SARASOTA (Nov. 1, 2012) – Sarasota Memorial Hospital announced today that it has been selected by Iverson Genetic Diagnostics as a study site for its FDA-approved WARFARIN Study (Warfarin Adverse Event Reduction for Adults Receiving Genetic Testing at Therapy Initiation).
The clinical trial is under way in 55 major hospital systems nationwide to determine whether genetic testing can be used to personalize individual patients’ warfarin doses and reduce their risk of serious bleeding or clotting events.
The most commonly prescribed blood thinner in the world, Warfarin causes up to 100,000 serious and unnecessary adverse events every year, including thousands of deaths. The medication is difficult to dose as patients respond to it differently based on their genetic makeup – too much warfarin can result in severe bleeding, while too little can cause clot formation and increased risk of stroke.
Studies have shown that DNA testing can potentially improve the safety and effectiveness of warfarin, said Kirk Voelker, M.D., medical director of Sarasota Memorial’s Clinical Research Center and principal investigator of the Sarasota study. The drug is prescribed to 2 million patients in the U.S. annually and approximately 20 million Americans in total are taking it.
“In the past, warfarin dosing relied on trial-and-error, which exposed patients to serious medical risks,” said Dr. Voelker, a researcher and physician helping Sarasota Memorial build its Institute of Personalized Medicine. “Using genetic testing to guide physicians in starting warfarin therapy has the potential to reduce dosing complications, and also lower healthcare costs.”
Given the magnitude of these potential improvements in warfarin use, the Centers for Medicare & Medicaid Services (CMS) has authorized the WARFARIN Study to gather data on the potential impact of a pharmacogenetic test to reduce serious bleeding and clotting episodes in patients.
Upon review of the Study, the first such personalized medicine trial authorized by CMS, the agency may establish reimbursement for the genetic warfarin test, which is marketed by Iverson Genetic Diagnostics.
"This landmark study is about more than warfarin," said Dean Sproles, CEO and Chairman, Iverson Genetic Diagnostics, Inc., which initiated the WARFARIN Study. "It is about individualizing treatment to improve patient safety and outcomes, thereby reducing healthcare costs. CMS' support of the WARFARIN Study demonstrates their commitment to exploring the impact of genetic testing on individualized dosing, which may pave the way for other studies in the personalized medicine arena."
About the WARFARIN Study
- Researchers have identified two specific genes, VKORC1 (for warfarin sensitivity) and CYP2C9 (for warfarin metabolism), which contribute up to 40% of individual patient variations in response to using warfarin.
- The WARFARIN Study will assess the extent to which serious adverse events – hemorrhage and clotting – can be avoided when warfarin dosing is guided by genetic testing for these two genes, as compared to warfarin dosing calculated without these pharmacogenetic data.
- The study will enroll more than 7,000 patients at up to 50 study sites nationwide; patients' rates of warfarin-related adverse events will be studied at 30, 60 and 90 days from initial warfarin dosing.
• Trial registration and study sites can be found at www.warfarinstudy.org.
(Source: Iverson Genetic Diagnostics, Inc.)
About Sarasota Memorial
Sarasota Memorial Health Care System is a regional referral center offering Southwest Florida’s greatest breadth and depth of inpatient, outpatient and extended care services, with more than 800,000 patient visits a year. Sarasota Memorial’s 806-bed acute care hospital has been recognized repeatedly as one of the nation’s largest, safest and best, with superior patient outcomes and a complete continuum of outpatient services– from urgent care clinics and physician groups, laboratory and diagnostic imaging centers, to home health and skilled nursing & rehabilitation. Sarasota Memorial is the only hospital in the Suncoast region (Sarasota, Manatee, Charlotte and DeSoto counties) ever to rank in U.S. News & World Report’s “Best Hospitals” and HealthGrades “America’s 50 Best Hospitals” lists.
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