Prospects of Tenecteplase Use for Ischemic Stroke in Evidence-Based Approach

Authors

  • O. R. Levytska Danylo Halytsky Lviv National Medical University, Lviv, Ukraine,
  • B. Р. Hromovyk Danylo Halytsky Lviv National Medical University, Lviv, Ukraine,
  • G. M. Pryshlyak Communal City Clinical Hospital of Ambulance, Lviv, Ukraine,

DOI:

https://doi.org/10.14739/2409-2932.2018.2.133489

Keywords:

stroke, thrombolytic therapy, tenecteplase

Abstract

Оne of the modern evidence-based methods for treating patients with ischemic stroke is systemic thrombolytic therapy. Only alteplase is allowed for systemic thrombolytic therapy. But this medical drug have restriction to use and a number of serious complications. It causes the need for research other medicines for thrombolysis treating. One of these drugs can be tenecteplase.

The aim of work.To research and generalize evidential data on the use of tenecteplase, as well as to assess its benefits in thrombolytic therapy for ischemic stroke.

Materials and methods. Materials: systematic reviews, results of meta-analyses and clinical trials. Methods: information search, analysis and synthesis, and graphical and mathematical evaluation.

Results. One systematic review, two meta-analyses, and five completed clinical trials were singled out from the Database of Research into Stroke (DORIS) and the Medline database of the National Medical Library of the United States, as well as from clinical trial databases. These findings were utilized to summarize evidential data for tenecteplase use with ischemic stroke. The graphical and mathematical evaluation revealed that according to the following indicators: 24 hour recanalization, functional results after 3 months, benefit/risk ratio, administration method, fibrin-selectivity, half-life and resistance to the inhibitor of the type 1 plasminogen activator, tenecteplase is superior to alteplase, however in terms of the cost the former is inferior to the latter. Competitiveness coefficient of tenecteplase is 4.3 times higher than the one of alteplase.

Conclusions. Based on the chosen comparison criteria, tenecteplase has significant advantages over alteplase and therefore may be used as its likely alternative, given almost similar safety profile and effectiveness, as well as better usability. To confirm or refute this, further large-scale clinical trials are required.

 

 

References

The European Stroke Organisation (ESO) Executive Committee and the ESO Writing Committee (2008) Guidelines for Management of Ischaemic Stroke and Transient Ischaemic Attack 2008. Cerebrovasc Dis., 25(5), 457–507. doi: 10.1159/000131083.

Powers, W. J., Rabinstein, A. A., Ackerson, T., Adeoye, O. M., Bambakidis, N. C., Becker, K., et al. (2018). AHA/ASA Guideline.2018 Guidelines for the Early Management of Patients With Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke, 49, eXXX–eXXX. doi: 10.1161/STR.0000000000000158.

(2012) Unifikovanyi klinichnyi protokol medychnoi dopomohy. Systemnyi trombolizys pry ishemichnomu insulti (ekstrena, vtorynna (spetsializovana) medychna dopomoha [Unified clinical protocol for medical care. Systemic thrombolysis with ischemic stroke (emergency, secondary (specialized) medical aid]. Retrived from http://mtd.dec.gov.ua/images/dodatki/2012_602/2012_602dod3ykpmd.pdf [in Ukrainian].

Gilyarov, M. Yu. & Konstantinova, E. V. (2014). Novyye vozmozhnosti i perspektivy primeneniya tenekteplazy v reperfuzionnoj terapii bol'nykh s infarktom miokarda i bol'nykh s ishemicheskim insul'tom [New possibilities and prospects for the use of tenecteplase in reperfusion therapy of patients with myocardial infarction and patients with ischemic stroke]. Russkij medicinskij zhurnal «Medicinskoe obozrenie», 31, 2181–2185. [in Russian].

Zhu, L. N., Chen, D., Chen, T., Lin, Y., Xu, D. & Liu, L. (2016). Efficacy and safety of rt-PA intravenous thrombolysis for treating acute ischemic stroke beyond the therapeutic window: a Meta-analysis. Chinese Journal of Contemporary Neurology and Neurosurgery, 16(2), 64–70. doi: 10.3969 / j.issn.1672-6731.2016.02.002.

Zozulia, I. & Martynchuk, Yu. (2013). Efektyvnist zastosuvannia trombolitychnoi terapii pry ishemichnomu tserebralnomu insultii [Efficacy of thrombolic therapy in case of ischemic cerebral stroke]. Zbirnyk naukovykh prats spivrobitnykiv NMAPO imeni P.L. Shupyka, 22(2), 85–98. [in Ukrainian].

(2014) Unifikovanyi klinichnyi protokol ekstrenoi, pervynnoi, vtorynnoi (spetsializovanoi) ta tretynnoi (vysokospetsializovanoi) medychnoi dopomohy ta medychnoi reabilitatsii. Hostryi koronarnyi syndrom z elevatsiieiu sehmenta ST [Unified clinical protocol of emergency, primary, secondary (specialized) andtertiary (highly specialized) medical careand medical rehabilitation. Acute coronary syndrome with segment elevation ST]. Retrived from http://old.moz.gov.ua/docfiles/dod455_ukp_2014.pdf. [in Ukrainian].

