Medco announced today that it is launching a large head-to-head prospective, observational study comparing clopidogrel (Plavix) and prasugrel (Effient) in more than 14,000 patients. The study, GeCCO (Genotype Guided Comparison of Clopidogrel and Prasugrel Outcomes Study), is designed to assess whether clopidogrel given to patients who are CYP2C19 extensive metabolizers is noninferior to prasugrel on the composite primary endpoint of CV death, nonfatal MI, or nonfatal stroke.
Clopidogrel patients, but not prasugrel patients, will undergo genotype testing to determine if they are extensive metabolizers of CYP2C19. In recent years cardiovascular researchers have persistently raised concerns that a minority of clopidogrel patients may not receive the full antiplatelet benefit of clopidogrel because they are unable to fully metabolize the drug to its active. A corollary of this observation is that the majority of patients may have an antiplatelet effect equal to that of prasugrel.
“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, in a company press release. “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.”
The principal investigator of GeCCO is Eric J. Stanek, Pharm. D., a Medco employee. A Medco spokesperson told CardioBrief that the company is conducting this study by itself and does not have an academic partner.
Here is the Medco press release:
Medco Launches Plavix(R), Effient(R) Comparative Effectiveness Study Examining Role of Genetics
Study to determine whether effectiveness of Plavix is similar to Effient based on patient’s genetic makeup
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. What we learn from this study, and others like it, will save lives and money.”
The Genotype-Guided Comparison of Clopidogrel and Prasugrel Outcomes Study (GeCCO) will enroll more than 14,000 acute coronary syndrome patients who have been newly prescribed these drugs. The study will compare effectiveness of the two drugs by measuring the rate of cardiovascular deaths, nonfatal heart attacks and nonfatal strokes over a six-month period. Patient enrollment is starting later this fall and is scheduled to end in mid-2011 with results to be presented by early 2012. Patients enrolled in the study using clopidogrel will be required to provide a saliva sample to determine if their genetic make-up allows them to metabolize the drug effectively. Patients using prasugrel will not need to use a gene test since the drug is metabolized by a different pathway that is not affected by genetic variations. The study is registered on http://www.clinicaltrials.gov (ID#: NCT00995514).
About 25 percent of people worldwide are born with a version of the CYP2C19 gene that produces a cytochrome P450 P450 “>2C19 enzyme that is not fully functional. This cytochrome P450 2C19 enzyme metabolizes many prescription drugs, including clopidogrel. When Plavix is broken down in the body, it produces an active form of the drug that prevents clotting by making blood platelets less likely to stick together. However, people born with a version of the gene that cannot metabolize the medication efficiently may be less responsive to it, and are more likely at risk for a major cardiovascular event including heart attack or stroke.
The label for Plavix was revised in May of this year to provide information to prescribers about how genes like CYP2C19 can affect the action of the drug. The study will also collect new information on physician action taken and clinical outcomes in this 25 to 30 percent of patients who do not extensively metabolize clopidogrel because of their CYP2C19 genotype.
For more information about Medco research efforts, please visit http://www.medcoresearch.com.
Medco Health Solutions, Inc. (NYSE: MHS) is pioneering the world’s most advanced pharmacy® and its clinical research and innovations are part of Medco making medicine smarter(TM) for more than 60 million members.
With more than 20,000 employees dedicated to improving patient health and reducing costs for a wide range of public and private sector clients, and 2008 revenue exceeding $51 billion, Medco ranks 45th on the Fortune 500 list and is named among the world’s most innovative, most admired and most trustworthy companies.
For more information, go to http://www.medcohealth.com.
This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties that may cause results to differ materially from those set forth in the statements. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the risks and uncertainties that affect our business, particularly those mentioned in the Risk Factors section of the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission.
SOURCE Medco Health Solutions, Inc.