Dell Medical School at the University of Texas researches stroke medication tenecteplase – Austin American-Statesman

Posted: February 15, 2022 at 5:33 am

New research from the University of Texas Dell Medical School could help change the way strokes are treated.

Dr. Steven Warach, a Dell Medical School neurology professor and director of the stroke program at Ascension Seton hospitals, analyzed the treatment of 9,000 people from 25 stroke networks, including at Ascension Seton hospitals in Austin, as well as hospitals in Los Angeles, North Carolina, New Zealand and Australia.

Warach and his teamlooked at data to see if giving the clot-busting medicationtenecteplase after a stoke instead of the standard medication alteplase ledto any adverse side effects. His team found that people treated with tenecteplase had about 50% fewer hemorrhages as a side effect than people treated with alteplase.

"It's not just as good as, but it's even safer," Warach said.

Waranch is presenting the findings at this week's American Stroke Association's International Stroke Conference in New Orleans.

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The two medications are very similar and even made by the same manufacturer, Genentech, but the newer tenecteplase is a genetically engineered variant of alteplase that can be given more efficiently. Tenecteplase is a five-second injection instead of a one-hour intravenous infusion that alteplase requires.

"It reduced the time it takes to get the medicine into the patient once they arrive at the hospital," Warach said.

With a stroke, there is a 4-hour window from the start of symptoms to get these medications into a patient to minimize the stroke's long-term effects. Classic symptoms for stroke spell out the word FAST: Face drooping or numbness, Arm weakness or inability to equally raise both arms, Speech difficulty (slurring speech, can't speak or difficult to understand), and Time to call 911. Other symptoms include severe headache, numbness or weakness in the leg, confusion, trouble seeing or blurred vision, trouble walking or loss of balance or dizziness.

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Tenecteplaseis also an easier medication to give at surrounding hospitals before a patient can be transferred to a major stroke center for care.

Alteplase has been approved by the U.S. Food and Drug Administration for use with an ischemic stroke, which is the most common type and is caused by a blood clot in the artery blocking blood flow to the brain. Tenecteplase has only been approved for use in breaking up clots after a heart attack.

Warach's researchcan't be used to bring to the FDA for consideration because it's real-world data instead of a clinical trial. Three larger clinical trials are being done now to address efficacy and safetyand are expected to have results in a year or two, Warach said. "I expect they are going to confirm what we have seen in practice," he said.

Warach also has done a cost analysis on the two medications, and he said giving tenecteplase saves about $2,500 from alteplase mainly because of the difference in the cost of the medications. Even though tenecteplase is not FDA authorized for this use, Warach said he has not had any trouble with insurance providers covering it.

Warach said he wanted to do this research of bringing real-world data together so that doctors who have been waiting for more data about the safety of tenecteplase versus alteplase would have it.

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Warach's current study looked at stroke data from July 2018 to June 2021. Ascension Setonhospitals in Austin began using tenecteplase for strokesin September 2019 after looking at data from five smaller studies that found it to be as effective as alteplase at preventing long-term disabilitiesthree months after the stroke.

One study found that when tenecteplase was given in preparation for surgery to remove a blood clot that was causing a stroke, the medication would dissolve the clot on its own. This helped persuade Ascension Seton hospitals to give tenecteplase as an off-label medication for strokes instead of the FDA-approved-for-strokealteplase.

Warach previously put together data from five smallerclinical trials about tenecteplase's use in strokes and presented that research at last year's stroke conference.

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Dell Medical School at the University of Texas researches stroke medication tenecteplase - Austin American-Statesman

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