Document Detail


Deaths associated with platelet glycoprotein IIb/IIIa inhibitor treatment.
MedLine Citation:
PMID:  12695459     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
D L Brown
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Heart (British Cardiac Society)     Volume:  89     ISSN:  1468-201X     ISO Abbreviation:  Heart     Publication Date:  2003 May 
Date Detail:
Created Date:  2003-04-15     Completed Date:  2003-05-09     Revised Date:  2013-06-09    
Medline Journal Info:
Nlm Unique ID:  9602087     Medline TA:  Heart     Country:  England    
Other Details:
Languages:  eng     Pagination:  535-7     Citation Subset:  AIM; IM    
Affiliation:
Division of Cardiovascular Interventions, Beth Israel Medical Center - Dazian 11, First Avenue at 16th Street, New York, NY 10003, USA. dabrown@chpnet.org
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MeSH Terms
Descriptor/Qualifier:
Adult
Adverse Drug Reaction Reporting Systems
Aged
Aged, 80 and over
Angioplasty, Balloon, Coronary
Antibodies, Monoclonal / adverse effects
Death, Sudden / etiology*
Female
Hemorrhage / chemically induced*,  mortality
Humans
Immunoglobulin Fab Fragments / adverse effects
Male
Middle Aged
Myocardial Ischemia / drug therapy
Peptides / adverse effects
Platelet Aggregation Inhibitors / adverse effects*
Platelet Glycoprotein GPIIb-IIIa Complex / antagonists & inhibitors*
Risk Factors
Tyrosine / adverse effects,  analogs & derivatives
Chemical
Reg. No./Substance:
0/Antibodies, Monoclonal; 0/Immunoglobulin Fab Fragments; 0/Peptides; 0/Platelet Aggregation Inhibitors; 0/Platelet Glycoprotein GPIIb-IIIa Complex; 0/eptifibatide; 144494-65-5/tirofiban; 55520-40-6/Tyrosine; X85G7936GV/abciximab
Comments/Corrections
Comment In:
Heart. 2003 May;89(5):477-8   [PMID:  12695441 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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