| ORIGINAL ARTICLE |
|
| Year : 2005 | Volume
: 59
| Issue : 5 | Page : 200-207 |
Indigenous recombinant streptokinase Vs natural streptokinase in acute myocardial infarction patients: Phase III multicentric randomized double blind trial
SK Diwedi1, JS Hiremath2, PG Kerkar3, Krishna N Reddy4, CN Manjunath5, SS Ramesh6, S Prabhavati5, M Dhobe2, Kavita Singh7, P Bhusari7, Raman Rao7
1 Department of Cardiology K.G.M.C. Hospital, Lucknow, India
2 CCU Ruby Hall Clinic, Pune, India
3 Department of Cardiology KEM Hospital, Mumbai, India
4 CARE Hospital, Hyderabad, India
5 Department of Cardiology, Sri Jayadeva Institute of Cardiology, Bangalore, India
6 Heart Center, Bangalore, India
7 Clinical Research Division, Shantha Biotechnics Ltd., Hyderabad, India
Correspondence Address:
Raman Rao
Clinical Research Division, Serene Chambers, 3rd Floor, Road No.7, Banjara Hills, Hyderabad - 500 034, AP
India
DOI: 10.4103/0019-5359.16256 PMID: 15985728
Background : 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 V1- V6 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 > 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..
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