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

Abstract

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 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.

• Authors: S K Diwedi, J S Hiremath, P G Kerkar, Krishna N Reddy, C N Manjunath, S S Ramesh, S Prabhavati, M Dhobe, Kavita Singh, P Bhusari, Raman Rao
• Journal: Indian journal of medical sciences (Indian J Med Sci) Vol. 59 Issue 5 Pg. 200-7 (May 2005) ISSN: 0019-5359 [Print] India
• PMID: 15985728 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Fibrinolytic Agents
• Recombinant Proteins
• Streptokinase

Topics

• Electrocardiography (drug effects)
• Female
• Fibrinolytic Agents (therapeutic use)
• Follow-Up Studies
• Humans
• Male
• Middle Aged
• Myocardial Infarction (drug therapy, physiopathology)
• Recombinant Proteins (therapeutic use)
• Retrospective Studies
• Streptokinase (therapeutic use)
• Thrombolytic Therapy
• Treatment Outcome