Efficacy and safety of tenecteplase in Indian elderly STEMI patients from the Elaxim Indian Registry

Indian Heart J. 2011 May-Jun;63(3):234-6.

Abstract

Objective: To analyze the efficacy and safety of indigenous Tenecteplase in Indian elderly STEMI patients in a clinical setting.

Methods: Post-licensure, observational, prescription event monitoring (PEM) study.

Results: 2162 patients received weight-adjusted Tenecteplase injection. The data for elderly (> 60 years) and non-elderly (< or = 60 years) was identified, segregated and compared. Out of 2162 patients, 805 were elderly patients and 1357 were non-elderly. Clinically successful thromolysis was seen in 83.98% of elderly and 86% of non-elderly group (p = 0.22). There was no significant difference in percentage of patients reporting bleeding, stroke, intracranial hemorrhage, myocardial reinfraction, ventricular tachyarrhythmia between the groups. Mortality was significantly (p = < 0.0001) more in elderly (6.21%) than non-elderly (2.06%) patients.

Conclusion: The indigenously developed Tenecteplase shows high efficacy and safety in its in-hospital use in Indian elderly patients with STEMI.

MeSH terms

  • Aged
  • Female
  • Fibrinolytic Agents / therapeutic use*
  • Humans
  • India / epidemiology
  • Male
  • Middle Aged
  • Myocardial Infarction / drug therapy*
  • Myocardial Infarction / epidemiology
  • Product Surveillance, Postmarketing
  • Registries
  • Tenecteplase
  • Tissue Plasminogen Activator / therapeutic use*
  • Treatment Outcome

Substances

  • Fibrinolytic Agents
  • Tissue Plasminogen Activator
  • Tenecteplase