Indigenous recombinant streptokinase vs natural streptokinase in acute myocardial infarction patients: Phase III multicentric randomized double blind trial.

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dc.contributor.authorDiwedi, S Ken_US
dc.contributor.authorHiremath, J Sen_US
dc.contributor.authorKerkar, P Gen_US
dc.contributor.authorReddy, Krishna Nen_US
dc.contributor.authorManjunath, C Nen_US
dc.contributor.authorRamesh, S Sen_US
dc.contributor.authorPrabhavati, Sen_US
dc.contributor.authorDhobe, Men_US
dc.contributor.authorSingh, Kavitaen_US
dc.contributor.authorBhusari, Pen_US
dc.contributor.authorRao, Ramanen_US
dc.date.accessioned2005-05-30en_US
dc.date.accessioned2009-05-29T04:22:14Z
dc.date.available2005-05-30en_US
dc.date.available2009-05-29T04:22:14Z
dc.date.issued2005-05-30en_US
dc.description.abstractBACKGROUND: Streptokinase is the most widely used thrombolytic agent and can now be made using recombinant DNA technology. The present trial was initiated to assess an indigenous recombinant streptokinase (Shankinase, r-SK). AIM: To compare the efficacy and safety of indigenous recombinant streptokinase (Shankinase, r-SK) and natural streptokinase (Streptase, n-SK). SETTINGS AND DESIGN: Double blind, randomized, non-inferiority, multicentric, parallel study. MATERIALS AND METHODS: Patients of AMI < 6 hours of chest pain and 2 mm ST elevation in 2 contiguous chest leads V(1)-V(6) or 1 mm in limb leads were randomized to receive 1.5 miu of either r-SK or n-SK. CK Peaking and decrease of > or = 50% ST segment were used to assess reperfusion. STATISTICAL ANALYSIS: Difference in the groups was assessed by chi-square or paired t test as required. Probability value < 0.05 was considered significant with 95% confidence interval. RESULTS: Overall 150 patients were recruited (96 r-SK group and 54 in n-SK group) and demographic and clinical profile of the groups was comparable. Reperfusion was seen in 68.2% (58) and 69.4% (34) patients in r-SK and n-SK groups respectively. Commonly seen adverse events were fever in 7 (8.5%), hypotension in 3 (3.6%), nausea in 2 (2.4%) patients. Minor bleeding were seen in 4 (4.8%) of patients. CONCLUSION: Indigenous recombinant Streptokinase (r-SK) is as efficacious as natural streptokinase (n-SK) in establishing reperfusion as assessed by non-invasive parameters with comparable side effect profile.en_US
dc.description.affiliationDepartment of Cardiology K.G.M.C. Hospital, Lucknow, India.en_US
dc.identifier.citationDiwedi SK, Hiremath JS, Kerkar PG, Reddy KN, Manjunath CN, Ramesh SS, Prabhavati S, Dhobe M, Singh K, Bhusari P, Rao R. Indigenous recombinant streptokinase vs natural streptokinase in acute myocardial infarction patients: Phase III multicentric randomized double blind trial. Indian Journal of Medical Sciences. 2005 May; 59(5): 200-7en_US
dc.identifier.urihttps://imsear.searo.who.int/handle/123456789/66389
dc.language.isoengen_US
dc.source.urihttps://www.indianjmedsci.orgen_US
dc.subject.meshElectrocardiography --drug effectsen_US
dc.subject.meshFemaleen_US
dc.subject.meshFibrinolytic Agents --therapeutic useen_US
dc.subject.meshFollow-Up Studiesen_US
dc.subject.meshHumansen_US
dc.subject.meshMaleen_US
dc.subject.meshMiddle Ageden_US
dc.subject.meshMyocardial Infarction --drug therapyen_US
dc.subject.meshRecombinant Proteins --therapeutic useen_US
dc.subject.meshRetrospective Studiesen_US
dc.subject.meshStreptokinase --therapeutic useen_US
dc.subject.meshThrombolytic Therapyen_US
dc.subject.meshTreatment Outcomeen_US
dc.titleIndigenous recombinant streptokinase vs natural streptokinase in acute myocardial infarction patients: Phase III multicentric randomized double blind trial.en_US
dc.typeClinical Trial, Phase IIIen_US
dc.typeJournal Articleen_US
dc.typeMulticenter Studyen_US
dc.typeRandomized Controlled Trialen_US
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