D L Brown1. 1. Division of Cardiovascular Interventions, Beth Israel Medical Center - Dazian 11, First Avenue at 16th Street, New York, NY 10003, USA. dabrown@chpnet.org
Abstract
BACKGROUND: The glycoprotein (GP) IIb/IIIa inhibitors are potent antagonists of platelet aggregation that are approved to prevent thrombotic complications of percutaneous coronary intervention and for medical treatment of patients with acute coronary ischaemic syndromes. From safety data obtained from clinical trials, these agents appear to be associated with a definite but well tolerated increase in non-fatal bleeding complications. However, the bleeding risk of patients enrolled in clinical trials may not be representative of the population actually being treated with these agents. OBJECTIVE: To conduct a review of the adverse events related to GP IIb/IIIa inhibitors reported to the Food and Drug Administration (FDA). METHODS: 450 reports of death related to treatment with GP IIb/IIIa inhibitors were submitted to the FDA between 1 November 1997 and 31 December 2000. These were reviewed and a standard rating system for assessing causation was applied to each event. RESULTS: Of the 450 deaths, 44% were considered to be definitely or probably related to the use of GP IIb/IIIa inhibitors. The mean age of patients who died was 69 years and 47% of deaths occurred in women. All of the deaths deemed to be definitely or probably related to GP IIb/IIIa inhibitor treatment were associated with excessive bleeding. The central nervous system was the most common site of fatal bleeding. CONCLUSIONS: Treatment with GP IIb/IIIa inhibitors may result in fatal bleeding complications in some patients. These findings suggest that patients treated in normal clinical practice may be at greater risk than those treated in clinical trials. Judicious use of these agents is therefore appropriate.
BACKGROUND: The glycoprotein (GP) IIb/IIIa inhibitors are potent antagonists of platelet aggregation that are approved to prevent thrombotic complications of percutaneous coronary intervention and for medical treatment of patients with acute coronary ischaemic syndromes. From safety data obtained from clinical trials, these agents appear to be associated with a definite but well tolerated increase in non-fatal bleeding complications. However, the bleeding risk of patients enrolled in clinical trials may not be representative of the population actually being treated with these agents. OBJECTIVE: To conduct a review of the adverse events related to GP IIb/IIIa inhibitors reported to the Food and Drug Administration (FDA). METHODS: 450 reports of death related to treatment with GP IIb/IIIa inhibitors were submitted to the FDA between 1 November 1997 and 31 December 2000. These were reviewed and a standard rating system for assessing causation was applied to each event. RESULTS: Of the 450 deaths, 44% were considered to be definitely or probably related to the use of GP IIb/IIIa inhibitors. The mean age of patients who died was 69 years and 47% of deaths occurred in women. All of the deaths deemed to be definitely or probably related to GP IIb/IIIa inhibitor treatment were associated with excessive bleeding. The central nervous system was the most common site of fatal bleeding. CONCLUSIONS: Treatment with GP IIb/IIIa inhibitors may result in fatal bleeding complications in some patients. These findings suggest that patients treated in normal clinical practice may be at greater risk than those treated in clinical trials. Judicious use of these agents is therefore appropriate.
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