Study to determine whether effectiveness of Plavix is similar to Effient based on patient's genetic makeupGenetics for Generics(TM) - with Plavix going generic in 2011 a financial savings may be found with widely used blood thinner
Oct. 20, 2009 (PR Newswire) --
FRANKLIN LAKES, N.J., Oct. 20 /PRNewswire-FirstCall/ -- Medco Health Solutions, Inc. (NYSE: MHS) today announced it will conduct a head-to-head study of Plavix® (clopidogrel) and Effient® (prasugrel) that measures how the effectiveness of these drugs in heart patients is impacted by their genetic make-up. The study will examine whether the 70 to 75 percent of patients who are "extensive metabolizers" of clopidogrel - because they were born with a normally functioning version of the CYP2C19 gene - have comparable outcomes to those patients taking prasugrel, a newer, higher cost drug with metabolism less dependent on genetic variations.
Prasugrel has shown greater efficacy but higher bleeding risk than clopidogrel in head-to-head clinical trials, but to date none of the studies limited the patient population to those who extensively metabolize clopidogrel, which could substantially impact the results. The study could have important patient safety ramifications and significant cost implications for health plans that pay for these drugs. Clopidogrel, the third largest selling drug in the United States with $4.9 billion in 2008 sales, could face generic competition when its patent expires in late 2011, creating additional savings opportunities.
"These drugs are an important part of therapy for people with recent coronary events to prevent further cardiovascular problems," said Dr. Robert Epstein, Medco's chief medical officer. "This study could have a huge bearing on patient safety and the costs to treat this condition. Plavix is going generic in 2011 and if found to be equally effective as Effient for patients who have a normally functioning version of the CYP2C19 gene, the study provides the evidence that would allow these patients to opt for a lower cost treatment. This study is a great example of Medco's new Genetics for Generics strategy, optimizing clinical outcomes of generic drugs while lowering overall health care costs."
"Studies like this are necessary to show how innovation can derive greater value from what we spend on health care," said Michael O. Leavitt, former U.S. Secretary of Health and Human Services. "A simple test can identify a drug's ability to work for a particular patient or point them to another one that could provide a better outcome. Personalized medicine is the new frontier in making medication safer and more effective.