Study is the first head-to-head trial of heartburn drug's effect on anti-platelet therapy in patients with coronary artery disease
PARIS, July 27 /PRNewswire-FirstCall/ -- Medco Research Institute™, LLC, a wholly owned subsidiary of Medco Health Solutions, Inc. (NYSE: MHS), is sponsoring a study to determine the optimal antiplatelet treatment for patients who are also using a proton pump inhibitor (PPI), a commonly prescribed category of heartburn medications. The study will examine the impact that the PPI, Prevacid® (lansoprazole), has on the effect of two different anti-platelet agents, Effient (prasugrel) and a double-dose of Plavix (clopidogrel), the third top selling drug in the U.S. with $5.6 billion in sales last year. The Paris-based study is the first head-to-head comparison of concurrent use of PPIs and these two antiplatelet medications in patients with coronary artery disease.
PPIs, which are often prescribed with anti-platelet agents to prevent gastrointestinal bleeding, have been shown to blunt the clinical benefit of clopidogrel and raise the risk of a major adverse cardiovascular event such as a stroke or heart attack by 50 percent in patients using both drugs together. The study aims to determine if lansoprazole would be less likely to impair the efficacy of clopidogrel taken at a double dose (150 mg) per day and contrast that result with prasugrel, a newer, costlier drug found to be more effective but with a greater bleeding risk than clopidogrel. Clopidogrel and prasugrel are currently prescribed to prevent cardiovascular death, myocardial infarction and stroke in patients who have a recent heart attack or acute coronary syndrome with or without a stent.
France's Ascopharm Groupe Novasco will manage the 104-patient study for the Medco Research Institute being conducted by researchers at Hospital Pitie' Salpetriere', which houses one of the leading cardiovascular research centers in Europe. The patients will be divided into two groups, one receiving prasugrel and the other receiving 150 mg per day of clopidogrel. Within each group, patients will then receive either lansoprazole or placebo treatment. Researchers, led by Dr. Jean-Sebastien Hulot, will measure the anti-platelet effect of the medications in each group at the start and two weeks after patients have been receiving the PPI. Additionally, each patient in the study will take a genetic test to determine whether they can metabolize clopidogrel into its active form and measure the impact the patients' genetic profile has on these medications. Genetic variations can hinder a person's ability to metabolize certain medications and therefore can inhibit the efficacy of a drug like clopidogrel, similar to a PPIs effect. The study is expected to be finished within a year.
"What we already know is that the benefits of Plavix can be blunted either by genetics or the use of second drugs like a proton pump inhibitor," said Dr. Robert S. Epstein, Medco's chief medical officer and president of the Medco Research Institute. "What we hope to learn from this study is whether you can avoid this problem through double dosing Plavix or whether you need to move on to newer drugs like Effient. This is important from both a clinical and economic standpoint as health systems around the world are struggling with the issues of cost and quality of care."
Medco's earlier research on clopidogrel -- the Clopidogrel Medco Outcomes Study (CMOS) -- found that using any one of several different PPIs in conjunction with clodpidogrel increases the risk of hospitalization for a cardiovascular event by 51 percent over a one-year time period. The CMOS study was recently published in the journal Pharmacotherapy, and full study results can be found at www.pharmacotherapy.org.
"We're looking to build a solid foundation for our knowledge about how anti-platelet drugs work and what can be done to make them more effective," said Dr. Hulot. "Evidence has shown that PPIs can interfere with anti-platelet agents and increase the cardiovascular risks patients face when trying to counter the risk for gastric bleeding. For a long time, PPIs were prescribed with Plavix. It took research from Medco and others to show the risks associated with this practice."
This study could lay the groundwork for additional collaborative research efforts in the field of personalized medicine, an area of investigation in which Medco has been a leading force.
Medco Research Institute recently launched a head-to-head study of clopidogrel and 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. Results of the study, which is part of Medco's "Genetics for Generics" approach to finding opportunities to use lower cost drugs, are expected in 2012 (NCT00995514). Plavix is expected to face competition in 2012 from lower-cost, generic versions of the drug when its patents expire.
About 25 percent of people worldwide are born with a version of the CYP2C19 gene that produces a cytochrome P450 2C19 enzyme that is not fully functional. This cytochrome P450 2C19 enzyme metabolizes many 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 United States Food and Drug Administration revised the label for Plavix in May 2009, and again in March 2010, to include a stronger recommendation for genetic testing. In March, the European Medicines Agency said it is discouraging patients from using Plavix with omeprazole and esomeprazole, both of which are PPIs.
About Medco Research Institute
Medco Research Institute™ is an evidence-based research organization focused solely on novel research, analytics and new discoveries that close the gap between scientific discovery and medical practice for improved patient outcomes and lower overall healthcare costs. More information about Medco Research Institute's peer-reviewed research can be found at www.medcoresearchinstitute.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™ for approximately 65 million members.
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