t-PA in Stroke: New Look at NINDS Data

Sat, 7 Dec 2002 22:58:40 -0800 (PST)

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FYI... A long awaited look at the NINDS data for TPA and stroke. 

-----Original Message-----

From: AAEM [mailto:info@aaem.org]

Subject: t-PA in Stroke: New Look at NINDS Data

To AAEM members,

This is the NINDS release about the new group taking a second look at the data from the positive trial of t-PA in stroke. AAEM will follow the results of this group's evaluation carefully and keep you informed on this issue.

NINDS NOTES

October 2002

The NINDS recently invited an independent committee to review and consider the data from the five-year, multi-site "Tissue Plasminogen Activator for Acute Ischemic Stroke," published by the NINDS r-TPA Stroke Study Group in the New England Journal of Medicine, December 14, 1995. The study represents the first treatment for acute ischemic stroke, and the therapeutic agent t-PA was approved by the FDA for this usage in June of 1996.

In recent months, public debate about the study findings has resulted in some discussion within the medical community about the appropriate use of this treatment for stroke. In answer to this, the NINDS asked that the committee "address whether there is concern that eligible stroke patients may not benefit from rt-PA given according to the protocol used in the (NINDS) trials, and whether any subgroup imbalances invalidate the trial as claimed by some of the critics."

The committee is chaired by W. Michael O'Fallon, Ph.D., Professor of Biostatistics and former Chair at the Department of Health Sciences Research at the Mayo Clinic, in Rochester, Minnesota, and a recent past president of the American Statistical Association. 

Dr. O'Fallon chose the members of the committee, who represent an international cadre of physician-scientists with expertise in biostatistics, clinical medicine, cerebrovascular disease, neurology, and emergency medicine. None of the committee members has a connection with the previous published study or with the manufacturer of t-PA. (See the roster of the committee members below.)

The committee has full access to the study data, will re-analyze the study, and hopes to report its findings by early spring. The NINDS looks forward to the group's findings and the presentation of the data analysis at professional meetings and in the scientific literature.

Roster

W. Michael O'Fallon, PhD, Chair

Professor of Biostatistics

Mayo Clinic

Timothy J Ingall MB BS, PhD

Associate Professor of Neurology

Cerebrovascular Diseases Center

Mayo Clinic Scottsdale

Professor Thomas A. Louis, PhD

Department of Biostatistics

Johns Hopkins Bloomberg School of Public Health

Lewis R. Goldfrank, MD

Director, Emergency Medicine

Bellevue Hospital Center

Professor, Clinical Medicine and Surgery

New York University School of Medicine

Kjell Asplund, MD, PhD

Head, Department of Medicine

University Hospital

Umea, Sweden

Vicki Stover Hertzberg, Ph.D.

Associate Professor

Department of Biostatistics

Emory University

AAEM

611 East Wells Street

Milwaukee, WI 53202

800-884-2236

Fax: 414-276-3349

E-mail: info@aaem.org

Website: www.aaem.org

Brian Potts
Managing Editor, CAL/AAEM News Service
MS-IV, UC Irvine
MD/MBA candidate
pottsbri@yahoo.com

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<FONT size=2>
<P>FYI... A long awaited look at the NINDS data for TPA and stroke. </P>
<P>-----Original Message-----</P>
<P>From: AAEM [</FONT><A href="mailto:info@aaem.org"><U><FONT color=#0000ff size=2>mailto:info@aaem.org</U></FONT></A><FONT size=2>]</P>
<P>Subject: t-PA in Stroke: New Look at NINDS Data</P>
<P>&nbsp;</P>
<P>To AAEM members,</P>
<P>This is the NINDS release about the new group taking a second look at the data from the positive trial of t-PA in stroke. AAEM will follow the results of this group's evaluation carefully and keep you informed on this issue.</P>
<P>NINDS NOTES</P>
<P>October 2002</P>
<P>The NINDS recently invited an independent committee to review and consider the data from the five-year, multi-site "Tissue Plasminogen Activator for Acute Ischemic Stroke," published by the NINDS r-TPA Stroke Study Group in the New England Journal of Medicine, December 14, 1995. The study represents the first treatment for acute ischemic stroke, and the therapeutic agent t-PA was approved by the FDA for this usage in June of 1996.</P>
<P>In recent months, public debate about the study findings has resulted in some discussion within the medical community about the appropriate use of this treatment for stroke. In answer to this, the NINDS asked that the committee "address whether there is concern that eligible stroke patients may not benefit from rt-PA given according to the protocol used in the (NINDS) trials, and whether any subgroup imbalances invalidate the trial as claimed by some of the critics."</P>
<P>The committee is chaired by W. Michael O'Fallon, Ph.D., Professor of Biostatistics and former Chair at the Department of Health Sciences Research at the Mayo Clinic, in Rochester, Minnesota, and a recent past president of the American Statistical Association. </P>
<P>Dr. O'Fallon chose the members of the committee, who represent an international cadre of physician-scientists with expertise in biostatistics, clinical medicine, cerebrovascular disease, neurology, and emergency medicine. None of the committee members has a connection with the previous published study or with the manufacturer of t-PA. (See the roster of the committee members below.)</P>
<P>The committee has full access to the study data, will re-analyze the study, and hopes to report its findings by early spring. The NINDS looks forward to the group's findings and the presentation of the data analysis at professional meetings and in the scientific literature.</P>
<P>Roster</P>
<P>W. Michael O'Fallon, PhD, Chair</P>
<P>Professor of Biostatistics</P>
<P>Mayo Clinic</P>
<P>&nbsp;</P>
<P>Timothy J Ingall MB BS, PhD</P>
<P>Associate Professor of Neurology</P>
<P>Cerebrovascular Diseases Center</P>
<P>Mayo Clinic Scottsdale</P>
<P>&nbsp;</P>
<P>Professor Thomas A. Louis, PhD</P>
<P>Department of Biostatistics</P>
<P>Johns Hopkins Bloomberg School of Public Health</P>
<P>&nbsp;</P>
<P>Lewis R. Goldfrank, MD</P>
<P>Director, Emergency Medicine</P>
<P>Bellevue Hospital Center</P>
<P>Professor, Clinical Medicine and Surgery</P>
<P>New York University School of Medicine</P>
<P>&nbsp;</P>
<P>Kjell Asplund, MD, PhD</P>
<P>Head, Department of Medicine</P>
<P>University Hospital</P>
<P>Umea, Sweden</P>
<P>&nbsp;</P>
<P>Vicki Stover Hertzberg, Ph.D.</P>
<P>Associate Professor</P>
<P>Department of Biostatistics</P>
<P>Emory University</P>
<P>&nbsp;</P>
<P>AAEM</P>
<P>611 East Wells Street</P>
<P>Milwaukee, WI 53202</P>
<P>800-884-2236</P>
<P>Fax: 414-276-3349</P>
<P>E-mail: info@aaem.org</P>
<P>Website: </FONT><A href="http://us.f207.mail.yahoo.com/ym/www.aaem.org"><U><FONT color=#0000ff size=2>www.aaem.org</U></FONT></A><FONT size=2></P></FONT><BR><BR>Brian Potts<br>Managing Editor, CAL/AAEM News Service<br>MS-IV, UC Irvine<br>MD/MBA candidate<br>pottsbri@yahoo.com<p><br><hr size=1>Do you Yahoo!?<br>
<a href="http://rd.yahoo.com/mail/mailsig/*http://mailplus.yahoo.com">Yahoo! Mail Plus</a> - Powerful. Affordable. <a href="http://rd.yahoo.com/mail/mailsig/*http://mailplus.yahoo.com">Sign up now</a>
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