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New study finds no benefit to selecting dose of blood thinner based on patients' genetic makeup
Date:11/19/2013

ectiveness. In 2007 and 2010, the FDA worked with the makers of warfarin drug products to modify the product label to indicate that a patient's genetic makeup may affect how he or she responds to the drug and that genetic information might be useful in determining the optimal starting dose.

To find out whether these genes could help clinicians prescribe an optimal dose, the Clarification of Optimal Anticoagulation through Genetics (COAG) trial consisting of 18 clinical sites across the country and funded by the National Heart, Lung and Blood Institute (NHLBI) tested two approaches for determining the best initial dose of warfarin in patients who were expected to need therapy for at least one month or longer by clinical information alone or by clinical information plus specific genetic information. The four-year study included 1,015 patients randomly assigned to one of two groups during the first five days of initiating warfarin therapy.

For the patients in the clinical-based dosing group, the initial warfarin dose was determined using step-by-step procedures based only on information about clinical factors, such as age, sex, weight, ethnicity, and the use of other medications. In the gene-based dosing group, the initial dose was determined using this same clinical information as well as information about the patient's genetic makeup, including analyzing the participants' DNA for the CYP2C9 and VKORC1 genes. Patients and their providers were blinded to the dose of warfarin for the first month of therapy.

The researchers found that there was no difference among the two groups in mean percentage of time in therapeutic range (PTTR) for the medication (45.2 percent in the pharmacogenetic-dosing group versus 45.4 percent in the clinical-guided dosing group) at four-weeks. There was, however, a statistically significant difference by race. Among African Americans, the mean PTTR for the pharmacogenetic-guided dosing group was less than that
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Contact: Jessica Mikulski
jessica.mikulski@uphs.upenn.edu
215-796-4829
University of Pennsylvania School of Medicine
Source:Eurekalert

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