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Pfizer contributes critical data to URMC drug safety initiative
Date:1/12/2009

y (HIPPA) regulations.

"We are glad and thankful that Pfizer has chosen the THEW platform for sharing their data with the international scientific community'" said Jean-Philippe Couderc, Ph.D., director of the THEW initiative. "We believe the global strategy of our initiative, its legal framework, and the support received from the Food and Drug Administration have played key roles in the development of successful collaboration with companies like Pfizer."

The Pfizer data will be housed in THEW and will enable researchers to develop new tools to detect drugs that may have dangerous effects on the heart. The Pfizer data will consist of several important sets of ECGs from different phases of a study of a drug that did not reach the market because of its adverse effect of the process of cardiac ventricular repolarization the split-second period between the heart's contraction and recovery phase. If a drug prolongs the repolarization process, then it is generally believed to heighten the risk for adverse cardiac events, such as dangerous arrhythmias and heart attacks.

Sudden cardiac arrest is the leading cause of death in the United States, resulting in more than 450,000 deaths per year. Included in this number are deaths caused by drugs that trigger a predisposition to lethal cardiac arrhythmias or even the drugs themselves. As part of FDA's regulatory review process, the agency requires evidence of a drug's impact on the QT interval as one way to assess the cardiac risk associated with new compounds. The QT interval is a segment of an ECG recording that measures the process of ventricular repolarization. Prolongation of the QT interval associated with episodes of fatal ventricular arrhythmias is a leading cause of removal of drugs from the market and was a leading impetus toward international collaboration to develop specialized studies to monitor the QT prolongation effects of new drugs. The THEW project is part of this initiative.
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Contact: Mark Michaud
mark_michaud@urmc.rochester.edu
585-273-4790
University of Rochester Medical Center
Source:Eurekalert

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