Comparative Efficacy and Safety of Reteplase Versus Alteplase in Ischemic Stroke
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Reviewed & Translated by Dat Tien Nguyen, B.A, ScM.
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Posted on August 19th, 2024
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Thrombolytic agents like tenecteplase and alteplase are standard treatments for ischemic stroke. Reteplase, another plasminogen activator known for its double-bolus administration, has been approved in many countries for treating myocardial infarction. A study sponsored by China Resources Angde Biotech Pharma compared the effectiveness of reteplase with alteplase in treating ischemic stroke.
The phase 3 clinical trial involved 707 patients hospitalized for ischemic stroke within 4.5 hours of study enrollment. Participants were randomly assigned to receive either alteplase or reteplase. Alteplase was administered as a single intravenous dose of 0.9 mg per kilogram, while reteplase was given in two intravenous doses of 18 mg, separated by 30 minutes. Patient outcomes were evaluated using the 6-point modified Rankin scale, where higher scores indicate greater severity. At baseline, over 90% of patients had the lowest severity score of 0, with the remainder scoring 1 or 2. A follow-up assessment at 90 days post-treatment showed that reteplase outperformed alteplase by 9.4%, as measured by the percentage of patients achieving a score of 0 or 1 on the modified Rankin scale. Additionally, more patients treated with reteplase showed significant recovery at both 7 days and 24 hours. However, clinicians should be aware that reteplase slightly increases the risk of intracranial hemorrhage within 90 days post-treatment by 2.8% compared to alteplase. The researchers also cautioned that the study's findings might not be fully generalizable, as women and individuals over the age of 80 were underrepresented in the sample.
The phase 3 clinical trial involved 707 patients hospitalized for ischemic stroke within 4.5 hours of study enrollment. Participants were randomly assigned to receive either alteplase or reteplase. Alteplase was administered as a single intravenous dose of 0.9 mg per kilogram, while reteplase was given in two intravenous doses of 18 mg, separated by 30 minutes. Patient outcomes were evaluated using the 6-point modified Rankin scale, where higher scores indicate greater severity. At baseline, over 90% of patients had the lowest severity score of 0, with the remainder scoring 1 or 2. A follow-up assessment at 90 days post-treatment showed that reteplase outperformed alteplase by 9.4%, as measured by the percentage of patients achieving a score of 0 or 1 on the modified Rankin scale. Additionally, more patients treated with reteplase showed significant recovery at both 7 days and 24 hours. However, clinicians should be aware that reteplase slightly increases the risk of intracranial hemorrhage within 90 days post-treatment by 2.8% compared to alteplase. The researchers also cautioned that the study's findings might not be fully generalizable, as women and individuals over the age of 80 were underrepresented in the sample.