by COLLEEN CREAMER
For VerusMed
New data reveal that intravenous treatment with Boehringer Ingelheim GmbH’s Actilyse (alteplase) administered between three and four and a half hours after the onset of symptoms can significantly improve outcomes in patients with acute ischemic stroke.
Actilyse, which Genentech Inc. markets as Activase in the United States, is approved for administration within three hours following the onset of symptoms of acute ischemic stroke.
In the double-blind ECASS 3 trial, which was designed to assess the safety and efficacy of the drug beyond the approved three-hour window, patients were randomized to receive 0.9 mg/kg of body weight of Actilyse (n=418) or placebo (n=403) with a median time to treatment initiation of three hours 59 minutes for the active treatment.
The primary endpoint of the study was disability at 90 days. A score of 0 or 1 on the modified Rankin scale was considered a favorable outcome, and a score of 2 to 6 was considered an unfavorable outcome. The secondary endpoint was a global outcome analysis of four neurologic and disability scores combined.
For the primary endpoint, 52.4 percent of the patients treated with Actilyse and 45.2 percent of those treated with placebo had a favorable outcome. This translated into a significant 34 percent increase in the odds of having a favorable outcome with Actilyse relative to placebo.
In the global outcome analysis, the odds of a favorable outcome, which was the ability to return to an independent lifestyle after stroke, were a significant 28 percent higher for the patients treated with Actilyse as compared with the placebo group.
Safety data demonstrated a significantly higher incidence of intracranial hemorrhage with Actilyse as compared with placebo (27 percent vs. 17.6 percent, respectively), which was consistent with findings from earlier studies. Additional safety data revealed that mortality was not significantly different between the Actilyse and placebo groups (7.7 percent and 8.4 percent, respectively), and that there was no significant difference in the rate of other serious adverse events.
“Early treatment remains the cornerstone of acute stroke therapy, and it is of paramount importance that patients arriving in stroke units who are eligible for thrombolysis should be treated without delay. However, the new ECASS 3 data show that stroke can be effectively managed also in patients who are unable to reach a stroke center within three hours,” said Dr. Werner Hacke, the study’s lead investigator.
These data were presented in Vienna, Austria, at the 6th World Stroke Congress and were published in the Sept. 25 issue of The New England Journal of Medicine.
The study was sponsored by Boehringer Ingelheim.
This information concerns a use that has not been approved by the Food and Drug Administration.
