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Pharmacovigilance program to monitor adverse reactions of recombinant streptokinase in acute myocardial infarction
BACKGROUND: Streptokinase (SK) is an effective fibrinolytic agent for the treatment of acute myocardial infarction (AMI). The objective of the present study was to assess the adverse drug reactions (ADRs) associated with intravenous recombinant SK in patients with AMI in routine clinical practice. M...
Autores principales: | , , , , , , , , , |
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Formato: | Texto |
Lenguaje: | English |
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BioMed Central
2005
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1291362/ https://www.ncbi.nlm.nih.gov/pubmed/16262910 http://dx.doi.org/10.1186/1472-6904-5-5 |
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author | Betancourt, Blas Y Marrero-Miragaya, María A Jiménez-López, Giset Valenzuela-Silva, Carmen García-Iglesias, Elizeth Hernández-Bernal, Francisco Debesa-García, Francisco González-López, Tania Alvarez-Falcón, Leovaldo López-Saura, Pedro A |
author_facet | Betancourt, Blas Y Marrero-Miragaya, María A Jiménez-López, Giset Valenzuela-Silva, Carmen García-Iglesias, Elizeth Hernández-Bernal, Francisco Debesa-García, Francisco González-López, Tania Alvarez-Falcón, Leovaldo López-Saura, Pedro A |
author_sort | Betancourt, Blas Y |
collection | PubMed |
description | BACKGROUND: Streptokinase (SK) is an effective fibrinolytic agent for the treatment of acute myocardial infarction (AMI). The objective of the present study was to assess the adverse drug reactions (ADRs) associated with intravenous recombinant SK in patients with AMI in routine clinical practice. METHODS: A national, prospective and spontaneous reporting-based pharmacovigilance program was conducted in Cuba. Patient demographics, suspected ADR description, elements to define causality, and outcomes were documented and analyzed. RESULTS: A total of 1496 suspected ADRs identified in 792 patients out of the 1660 (47.7 %) prescriptions reported in the program, were received from July 1995 to July 2002. Most of the patients (71.3%) were male, 67.2% were white and mean age was 61.6 ± 13.0 years. The mean time interval between the onset of symptoms and the start of the SK infusion was 4.9 ± 3.7 h. The most frequently reported ADRs were hypotension, arrhythmias, chills, tremors, vomiting, nauseas, allergy, bleeding and fever. ADR severity was 38% mild, 38% moderate, 10% severe, and 4% very severe. Only 3 patients with hemorrhagic stroke were reported. Seventy-two patients died in-hospital mainly because of cardiac causes associated with the patient's underlying clinical condition. Mortality was 3 times more likely in patients suffering arrhythmias than in those without this event (odds ratio 3.1, 95% CI: 1.8 to 5.1). Most of the reported ADRs were classified as possibly or probably associated with the study medication. CONCLUSION: Recombinant SK was associated with a similar post-marketing safety profile to those suggested in previous clinical trials. |
format | Text |
id | pubmed-1291362 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2005 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-12913622005-11-26 Pharmacovigilance program to monitor adverse reactions of recombinant streptokinase in acute myocardial infarction Betancourt, Blas Y Marrero-Miragaya, María A Jiménez-López, Giset Valenzuela-Silva, Carmen García-Iglesias, Elizeth Hernández-Bernal, Francisco Debesa-García, Francisco González-López, Tania Alvarez-Falcón, Leovaldo López-Saura, Pedro A BMC Clin Pharmacol Research Article BACKGROUND: Streptokinase (SK) is an effective fibrinolytic agent for the treatment of acute myocardial infarction (AMI). The objective of the present study was to assess the adverse drug reactions (ADRs) associated with intravenous recombinant SK in patients with AMI in routine clinical practice. METHODS: A national, prospective and spontaneous reporting-based pharmacovigilance program was conducted in Cuba. Patient demographics, suspected ADR description, elements to define causality, and outcomes were documented and analyzed. RESULTS: A total of 1496 suspected ADRs identified in 792 patients out of the 1660 (47.7 %) prescriptions reported in the program, were received from July 1995 to July 2002. Most of the patients (71.3%) were male, 67.2% were white and mean age was 61.6 ± 13.0 years. The mean time interval between the onset of symptoms and the start of the SK infusion was 4.9 ± 3.7 h. The most frequently reported ADRs were hypotension, arrhythmias, chills, tremors, vomiting, nauseas, allergy, bleeding and fever. ADR severity was 38% mild, 38% moderate, 10% severe, and 4% very severe. Only 3 patients with hemorrhagic stroke were reported. Seventy-two patients died in-hospital mainly because of cardiac causes associated with the patient's underlying clinical condition. Mortality was 3 times more likely in patients suffering arrhythmias than in those without this event (odds ratio 3.1, 95% CI: 1.8 to 5.1). Most of the reported ADRs were classified as possibly or probably associated with the study medication. CONCLUSION: Recombinant SK was associated with a similar post-marketing safety profile to those suggested in previous clinical trials. BioMed Central 2005-11-02 /pmc/articles/PMC1291362/ /pubmed/16262910 http://dx.doi.org/10.1186/1472-6904-5-5 Text en Copyright © 2005 Betancourt et al; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( (http://creativecommons.org/licenses/by/2.0) ), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Research Article Betancourt, Blas Y Marrero-Miragaya, María A Jiménez-López, Giset Valenzuela-Silva, Carmen García-Iglesias, Elizeth Hernández-Bernal, Francisco Debesa-García, Francisco González-López, Tania Alvarez-Falcón, Leovaldo López-Saura, Pedro A Pharmacovigilance program to monitor adverse reactions of recombinant streptokinase in acute myocardial infarction |
title | Pharmacovigilance program to monitor adverse reactions of recombinant streptokinase in acute myocardial infarction |
title_full | Pharmacovigilance program to monitor adverse reactions of recombinant streptokinase in acute myocardial infarction |
title_fullStr | Pharmacovigilance program to monitor adverse reactions of recombinant streptokinase in acute myocardial infarction |
title_full_unstemmed | Pharmacovigilance program to monitor adverse reactions of recombinant streptokinase in acute myocardial infarction |
title_short | Pharmacovigilance program to monitor adverse reactions of recombinant streptokinase in acute myocardial infarction |
title_sort | pharmacovigilance program to monitor adverse reactions of recombinant streptokinase in acute myocardial infarction |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1291362/ https://www.ncbi.nlm.nih.gov/pubmed/16262910 http://dx.doi.org/10.1186/1472-6904-5-5 |
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