Davydov, L. & Cheng, J. W. (2001). Tenecteplase: a review. Clin. Ther., 23(7), 982–997. doi: 10.1016/S0149-2918(01)80086-2 •

Haley, E. C. Jr., Lyden, P. D., Johnston, K. C., & Hemmen, T. M. (2005). A pilot dose-escalation safety study of tenecteplase in acute ischemic stroke. Stroke, 36(3), 607–612. doi: 10.1161/01.STR.0000154872.73240.e9.

Parsons, M., Spratt, N., Bivard, A., Campbell, B., Chung, K., Miteff, F., et al. (2012). A Randomized trial of tenecteplase versus alteplase for acute ischemic stroke. N Engl J Med., 366(12), 1099–1107. doi: 10.1056/NEJMoa1109842.

Belkouch, A., Jidane, S., Chouaib, N., Elbouti, A., Nebhani, T., Sirbou, R., et al. (2015). Thrombolysis for acute ischemic stroke tenecteplase in the emergency department of a Moroccan hospital. PanAfrMed J., 21, 37. doi: 10.11604/pamj.2015.21.37.6491.

Logallo, N., Novotny, V., Assmus, J., Kvistad, C. E., Alteheld, L., Ronning, O. M., et al. (2017). Tenecteplase versus alteplase for management of acute ischaemic stroke (NOR-TEST): a phase 3, randomised, open-label, blinded endpoint trial. Lancet Neurol., 16(10), 781–788. doi: 10.1016/S1474-4422(17)30253-3.

Behrouz, R. (2014). Intravenous tenecteplase in acute ischemic stroke: An updated review. J Neurol., 261(6), 1069–1072. doi: 10.1007/s00415-013-7102-0.

Glasziou, P. P., Del Mar, C. & Salisbury, J. (2003). Evidence-based medicine workbook: Finding and applying the best research evidence to improve patient care. London: BMJ Books.

Hromovyk, B. P. (2003). Metody nahliadnoho analizu v marketynhovo-lohistychnykh doslidzhenniakh farmatsevtychnykh pidpryiemstv [Methods of visual analysis in marketing and logistics researches of pharmaceutical companies: methodical recommendations]. Lviv. [in Ukrainian].

Coutts, S. B., Dubuc, V., Mandzia, J., Kenney, C., Demchuk, A. M., Smith, E. E., et al. (2015). Tenecteplase-tissue-type plasminogen activator evaluation for minor ischemic stroke with proven occlusion. Stroke, 46(3), 769–74. doi: 10.1161/STROKEAHA.114.008504.

Tsivgoulis, G., Alleman, J., Barreto, A. D., Molina, C. A., & Alexandrov, A. V. (2014) Comparative efficacy of different acute reperfusion therapies for acute ischemic stroke: a comprehensive meta-analysis of clinical trials. Stroke, 45, A77.

Mandava, P., Sarma, A. K., Shah, S. D. & Kent, Т. А. (2014). A severity-adjusted systematic analysis demonstrates a 3 hour ceiling to improve upon iv rt-PA. Cerebrovascular Diseases, 37(1), 27.

Huang, X., MacIsaac, R., Thompson, J. L., Levin, B., Buchsbaum, R., Haley, E. C. et al. (2016). Tenecteplase versus alteplase in stroke thrombolysis: An individual patient data meta-analysis of randomized controlled trials. International Journal of Stroke, 11(5), 534–543. doi: 10.1177/1747493016641112.

Bivard, A., Huang, X., Levi, C. R., Spratt, N., Campbell, B. C. V., Cheripelli, B. K., et al. (2017). Tenecteplase in ischemic stroke offers improved recanalization: Analysis of 2 trials. Neurology, 89(1), 62–67. doi: 10.1212/WNL.0000000000004062.

Penumbral Based Novel Thrombolytic Therapy in Acute Ischemic Stroke (TIAS). Clinical Trials.gov. Retrived from https://clinicaltrials.gov/ct2/show/study/NCT02101606

Kate, M., Wannamaker, R., Kamble, H., Riaz, P., Gioia, L. C., Buck, B., et al. (2018). 1. Penumbral Imaging-Based Thrombolysis with Tenecteplase Is Feasible up to 24 Hours after Symptom Onset. Journal of Stroke, 20(1), 122–130. doi: 10.5853/jos.2017.00178.

Pharmbase. Retrived from http://pharmbase.com.ua/

How to Cite

1.
Levytska OR, Hromovyk BР, Pryshlyak GM. Prospects of Tenecteplase Use for Ischemic Stroke in Evidence-Based Approach. Current issues in pharmacy and medicine: science and practice [Internet]. 2018Jun.20 [cited 2024Jul.20];(2). Available from: http://pharmed.zsmu.edu.ua/article/view/133489

Issue

Section

Review