Safety of the weight-adjusted dosing regimen of tenecteplase in the ASSENT-Trial

Am J Cardiol. 2001 Dec 1;88(11):1240-5. doi: 10.1016/s0002-9149(01)02084-7.

Abstract

The results of the ASsessment of Safety and Efficacy of a New Thrombolytic agent (ASSENT-2) trial revealed that tenecteplase (TNK) is equivalent to tissue plasminogen activator (t-PA) for treating myocardial infarction. Because careful consideration of safety is important with all agents, including the newer bolus therapies, and across a range of doses, this study evaluated the safety of TNK compared with t-PA across a range of weight and dose categories. The 5 doses of TNK ranged from 30 to 50 mg and were adjusted for estimated weight. Rates of death and intracranial hemorrhage were determined among patients receiving TNK and t-PA in ASSENT-2, stratified by categories of estimated weight corresponding to each TNK dose. Respective rates of death with TNK versus t-PA were not significantly different in any estimated weight category: <60 kg (12.54% vs 11.46%), 60 to 69 kg (8.22% vs. 8.97%), 70 to 79 kg (5.57% vs 5.48%), 80 to 89 kg (4.66% vs 5.36%), and > or =90 kg (4.91% vs. 3.96%, all p > or =0.26). Respective rates of intracranial hemorrhage were also not significantly different: <60 kg (2.20% vs. 2.29%), 60 to 69 kg (0.97% vs. 1.33%), 70 to 79 kg (1.15% vs. 1.10%), 80 to 89 kg (0.73% vs 0.49%), and > or =90 kg (0.47% vs 0.47%, all p > or =0.33). Adjustment for small baseline differences in this randomized sample did not change the results. Thus, across the range of estimated weight categories corresponding to each TNK dose, TNK is as safe and effective as t-PA.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Body Weight*
  • Double-Blind Method
  • Female
  • Fibrinolytic Agents / administration & dosage*
  • Fibrinolytic Agents / adverse effects
  • Humans
  • Intracranial Hemorrhages / chemically induced
  • Male
  • Middle Aged
  • Myocardial Infarction / drug therapy
  • Safety
  • Tenecteplase
  • Thrombolytic Therapy*
  • Tissue Plasminogen Activator / administration & dosage*
  • Tissue Plasminogen Activator / adverse effects

Substances

  • Fibrinolytic Agents
  • Tissue Plasminogen Activator
  • Tenecteplase