert (C1-esterase inhibitor concentrate) treatment is not associated with prothrombotic risk based on preclinical efficacy and safety investigations- .Poster Presentation at the 2013 annual meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI), San Antonio, TX, February 22-26, 2013.
32. 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 2:77-84, 2014.
33. Levy J, Szlam F, and Gelone S. An ex vivo evaluation of the hemostatic effects of plasma-derived C1 inhibitor. Presented at the XXIV Congress of the International Society on Thrombosis and Haemostasis, Amsterdam, The Netherlands, June 29-July 4, 2013. Available online at www.eventure-online.com/eventure/ publicAbstractView.do?id=213980&congressId=6839; accessed December 27, 2013.
34. Zuraw BL, and Kalfus I. Safety and efficacy of prophylactic nanofiltered C1-inhibitor in hereditary angioedema. Am J Med 125:938.e1-7, 2012.
35. Zuraw B. Pharmacokinetics of C1 esterase inhibitor in hereditary angioedema subjects. http://clinicaltrials.gov/ct2/show/ NCT00432510. (Last accessed March 2014).
36. Zuraw BL, Busse PJ, White M, et al. Nanofiltered C1 inhibitor concentrate for treatment of hereditary angioedema. N Engl J Med 363:513-522, 2010.
37. Riedl MA, Hurewitz DS, Levy R, et al. Nanofiltered C1 esterase inhibitor (human) for the treatment of acute attacks of hereditary angioedema: An open-label trial. Ann Allergy Asthma Immunol 108:49-53, 2012.
38. Craig TJ, Levy RJ, Wasserman RL, et al. Efficacy of human C1 esterase inhibitor concentrate compared with placebo in acute hereditary angioedema attacks. J Allergy Clin Immunol 124: 801-808, 2009.
39. Craig TJ, Bewtra AK, Bahna SL, et al. C1 esterase inhibitor concentrate in 1085 hereditary angioedema attacks: Final results of the I.M.P.A.C.T. 2 study. Allergy 66:1604-1611, 2011.
40. Farkas H, Jakab L, Temesszentandra?si G, et al. Hereditary angioedema: A decade of human C1-inhibitor concentrate therapy. J Allergy Clin Immunol 120:941-947, 2007.
41. Coppola L, Guastafierro S, Verrazzo G, et al. C1 inhibitor infusion modifies platelet activity in hereditary angioedema patients. Arch Pathol Lab Med 126:842-845, 2002.
42. Cugno M, Zanichelli A, Bellatorre AG, et al. Plasma biomarkers of acute attacks in patients with angioedema due to C1-inhibitor deficiency. Allergy 64:254-257, 2009.
43. Cugno M, Cicardi M, Bottasso B, et al. Activation of the coagulation cascade in C1-inhibitor deficiencies. Blood 89:3213-3218, 1997.
44. Cugno M, Hack CE, de Boer JP, et al. Generation of plasmin during acute attacks of hereditary angioedema. J Lab Clin Med 121:38-43, 1993.
45. Joseph K, Tholanikunnel TE, and Kaplan AP. Treatment of episodes of hereditary angioedema with C1 inhibitor: Serial assessment of observed abnormalities of the plasma brady-kinin- forming pathway and fibrinolysis. Ann Allergy Asthma Immunol 104:50-54, 2010.
46. Relan A, Bakhtiari K, van Amersfoort ES, et al. Recombinant C1-inhibitor: Effects on coagulation and fibrinolysis in patients with hereditary angioedema. BioDrugs 26:43-52, 2012.
47. 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 167:472-478, 2012.
48. Nussberger J, Cugno M, and Cicardi M. Bradykinin-mediated angioedema. N Engl J Med 347:621-622, 2002.
49. Wessler S, Reimer SM, and Sheps MC. Biologic assay of a thrombosis-inducing activity in human serum. J Appl Physiol 14:943-946, 1959.
50. Vassalli JD, Sappino AP, and Belin D. The plasminogen activator/ plasmin system. J Clin Invest 88:1067-1072, 1991.
51. Bate A, Lindquist M, Edwards IR, et al. A Bayesian neural network method for adverse drug reaction signal generation. Eur J Clin Pharmacol 54:315-321, 1998.
52. Norén GN, Bate A, Orre R, and Edwards IR. Extending the methods used to screen the WHO drug safety database towards analysis of complex associations and improved accuracy for rare events. Stat Med 25:3740-3757, 2006.
53. van Puijenbroek EP, Bate A, Leufkens HG, et al. A comparison of measures of disproportionality for signal detection in spontaneous reporting systems for adverse drug reactions. Pharmacoepidemiol Drug Saf 11:3-10, 2002.
54. Kucher N. Clinical practice. Deep-vein thrombosis of the upper extremities. N Engl J Med 364:861-869, 2011.
55. Kalaria S, and Craig T. Assessment of hereditary angioedema treatment risks. Allergy Asthma Proc 34:519-522, 2013.
56. Smith D, Gilbert M, and Owen WG. Tissue plasminogen activator release in vivo in response to vasoactive agents. Blood 66:835-839, 1985.
57. Feng D, Syed IS, Martinez M, et al. Intracardiac thrombosis and anticoagulation therapy in cardiac amyloidosis. Circulation 119: 2490-2497, 2009.