FDA buys technology that identifies drug toxicity to heart
The University of Rochester Medical Center has a new tool to assess whether a medication might be harmful to the heart. The technology addresses a major health issue – drug toxicity – illustrated most recently by Merck's voluntary withdrawal of Vioxx from the market after concerns that it may cause heart attacks and strokes.
Jean-Philippe Couderc, a biomedical engineer, developed a software program that provides a simpler, more accurate way to analyze the electrocardiograms (EKGs) of people who volunteer for clinical trials to test new drugs. The Food and Drug Administration purchased a copy of the technology, called COMPAS, which stands for Comprehensive Analysis of Repolarization Signal. The university hopes to license the copyrighted software to drug companies and other institutions involved in pre-market drug testing, said John Fahner-Vihtelic, deputy director of the Office of Technology Transfer.
"Our program provides a more reliable method to identify cardiovascular toxicity at a time when the scientific community is diligently seeking ways to address this problem," said Couderc, Ph.D., M.B.A., a research assistant professor in the Cardiology department and assistant director of the Heart Research Follow-up Program. "We are confident that COMPAS will be a valuable tool in the clinical trial and drug development arena."
More comprehensive testing of the heart's reaction to medications is not only important for the success of any new drug, but it became an FDA requirement two years ago. To meet this standard, most companies that design Phase I and II clinical trials require thousands of volunteer subjects to undergo an extensive physical examination, which includes a review of a patient's 24-hour EKG.
The patient's EKG data is loaded onto a computer. Doctors look for abnormalities related to the QT interval. This is the split-second period that occurs from the time a heart beats or contracts, through its recovery phase. Drugs that prolong the recovery phase are of concern, because they can be toxic to the heart.
COMPAS was designed to accurately identify EKG abnormalities, while taking into consideration other factors that may influence a person's heart activity, such as eating, exercise or stress. COMPAS also assesses cardiac drug toxicity by automating the reading process.
Many drugs have been pulled from the market – or the FDA has limited their use – due to the tendency to prolong the QT interval. Usually this occurs, however, after millions of patients have already suffered serious side effects. The list includes antibiotics, weight loss and anti-psychotic medications, heartburn medications, and some cancer and heart disease therapies. (See www.QTdrugs.org for a partial listing.) Therefore, the goal among those who are developing and testing new treatments is to identify the cardiovascular risks to patients at the earliest possible stage.
The Medical Center's Heart Research Follow-up Program is a national and international leader in the science of heart arrhythmias and a rare genetic condition associated with an abnormal QT interval, called the congenital Long QT Syndrome (LQTS). The university keeps an international registry for LQTS, and follows thousands of families who have this inherited condition. The genetic form of the QT prolongation syndrome is similar to the drug-induced syndrome, and Couderc's work focuses on developing the tools to identify individuals with either form.
Source: Eurekalert & othersLast reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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