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Boehringer in end 2012 announced the approval in 15 European countries with the mutual recognition procedure, the extent of window treatment with alteplase, rt-PA in cases of acute ischemic stroke within 4 hours of symptom onset and after have ruled out the diagnosis of intracranial hemorrhage. The completion of the regulatory process has been reported by Germany, the Reference Member State, and will allow the implementation of this approval also to the European Union member states that adhere to the mutual recognition procedure. Alteplase is indicated for the fibrinolytic treatment of acute ischemic stroke, or for the dissolution of the clot that has blocked artery, helping to restore the normal blood flow, preventing or limiting damage to ischemic brain tissue. To achieve the greatest possible benefits, treatment should be initiated as early as possible after symptom onset. Alteplase was approved in 1987 for various indications in many countries, and since 1996 for the treatment of ischemic stroke with administration within three hours of the onset of symptoms. The combined analysis of the results of different studies, with placebo control group, showed that treatment with rt-PA within 180 minutes after the onset of ischemic symptoms allows more likely to residuare 30% in less than disability arising from ischemic damage compared to untreated patients or little or no disability after three months of the event compared to patients who did not receive thrombolytic therapy. An official statement by the Italian regulatory agency is likely to be soon released in early 2013. For many Italian hospitals until the official statement of the agency the use of alteplase will not be considered fully appropriate


Microbubbles filled with xenon or other inhert gases as a drug delivery means in acute stroke are periodically reported in medical journals (circulation 2010) or newspapers as the latest frontier. This week the activities of the University College in London and Cincinnati/Houston University raised the attention of scientific journalists see at New Scientist and Daily Mail. But don’t panic this in US was just another experimental animal model. As usual with bubbles also Italians are there.

August 2018
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