Safety of aprotinin in heparinized and nonheparinized patients

Abstract

THE PHARMACOLOGIC MANAGEMENT of hemostasis in patients undergoing surgery with or without cardiopulmonary bypass may be accompanied by adverse responses. All hemostatic agents including blood products, lysine analogs, aprotinin, and protamine may be associated with adverse reactions. 1 Levy J.H. Anaphylactic Reactions in Anesthesia and Intensive Care. ed 2. Butterworth-Heinemann, Stoneham1992 Google Scholar The safety profile of aprotinin, a broad-spectrum serine protease inhibitor, has been extensively evaluated in multiple double-blind, placebo-controlled, multicenter studies. 2 Peters D.C. Noble S. Aprotinin An update of its pharmacology and therapeutic use in open heart surgery and coronary artery bypass surgery. Drugs. 1999; 57: 233-260 Crossref PubMed Scopus (122) Google Scholar Although associated with decreased fibrinolysis, aprotinin has not been associated with an increased risk of postcardiopulmonary bypass myocardial infarction, graft closure, stroke, or increased risk of renal dysfunction from US studies. 2 Peters D.C. Noble S. Aprotinin An update of its pharmacology and therapeutic use in open heart surgery and coronary artery bypass surgery. Drugs. 1999; 57: 233-260 Crossref PubMed Scopus (122) Google Scholar , 3 Smith P.K. Datta S.K. Muhlbaier L.H. et al. Cost analysis of aprotinin for coronary artery bypass patients Analysis of the randomized trials. Ann Thorac Surg. 2004; 77 (discussion 642–633): 635-642 Abstract Full Text Full Text PDF PubMed Scopus (31) Google Scholar As with any polypeptide, there is a risk of anaphylaxis, which is influenced not only by prior exposure but also by time since prior exposure. This review will focus on the safety of aprotinin in heparinized and nonheparinized patients.