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Evolution of the Thrombolytic Treatment Window for Acute Ischemic Stroke

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      Abstract

      Ischemic stroke is a major cause of morbidity and mortality for which the only approved treatment in the acute setting is intravenous thrombolysis. The efficacy and safety of recombinant tissue plasminogen activator (rt-PA) have been firmly established within 3 h of symptom onset; however, few patients are eligible for treatment in this time window. Expanding the time for treatment has been challenging, but new evidence has demonstrated a modest statistical improvement in selected patients when rt-PA is administered within 4.5 h. This important finding hopefully will enable more patients to receive treatment and simultaneously provides an opportunity to reaffirm that the benefits of rt-PA diminish with time.

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      Most cited references 20

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      Prevalence of overweight and obesity in the United States, 1999-2004.

      The prevalence of overweight in children and adolescents and obesity in adults in the United States has increased over several decades. To provide current estimates of the prevalence and trends of overweight in children and adolescents and obesity in adults. Analysis of height and weight measurements from 3958 children and adolescents aged 2 to 19 years and 4431 adults aged 20 years or older obtained in 2003-2004 as part of the National Health and Nutrition Examination Survey (NHANES), a nationally representative sample of the US population. Data from the NHANES obtained in 1999-2000 and in 2001-2002 were compared with data from 2003-2004. Estimates of the prevalence of overweight in children and adolescents and obesity in adults. Overweight among children and adolescents was defined as at or above the 95th percentile of the sex-specific body mass index (BMI) for age growth charts. Obesity among adults was defined as a BMI of 30 or higher; extreme obesity was defined as a BMI of 40 or higher. In 2003-2004, 17.1% of US children and adolescents were overweight and 32.2% of adults were obese. Tests for trend were significant for male and female children and adolescents, indicating an increase in the prevalence of overweight in female children and adolescents from 13.8% in 1999-2000 to 16.0% in 2003-2004 and an increase in the prevalence of overweight in male children and adolescents from 14.0% to 18.2%. Among men, the prevalence of obesity increased significantly between 1999-2000 (27.5%) and 2003-2004 (31.1%). Among women, no significant increase in obesity was observed between 1999-2000 (33.4%) and 2003-2004 (33.2%). The prevalence of extreme obesity (body mass index > or =40) in 2003-2004 was 2.8% in men and 6.9% in women. In 2003-2004, significant differences in obesity prevalence remained by race/ethnicity and by age. Approximately 30% of non-Hispanic white adults were obese as were 45.0% of non-Hispanic black adults and 36.8% of Mexican Americans. Among adults aged 20 to 39 years, 28.5% were obese while 36.8% of adults aged 40 to 59 years and 31.0% of those aged 60 years or older were obese in 2003-2004. The prevalence of overweight among children and adolescents and obesity among men increased significantly during the 6-year period from 1999 to 2004; among women, no overall increases in the prevalence of obesity were observed. These estimates were based on a 6-year period and suggest that the increases in body weight are continuing in men and in children and adolescents while they may be leveling off in women.
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        Thrombolysis with alteplase 3 to 4.5 hours after acute ischemic stroke.

        Intravenous thrombolysis with alteplase is the only approved treatment for acute ischemic stroke, but its efficacy and safety when administered more than 3 hours after the onset of symptoms have not been established. We tested the efficacy and safety of alteplase administered between 3 and 4.5 hours after the onset of a stroke. After exclusion of patients with a brain hemorrhage or major infarction, as detected on a computed tomographic scan, we randomly assigned patients with acute ischemic stroke in a 1:1 double-blind fashion to receive treatment with intravenous alteplase (0.9 mg per kilogram of body weight) or placebo. The primary end point was disability at 90 days, dichotomized as a favorable outcome (a score of 0 or 1 on the modified Rankin scale, which has a range of 0 to 6, with 0 indicating no symptoms at all and 6 indicating death) or an unfavorable outcome (a score of 2 to 6 on the modified Rankin scale). The secondary end point was a global outcome analysis of four neurologic and disability scores combined. Safety end points included death, symptomatic intracranial hemorrhage, and other serious adverse events. We enrolled a total of 821 patients in the study and randomly assigned 418 to the alteplase group and 403 to the placebo group. The median time for the administration of alteplase was 3 hours 59 minutes. More patients had a favorable outcome with alteplase than with placebo (52.4% vs. 45.2%; odds ratio, 1.34; 95% confidence interval [CI], 1.02 to 1.76; P=0.04). In the global analysis, the outcome was also improved with alteplase as compared with placebo (odds ratio, 1.28; 95% CI, 1.00 to 1.65; P<0.05). The incidence of intracranial hemorrhage was higher with alteplase than with placebo (for any intracranial hemorrhage, 27.0% vs. 17.6%; P=0.001; for symptomatic intracranial hemorrhage, 2.4% vs. 0.2%; P=0.008). Mortality did not differ significantly between the alteplase and placebo groups (7.7% and 8.4%, respectively; P=0.68). There was no significant difference in the rate of other serious adverse events. As compared with placebo, intravenous alteplase administered between 3 and 4.5 hours after the onset of symptoms significantly improved clinical outcomes in patients with acute ischemic stroke; alteplase was more frequently associated with symptomatic intracranial hemorrhage. (ClinicalTrials.gov number, NCT00153036.) 2008 Massachusetts Medical Society
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          Heart disease and stroke statistics--2009 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee.

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            Author and article information

            Affiliations
            University of California, San Diego, Medical Office North, Third Floor, Suite 3, 200 West Arbor Drive, #8466, San Diego, CA 92103 USA
            Contributors
            astemer@ucsd.edu
            Journal
            Curr Neurol Neurosci Rep
            Current Neurology and Neuroscience Reports
            Current Science Inc. (New York )
            1528-4042
            1534-6293
            20 January 2010
            20 January 2010
            January 2010
            : 10
            : 1
            : 29-33
            2828551
            20425223
            76
            10.1007/s11910-009-0076-8
            © The Author(s) 2010
            Categories
            Article
            Custom metadata
            © Springer Science+Business Media, LLC 2010

            Neurosciences

            time window, ischemic stroke, ecass iii, intravenous rt-pa

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