Alteplase may raise angiodema risk for certain stroke patients: Study
Researchers suggest using another medication to dissolve blood clots
Stroke patients treated with alteplase, a medication used to dissolve blood clots, are at an increased risk of developing angioedema, a retrospective study has found.
Being female, using ACE or angiotensin-converting enzyme inhibitors, and having high blood pressure were all identified as “significant risk factors for angioedema among alteplase-treated stroke patients,” according to the researchers.
Tenecteplase, another medication used as a thrombolytic therapy, or to dissolve blood clots, “could be considered as an alternative treatment, particularly for those with identified risk factors,” the team wrote.
The study, “Risk of angioedema and thrombolytic therapy among stroke patients: An analysis of data from the FDA Adverse Event Reporting System database,” was published in the journal Neurotherapeutics.
Investigating angioedema risk linked to alteplase, tenecteplase use
Angioedema is the medical term for swelling in the deeper layers of the skin, or in the membranes lining the respiratory and gastrointestinal tracts.
Past reports have indicated that the risk of angioedema is higher for patients prescribed thrombolytic agents — such as alteplase — which broadly work to break down or dissolve blood clots. Alteplase is sold as Activase and Cathflo Activase.
Indeed, as many as 7.9% of patients treated with alteplase experience angioedema at some point, previous studies have estimated.
However, whether this risk varies depending on the type of thrombolytic agent used remains unknown.
To know more, researchers in China retrospectively analyzed data from stroke patients recorded in the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database.
Data from a total of 17,776 stroke patients, spanning from 2013 to 2023, were included. The patients had a mean age of 69.6, and were nearly evenly divided by sex. Among them, 2,973 received alteplase and 278 were treated with tenecteplase, another thrombolytic agent marketed as TNKase.
Hypertension or high blood pressure was the most common coexisting condition, or comorbidity, seen in these patients (27.4%); beta-blockers were the most commonly prescribed medications to lower blood pressure (21.9%). ACE inhibitors and angiotensin II receptor blockers (ARBs), which have been previously linked to angioedema, also had been used for that purpose, the data showed.
The analysis revealed that 21.8% of patients treated with alteplase and 19.8% of those treated with tenecteplase developed angioedema.
According to the researchers, the data “suggested a probable causal relationship between alteplase and angioedema, whereas there was insufficient evidence of a probable causal relationship with tenecteplase.”
In a statistical analysis, alteplase use was associated with a 5.13 times greater risk of developing angioedema, even after adjusting for multiple potential confounding factors. These included age, sex, ACE inhibitor use, high blood pressure, high blood sugar, and high levels of fats in the bloodstream.
The same analysis, meanwhile, revealed a 2.72 times higher risk of angioedema associated with the use of tenecteplase.
[The data] suggested a probable causal relationship between alteplase and angioedema, whereas there was insufficient evidence of a probable causal relationship with tenecteplase.
A time-to-onset analysis showed that angioedema tended to occur early following the start of treatment with alteplase. In the case of tenecteplase, angioedema occurred randomly at any stage of treatment.
Further analyses examining risk factors for angioedema showed that the use of ACE inhibitors, being female, and having high blood pressure were predictors of an increased risk of angioedema among stroke patients treated with alteplase. In the case of tenecteplase, potential risk factors for angioedema included having high blood sugar levels and using ACE inhibitors.
Researchers urge clinicians to be ‘vigilant’ for life-threatening complications
Overall, according to the researchers, these findings provide evidence suggestive that “alteplase is associated with a greater risk of angioedema among stroke patients.”
However, given the limited number of tenecteplase-treated patients, “there is insufficient evidence to support an association between tenecteplase and angioedema,” the researchers wrote.
The team noted, however, that “clinicians should be vigilant for this potentially life-threatening complication, particularly in patients with identified risk factors,” and that “it is also prudent to consider tenecteplase as an alternative, if available.”
While tenecteplase is a potential alternative, if “not available, careful monitoring during alteplase administration is imperative given its established association with angioedema,” the researchers wrote.
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