MONDAY, Oct. 26 (HealthDay News) -- The tissue plasminogen activator alteplase leads to better outcomes in stroke patients even when administered more than three hours after onset of symptoms, according to a study published online Oct. 21 in The Lancet Neurology.
Erich Bluhmki, Ph.D., of Boehringer Ingelheim in Biberach, Germany, and colleagues performed secondary analyses of data from the European Cooperative Acute Stroke Study III (ECASS III), which tested alteplase against placebo. The study focused on 821 patients with acute ischemic stroke randomized to receive either intravenous alteplase or placebo 3.0 to 4.5 hours after symptom onset. Previously published research from ECASS III showed that alteplase is superior to placebo in this window. In this study, the authors used different end points to confirm or refute the efficacy and safety outcomes in the primary analysis.
Although results were not significant in every analysis, the researchers report a clear trend in favor of alteplase. Among subgroups, alteplase was found effective in older patients independent of stroke severity. Risk of intracranial hemorrhage was independent of time from symptoms to treatment, but not independent of age (less than 65 years, odds ratio, 0.74); 65 years and older, odds ratio, 5.79).
"Our results support the use of alteplase up to 4.5 hours after the onset of stroke symptoms across a broad range of subgroups of patients who meet the requirements of the European product label but miss the approved treatment window of zero to three hours," the authors write.
Three of the study authors are employees of Boehringer Ingelheim, which sponsored the study. The remainder of the authors have received honoraria, consulting and lecture fees from Boehringer Ingelheim.
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