TITLE

Efficacy and safety of i.v. alteplase therapy up to 4.5 hours after acute ischemic stroke onset

AUTHOR(S)
Otwell, Jenna L.; Phillippe, Haley M.; Dixon, Kelly S.
PUB. DATE
July 2010
SOURCE
American Journal of Health-System Pharmacy;7/1/2010, Vol. 67 Issue 13, p1070
SOURCE TYPE
Academic Journal
DOC. TYPE
Article
ABSTRACT
Purpose. The efficacy and safety of i.v. alteplase up to 4.5 hours after acute ischemic stroke (AIS) onset were evaluated. Summary. Stroke is the leading cause of disability in the elderly, and i.v. alteplase (recombinant tissue plasminogen activator) is the only Food and Drug Administration (FDA)-approved thrombolytic agent for the treatment of AIS. Alteplase has been shown to decrease the percentage of patients disabled by a stroke. Until recently, the use of alteplase was only recommended within 3 hours of the onset of AIS symptoms. However, two clinical trials published in 2008 demonstrated that therapy with i.v. alteplase remains safe and effective when given 3-4.5 hours after AIS onset. Although FDA has not yet approved expanding the time interval to 4.5 hours for treatment with i.v. alteplase, the American Stroke Association recently published a statement recommending administration of alteplase in eligible patients 3-4.5 hours after symptom onset. There is clinical evidence supporting the safety and efficacy of i.v. alteplase administration to eligible patients who present within 4.5 hours of AIS symptom onset. Treatment with alteplase decreases the likelihood of disability from an AIS and is not associated with an increased rate of mortality. Expanding the time window for treatment with alteplase would likely increase the percentage of AIS patients who are able to receive alteplase and thus ultimately decrease the percentage of those left disabled from an AIS. Conclusion. Evidence supports the safety and efficacy of i.v. alteplase administration to eligible patients within 4.5 hours of AIS symptom onset.
ACCESSION #
51474034

 

Related Articles

  • Alteplase Approved for Treatment in Stroke.  // American Family Physician;9/15/1996, Vol. 54 Issue 4, p1397 

    Reports that in 1996, the United States Food and Drug Administration approved the use of alteplase for the management of acute ischemic stroke in adults. Effectiveness of the tissue plasminogen activator; Effect on neurologic recovery and incidence of disability; Program to educate public about...

  • IMAGING DEPARTMENT. When Every Second Counts. Hagland, Mark // Healthcare Informatics;Dec2009, Vol. 26 Issue 12, p31 

    The article focuses on the development of telemedicine programs for the diagnosis and treatment of strokes. It mentions the use of the clot-busting drug tissue plasminogen activator (tPA) which was approved by the U.S. Food and Drug Administration for stroke care in 1996. It states tPA needs to...

  • t-PA FOR TREATING ACUTE ISCHEMIC STROKE. Shaughnessy, Allen S.; Scow, Dean Thomas // Journal of Family Practice;May96, Vol. 42 Issue 5, p458 

    The article discusses research being done on the use of tissue plasminogen activator (t-PA) for treating acute ischemic stroke. It references a study by the National Institute of Neurological Disorders and Stroke t-PA Stroke Study Group published in a 1995 issue of "The New England Journal of...

  • FDA Advisory Decision Highlights Some Problems Inherent in Pragmatic Trials. Mitka, Mike // JAMA: Journal of the American Medical Association;11/2/2011, Vol. 306 Issue 17, p1851 

    The article discusses the vote of a majority of members of the U.S. Food and Drug Administration's (FDA) Cardiovascular and Renal Drugs Advisory Committee to recommend the approval of the oral antithrombin, rivaroxaban, as an alternative treatment for stroke for patients with atrial...

  • Timely dose.  // U.S. News & World Report;7/01/96, Vol. 121 Issue 1, p62 

    Tells that the United States Food and Drug Administration has approved the drug t-PA to dissolve the blood clots which cause most strokes. Marketed by Genentech as Activase; The amount by which the drug increased complete patient recovery in a National Institutes of Health study.

  • Combination Anti-Stroke Drug May Be Better Protection for Some.  // FDA Consumer;Mar/Apr2000, Vol. 34 Issue 2, p4 

    Reports on the approval of the United States Food and Drug Administration on an anti-stroke treatment, Aggrenox. Efficacy; Side effects.

  • EPITHET Results Show Efficacy of t-PA Beyond the Three-Hour Stroke Treatment Window. Dziedzic, Jessica // Neurology Reviews;Apr2008, Vol. 16 Issue 4, p10 

    The article reports on the result of the Echoplanar Imaging Thrombolysis Evaluation Trial (EPITHET) which reveals that the use of tissue plasminogen activator (t-PA) in the extended treatment period has led to a significantly increased reperfusion. Stephen M. Davis has stressed that the EPITHET...

  • Time to End America's Drug Lag. Klein, Daniel B.; Tabarrok, Alexander // Consumers' Research Magazine;Apr2002, Vol. 85 Issue 4, p10 

    Deals with the factors that affect the effectiveness of drugs to cure diseases in the U.S. Role of the U.S. Food and Drug Administration (FDA) in the marketing of drugs; Information on a cost-benefit study of the FDA wrote by Sam Peltzman; Comparison of the drug availability and safety of drugs...

  • Letter from Chicago: Nonsenserine. Doner, George // BMJ: British Medical Journal (International Edition);7/27/91, Vol. 303 Issue 6796, p253 

    Addresses the apprehensions on the efficacy of Nonsenserine, a drug developed in the United States. Approval of the drug by the Food and Drug Administration; Variations of the drug; Cost of the drug.

Share

Read the Article

Courtesy of VIRGINIA BEACH PUBLIC LIBRARY AND SYSTEM

Sorry, but this item is not currently available from your library.

Try another library?
Sign out of this library

Other Topics