ABSTRACT
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.
Subject(s)
Adverse Drug Reaction Reporting Systems , Drug Monitoring/methods , Myocardial Infarction/chemically induced , Myocardial Infarction/epidemiology , Streptokinase/adverse effects , Aged , Cuba/epidemiology , Female , Humans , Male , Middle Aged , Prospective Studies , Recombinant Proteins/adverse effectsABSTRACT
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. ResultsA total of 1496 suspected ADRs identified in 792 patients out of the 1660 (47.7 percent) prescriptions reported in the program, were received from July 1995 to July 2002. Most of the patients (71.3percent) were male, 67.2percent 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 38percent mild, 38percent moderate, 10 percent severe, and 4percent 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, 95percent 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(AU)
Antecedentes: la estreptoquinasa (SK) es un agente fibrinolítico eficaz para el tratamiento del infarto agudo de miocardio (IAM). El objetivo del presente estudio fue evaluar las reacciones adversas a medicamentos (RAM) se asocia con SK recombinante intravenoso en pacientes con IAM en la práctica clínica habitual. Métodos: Estudio nacional, prospectivo y notificaciones espontáneas de farmacovigilancia basado en el programa se llevó a cabo en Cuba. La demografía del paciente, presuntamente ADR descripción, los elementos para definir la causalidad, y los resultados fueron documentados y analizados. Resultados Un total de 1.496 sospechosos de RAM identificadas en 792 pacientes de los 1.660 (47,7 por ciento) informaron de las recetas en el programa, se recibieron entre julio de 1995 y julio de 2002. La mayoría de los pacientes (71.3percent) eran hombres, eran blancos y 67.2percent edad media fue de 61,6 ± 13,0 años. La media de intervalo de tiempo entre la aparición de los síntomas y el inicio de la infusión de SK fue de 4,9 ± 3,7 h. La RAM más frecuentes fueron hipotensión, arritmias, escalofríos, temblores, vómitos, náuseas, alergias, hemorragias y fiebre. ADR se 38percent gravedad leve, moderada 38percent, el 10 por ciento graves y muy graves 4percent. Sólo 3 pacientes con accidente cerebrovascular hemorrágico se informó. Setenta y dos pacientes fallecieron en el hospital debido principalmente a causas cardíacas asociadas con la del paciente condición clínica subyacente. La mortalidad fue 3 veces más probable en pacientes que sufren arritmias que en aquellos sin este evento (odds ratio: 3.1, 95percent IC: 1,8 a 5,1). La mayoría de los ADR fueron clasificados como posiblemente o probablemente relacionados con la medicación. Conclusión: SK recombinante se asoció con un puesto similar perfil de seguridad de la comercialización a los sugeridos en los ensayos clínicos previos
