Tenecteplase compares favorably to alteplase in new comparison of FDA-approved stroke drugs
Tenecteplase, a new drug that just gained U.S. Food and Drug Administration (FDA) approval for treating acute ischemic stroke (AIS) in adults, is associated with short-term safety and effectiveness outcomes that are similar to alteplase, according to new findings published in JAMA Network Open.[1]
Tenecteplase is a clot-dissolving drug sold and marketed by Genentech under the brand name TNKase. It is only the second drug of its kind to gain FDA approval. The first was alteplase, which Genentech sells and markets under the brand name Activase.
Tenecteplase, designed to be a much easier treatment option than alteplase, is given to patients through a single five-second intravenous bolus. Alteplase, meanwhile, is administered by giving patients an IV bolus that is then followed by a 60-minute infusion.
To learn more about how these clot-busting drugs compare with each other, researchers tracked data from nearly 80,000 AIS patients. The mean age was 68.6 years old, and 48.5% of patients were women. All patients underwent intravenous thrombolysis from July 2020 to June 2022.
While 88.1% of patients were treated with alteplase, the remaining 11.9% were treated with tenecteplase. The study’s primary endpoint was functional independence at the time of discharge, and secondary effectiveness endpoints included free of disability at discharge, discharged home and independent ambulation at discharge. Safety endpoints, on the other hand, included symptomatic intracranial hemorrhage within 36 hours and a combination of in-hospital mortality or hospice discharge.
Overall, the authors found, “no significant differences were found” between the newly approved tenecteplase and alteplase. The group also found that tenecteplase was associated with certain benefits over alteplase when treating patients eligible for endovascular thrombectomy (EVT) who do not undergo EVT due to clinical improvement following thrombolysis, advanced age or “patient or family refusal.” Among these patients, the authors explained, tenecteplase improved the patient’s odds of being discharged to their own home and reduced their odds of in-hospital mortality.
“This study supports tenecteplase as a reasonable alternative to alteplase, with practical advantages for tenecteplase preparation and administration,” wrote first author Justin F. Rousseau, MD, MMSc, a specialist with the department of neurology at the University of Texas Southwestern Medical Center, and colleagues. “As the adoption of tenecteplase increases across stroke center types, geographic regions, and stroke characteristics, future research will provide additional insight into whether small but clinically important differences in outcomes between tenecteplase and alteplase exist.”
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Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.