Healthcare Industry News: sanofi-aventis
News Release - November 16, 2010
GRAVITAS Trial Shows That a Uniform Treatment Strategy of Doubling the Standard Dose of Plavix Does Not Improve Outcomes Post-PCIHigher Cardiac Event Rates Seen in Patients with Higher Residual Platelet Reactivity, as Measured by the VerifyNow P2Y12 Test
SAN DIEGO, Nov. 16, 2010 -- (Healthcare Sales & Marketing Network) -- Accumetrics, Inc., developer and marketer of the VerifyNow® System, today announced that the GRAVITAS (Gauging Responsiveness With A VerifyNow Assay-Impact On Thrombosis And Safety) Trial found that in patients with high residual platelet reactivity, doubling the maintenance dose of clopidogrel did not reduce the risk of further ischemic events after percutaneous coronary intervention (PCI). The study also reported that patients with high residual platelet reactivity, as measured by the VerifyNow P2Y12 test, demonstrated almost twice the risk of ischemic events compared to patients without high residual platelet reactivity. The VerifyNow P2Y12 Test is used to measure the antiplatelet effect of medications such as clopidogrel or prasugrel (Plavix® and Effient®) that reduce platelet reactivity by blocking the platelet P2Y12 receptor.
Matthew J. Price, MD, of the Scripps Translational Science Institute and Scripps Clinic in La Jolla, CA, and Principal Investigator of the GRAVITAS trial, presented the results during the American Heart Association Scientific Sessions Late-Breaking Clinical Trials in Chicago. "The GRAVITAS findings do not support a uniform treatment strategy of high dose clopidogrel in patients with high residual platelet reactivity based upon a single platelet function test after stent implantation. This is important as currently many physicians utilize a strategy of doubling the dose of clopidogrel the morning after the stent procedure," commented Dr. Price. "Alternative therapies or testing a patient multiple times to treat to a specific target of reactivity deserve consideration."
"The GRAVITAS trial provides further evidence of the association between high residual platelet reactivity, sometimes referred to as non-responsiveness, and the occurrence of cardiovascular events. The trial demonstrated a strong trend towards greater risk of ischemic events in non-responders, which is consistent with prior reports," commented Jeffrey R. Dahlen, PhD, Vice President of Clinical and Regulatory Affairs for Accumetrics. "As we further analyze the data, we expect to release additional information that continues to support the value of platelet function testing."
"GRAVITAS continues to position Accumetrics as a diagnostic leader that invests in furthering clinical understanding of individualized treatment for cardiovascular patients," said Timothy I. Still, President and CEO of Accumetrics. "This trial highlights the importance of continually assessing response to antiplatelet therapy as physicians consider various treatment strategies."
The VerifyNow System is the first rapid and easy-to-use point-of-care system for measuring platelet reactivity to multiple antiplatelet agents. The System is widely used in various clinical settings where antiplatelet medications are prescribed to reduce the occurrence of future thrombotic events such as heart attack and stroke. Clopidogrel is an oral antiplatelet agent sold under the brand name Plavix.
About the GRAVITAS Study
The concept of variability in response to antiplatelet therapy has been well established. Also being demonstrated with increased frequency is that high residual platelet reactivity is associated with poor patient outcomes. Accumetrics recognized the need for a study specifically designed to explore possible treatment strategies for those patients who are poor responders to antiplatelet therapy. As a result, the GRAVITAS study is the first multi-center, placebo-controlled study to determine whether high maintenance dose of clopidogrel therapy based on the results of the company's VerifyNow P2Y12 Test reduces ischemic events post- PCI. The trial was coordinated by Scripps Advanced Clinical Trials.
Accumetrics is committed to advancing medical understanding of platelet function and enhancing quality of care for patients receiving antiplatelet therapies by providing industry- leading and widely accessible diagnostic tests for rapid platelet function assessment.
Accumetrics' VerifyNow System is the first rapid and easy-to-use platform to help physicians determine an individual's response to multiple antiplatelet agents. Addressing every major antiplatelet drug, including FDA-cleared products for aspirin, P2Y12 inhibitors (e.g. prasugrel (Effient®) and clopidogrel (Plavix®)), and GP IIb/IIIa inhibitors (e.g. ReoPro® and Integrilin®), the VerifyNow System provides valuable information to help physicians make informed treatment decisions. For more information about the Company and its products, visit www.accumetrics.com.
The Accumetrics logo and VerifyNow are registered trademarks of Accumetrics, Inc. ReoPro is a registered trademark of Centocor, Inc. Integrilin is a registered trademark of Millennium Pharmaceuticals. Plavix is a registered trademark of sanofi-aventis. Effient is a registered trademark of Eli Lilly and Company.
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