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Pharmacovigilance program to monitor adverse reactions of recombinant streptokinase in acute myocardial infarction

Blas Y Betancourt1 , María A Marrero-Miragaya2, Giset Jiménez-López3, Carmen Valenzuela-Silva1, Elizeth García-Iglesias1 , Francisco Hernández-Bernal2, Francisco Debesa-García3, Tania González-López1, Leovaldo Alvarez-Falcón1, Pedro A López-Saura1 and the Cuban National Network of Pharmacoepidemiology4

Blas Y Betancourt1 , María A Marrero-Miragaya2, Giset Jiménez-López3, Carmen Valenzuela-Silva1, Elizeth García-Iglesias1 , Francisco Hernández-Bernal2, Francisco Debesa-García3, Tania González-López1, Leovaldo Alvarez-Falcón1, Pedro A López-Saura1 and the Cuban National Network of Pharmacoepidemiology4

1Clinical Trials Division, Center for Biological Research, Havana, Cuba

2National Center for Clinical Trials Coordination, Havana, Cuba

3National Coordinating Unit of Pharmacovigilance, Centre for the Development of Pharmacoepidemiology, Minister of Heath, Havana, Cuba

4A list of the National Network of Pharmacoepidemiology participating investigators appears in the Appendix

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.

BMC Clinical Pharmacology , 5:5 doi:10.1186/1472-6904-5-5

© Betancourt et al; licensee BioMed Central Ltd.

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