Comparable mortality, stroke, and intracranial hemorrhage (ICH) rates in GUSTO III trial* |
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Mortality rate at 30 days was comparable between Retavase and alteplase groups |
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Mortality rate at 1 year was comparable between Retavase and alteplase groups |
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Rates of any stroke or hemorrhagic stroke at 30 days were comparable between Retavase and alteplase groups |
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Contraindications |
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Bleeding is the most common complication of fibrinolytic therapy. Because fibrinolytics increase the risk of bleeding, Retavase is contraindicated in the following situations: |
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Active internal bleeding |
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History of cerebrovascular accident |
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Recent intracranial or intraspinal surgery or trauma (see "Warnings" in PI) |
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Intracranial neoplasm, arteriovenous malformation, or aneurysm |
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Known bleeding diathesis |
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Severe uncontrolled hypertension |
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*Global Use of Strategies to Open Occluded Arteries (GUSTO III) trial, a multicenter, randomized trial comparing 30-day mortality in patients treated with Retavase (n=10,138) or accelerated alteplase (n=4921). One-year mortality rates were ascertained in 9885 Retavase patients and 4789 alteplase patients in a follow-up study. |
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†Patients ≤75 years of age. |
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Important Safety Information |
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Because thrombolytic therapy increases the risk of bleeding, including internal bleeding (such as intracranial, retroperitoneal, gastrointestinal, genitourinary, or respiratory), Retavase should be used only in those patients for whom its use is indicated in the prescribing information
(see "Indications" in the prescribing information). In addition, thrombolytic therapy increases the absolute risk of stroke, including hemorrhagic stroke, in patients of advanced age. Cholesterol embolism has been reported rarely in patients treated with thrombolytic agents. Coronary thrombolysis may result in arrhythmias associated with reperfusion (see "Warnings" in the prescribing information). |
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