In a recent clinical trial with recombinant streptokinase (Heberkinasa®), manufactured in Cuba, 86 % efficacy was obtained for prosthetic heart valve thrombosis.
May 21, 2003 (Press Release) --
Encouraging results of a Cuban drug for thrombolytic therapy
Havana-May, 21. Thrombosis is a serious complication of prosthetic heart valves, and management is often difficult. Thrombolytic therapy is a promising alternative to valve reoperation in prosthetic valve thrombosis. In a recent post-marketing clinical trial with recombinant streptokinase (Heberkinasa®), manufactured at the Centre for Genetic Engineering and Biotechnology (Havana, Cuba), 86 % efficacy was obtained for the treatment of prosthetic heart valve thrombosis.
Heberkinasa® is indicated for acute myocardial infarction, deep venous thrombosis, thrombosis of permanent vascular access in patients with hemodialysis-treated chronic renal failure, dysfunction of prosthetic heart valves and intrapleural adherence. Further studies with streptokinase are justified in brain ischaemic stroke since the poorer outcomes in clinical trials with streptokinase than in those with Tissue Plasminogen Activator (t-PA) could be more related to study design than to the active principle (CNS Drug, 2003, 17 (5): 1). The treatment window and the thrombolytic drug dose have been the major differences between clinical trials with streptokinase and t-PA. These aspects could be overcome in a multicentre study.
A greater use of thrombolytics in acute myocardial infarction has been recommended. In Cuba, thrombolysis with Heberkinasa® has been widespread since 1993. When this product was introduced, the overall proportion of patients receiving treatment was a little above 30 %. The management system for patients has, however, become more efficient, with patients arriving earlier. Also, doctors in emergency departments are more acquainted with the product, so currently the rate of thrombolysis is around 50 % and even 70 % in some units (British Medical Journal, 2003, 326: 448, Feb. 22).
Havana-May, 21. Thrombosis is a serious complication of prosthetic heart valves, and management is often difficult. Thrombolytic therapy is a promising alternative to valve reoperation in prosthetic valve thrombosis. In a recent post-marketing clinical trial with recombinant streptokinase (Heberkinasa®), manufactured at the Centre for Genetic Engineering and Biotechnology (Havana, Cuba), 86 % efficacy was obtained for the treatment of prosthetic heart valve thrombosis.
Heberkinasa® is indicated for acute myocardial infarction, deep venous thrombosis, thrombosis of permanent vascular access in patients with hemodialysis-treated chronic renal failure, dysfunction of prosthetic heart valves and intrapleural adherence. Further studies with streptokinase are justified in brain ischaemic stroke since the poorer outcomes in clinical trials with streptokinase than in those with Tissue Plasminogen Activator (t-PA) could be more related to study design than to the active principle (CNS Drug, 2003, 17 (5): 1). The treatment window and the thrombolytic drug dose have been the major differences between clinical trials with streptokinase and t-PA. These aspects could be overcome in a multicentre study.
A greater use of thrombolytics in acute myocardial infarction has been recommended. In Cuba, thrombolysis with Heberkinasa® has been widespread since 1993. When this product was introduced, the overall proportion of patients receiving treatment was a little above 30 %. The management system for patients has, however, become more efficient, with patients arriving earlier. Also, doctors in emergency departments are more acquainted with the product, so currently the rate of thrombolysis is around 50 % and even 70 % in some units (British Medical Journal, 2003, 326: 448, Feb. 22).
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