Aprotinin revisited.
In 2008, we saw the withdrawal of aprotinin from the US markets after preliminary results from a large, randomized clinical trial in Canada. This drug, a potent antifibrinolytic, was used primarily in complex and/or redo cardiac surgery as an adjunct to decrease postoperative bleeding and complications. The Canadian study raised questions previously brought up in similar studies-does aprotinin increase the risk of mortality and renal failure after cardiac surgery? Recently, a re-review of the Canadian data noted flaws in the study, as well as in the interpretation of the results. The present review revisits the aprotinin controversy.
Department of Cardiothoracic Surgery, NYU-Langone Medical Center, New York, NY, USA. abe.deanda@nyumc.org
Abe
A
Deanda
Bruce D
BD
Spiess
D000933:Antifibrinolytic Agents / Q000009:adverse effects*; D007611:Aprotinin / Q000009:adverse effects*; D006348:Cardiac Surgical Procedures / Q000009:adverse effects* / Q000401:mortality; D019317:Evidence-Based Medicine; D006801:Humans; D018579:Patient Selection; D019106:Postoperative Hemorrhage / Q000209:etiology / Q000517:prevention & control*; D016032:Randomized Controlled Trials as Topic / Q000379:methods; D051437:Renal Insufficiency / Q000139:chemically induced* / Q000401:mortality; D012107:Research Design; D018570:Risk Assessment; D012307:Risk Factors; D056737:Safety-Based Drug Withdrawals; D016896:Treatment Outcome
D000933:Antifibrinolytic Agents; D007611:Aprotinin