Alteplase

(Activase®)

Alteplase

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Drug updated on 5/22/2024

Dosage FormInjection (intravenous; 50 mg, 100 mg)
Drug ClassTissue plasminogen activators
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of Acute Ischemic Stroke (AIS).
  • Indicated for the treatment of Acute Myocardial Infarction (AMI) to reduce mortality and incidence of heart failure.
  • Indicated for the treatment of Acute Massive Pulmonary Embolism (PE) for lysis.

Summary
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  • Alteplase (Activase) is indicated for the treatment of Acute Ischemic Stroke (AIS), Acute Myocardial Infarction (AMI), and Acute Massive Pulmonary Embolism (PE).
  • A total of 17 systematic reviews/meta-analyses provided comparative analyses between Tenecteplase and Alteplase.
  • The evidence suggests that both drugs have similar efficacy in improving clinical outcomes in patients with AIS. However, some studies suggest that Tenecteplase may be slightly more effective at early vessel recanalization and excellent recovery.
  • Safety profiles do not significantly differ between the two drugs. Both carry risks associated with symptomatic intracerebral hemorrhage and mortality; however, certain patient subsets might experience a higher risk of intracranial hemorrhage when treated with Tenecteplase.
  • Dosing considerations indicate that a 0.25 mg/kg dosage of Tenecteplase could offer better or equivalent outcomes compared to the standard 0.9 mg/kg dose of Alteplase concerning early neurological improvement and recanalization rates.
  • Subgroup analysis reveals nuanced differences in outcomes such as early recanalization rates favoring Tenecteplase among patients with tandem occlusions. Certain patient groups on ACE inhibitors or those having specific comorbidities may have differential risks or outcomes emphasizing personalized treatment considerations.
  • Evidence from studies underlines that while both drugs are viable options for treating AIS, ongoing debates exist regarding optimal dosing strategies, especially within varying time windows post-stroke onset considering different stroke severities.
  • Tenecteplase's potential effectiveness in achieving early recanalization has been highlighted as an area requiring further investigation within tailored therapeutic strategies.

Product Monograph / Prescribing Information

Document TitleYearSource
Activase (alteplase) Prescribing Information.2022Genentech, Inc., South San Francisco, CA

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Tenecteplase versus alteplase for the treatment of acute ischemic stroke: a meta-analysis of randomized controlled trials.2024Annals of Medicine
Tenecteplase versus alteplase for acute ischemic stroke: a systematic review and meta-analysis of randomized and non-randomized studies.2024Journal of Neurology
Tenecteplase versus alteplase in acute ischemic stroke: a systematic review and meta-analysis.2024Annals of Neurosciences
Efficacy and safety outcomes of Tenecteplase versus Alteplase for thrombolysis of acute ischemic stroke: a meta-analysis of 9 randomized controlled trials.2024Journal of the Neurological Sciences
Intravenous thrombolysis with tenecteplase versus alteplase combined with endovascular treatment of anterior circulation tandem occlusions: a pooled analysis of ETIS and TETRIS.2024European Stroke Journal
The efficacy and safety of intravenous thrombolysis with tenecteplase versus alteplase for acute ischemic stroke: a systematic review and meta-analysis.2023Neurological Sciences
Tenecteplase vs. alteplase for treatment of acute ischemic stroke: a systematic review and meta-analysis of randomized trials.2023Frontiers in Neurology
Tenecteplase vs. alteplase for intravenous thrombolytic therapy of acute ischemic stroke: a systematic review and meta-analysis.2023Neurology and Therapy
The efficacy and safety of tenecteplase versus alteplase for acute ischemic stroke: an updated systematic review, pairwise, and network meta-analysis of randomized controlled trials.2023Journal of Thrombosis and Thrombolysis
Comparative efficacy and safety of tenecteplase and alteplase in acute ischemic stroke: a pairwise and network meta-analysis of randomized controlled trials.2023Journal of the Neurological Sciences
Different doses of tenecteplase vs. alteplase for acute ischemic stroke within 4.5 hours of symptom onset: a network meta-analysis of randomized controlled trials.2023Frontiers in Neurology
Tenecteplase vs. alteplase for acute ischemic stroke: a systematic review.2022International Journal of Emergency Medicine
Tenecteplase vs. alteplase for acute ischemic stroke: a systematic review.2022International Journal of Emergency Medicine
Tenecteplase vs. alteplase for the treatment of patients with acute ischemic stroke: a systematic review and meta-analysis.2022Journal of Neurology
The safety and effectiveness of early anti-platelet therapy after alteplase for acute ischemic stroke: a meta-analysis.2021Journal of Clinical Neuroscience
Related factors with orolingual angioedema after intravenous alteplase in acute ischemic stroke: results from a single-center cohort and meta-analysis.2021Neurological Sciences
Safety and efficacy of repeated thrombolysis with alteplase in early recurrent ischemic stroke: a systematic review.2019Journal of Stroke & Cerebrovascular Diseases

Clinical Practice Guidelines