Medco Research Institute Study Shows Some Patients Discontinue New Anticoagulant Drug Early, Which May Increase Stroke Risk

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The study was presented at the American Heart Association Scientific Sessions 2011 in Orlando FL.

Authors: Stanek, Barnabie C. Agatep, Vivian Herrera, Gosia Hawk, Bruce J. Schrader, Pittman, Felix W. Frueh, and Scott L. Charland (senior investigator)

Patients using Pradaxa (dabigatran), a new blood thinner aimed at preventing stroke and blood clots, failed to remain on the treatment 17 percent of the time after the first four months, according to a study presented at the American Heart Association’s Scientific Sessions.

The research conducted by Medco Research Institute™, a subsidiary of Medco Health Solutions, Inc. (NYSE:MHS), is the first real-world study to examine dabigatran’s use since its introduction last year. Dabigatran is an alternative to the popular blood-thinner warfarin, a drug dating to the 1950s and sold under the brand names Coumadin® and Jantoven®. Warfarin can be difficult to dose properly and patients need to be monitored closely to prevent bleeds or blood clots. The study showed that warfarin therapy was prescribed in 71 percent of patients during the prior 6 months to starting dabigatran treatment, suggesting that prescribers are adopting dabigatran as an alternative to warfarin.

“Dabigatran is indicated to prevent serious health conditions such as stroke and systemic embolism in patients with nonvalvular atrial fibrillation, so we wanted to examine how people are using the medication, and more importantly, if patients are staying on this vital therapy,” said Dr. Eric Stanek, vice president of research at Medco. “We are seeing a sizable proportion of patients drop off treatment in a fairly short time. This is a twice-daily drug and stroke prevention outcomes may be particularly sensitive to how consistently patients take it, pointing to a need and opportunity to provide dedicated and proactive patient support.”

“We have begun to engage patients with gaps in their dabigatran therapy, and our specialist pharmacists help them get back to taking it as prescribed or notify their doctors to consider an appropriate alternative” said Dr. Donald Pittman, national practice leader of the Medco Cardiovascular Therapeutic Resource Center®. “Our data show the importance of actively monitoring the course of therapy in patients taking dabigatran. No matter how effective it can be at preventing a stroke, it won’t work if patients don’t take it, which means doctors and pharmacists need to regularly monitor persistence and discuss adherence to therapy with dabigatran.”

Researchers also found higher associated short-term rates of hospitalization for stroke and systemic embolism and bleeding than was reported in a previous clinical trial with dabigatran in September 2009; the Randomized Evaluation of Long-Term Anticoagulation Therapy study (RE-LY) was a head-to-head study of the drug versus warfarin. The RE-LY study found patients who received dabigatran 150 mg twice a day had a similar bleeding risk, but a lower incidence of stroke and blood clots compared to warfarin. Dabigatran is usually prescribed at 150 mg twice a day; however, some patients with reduced kidney function should receive 75 mg twice a day.

“It’s not unusual to see a difference in event rates between clinical trials and the ‘real-world’ experience when it comes to newly-marketed prescription drugs,” Stanek said. “This further highlights the need for continuous surveillance of anticoagulant drug effectiveness and safety, as well as the opportunity to conduct longer-term comparative outcome studies on warfarin and alternative agents such as dabigatran and rivaroxaban.” Stanek added “It will be particularly interesting to further explore the role of warfarin pharmagenomics in such a comparison, and we have plans underway to do just that.”

Study Details
Medco examined de-identified prescription claims between Nov. 1, 2010 and Dec. 31, 2010 for 1,143 patients prescribed dabigatran for up to four months of follow-up. Medical diagnoses were determined by de-identified medical claims. Demographic and clinical characteristics of patients, prescriber specialty, 4-month persistence to dabigatran therapy, and hospitalization for stroke or systemic embolism and bleeding were assessed. Persistence to the medication at 120 days was calculated allowing a 45-day supply gap. The average patient was 73 years old, and was using nine chronic medications. Medical history over the 12 months prior to initiating dabigatran included: stroke (10 percent); venous thromboembolism (5 percent); pulmonary embolism (5 percent); valve replacement (2 percent). About 19 percent had a prior history of bleeding, and 13 percent did not have a medical claims history of atrial fibrillation. Patients received their dabigatran prescriptions mainly through retail pharmacies. Overall, cardiologists were the highest prescribers (62 percent), followed-by primary care physicians (23 percent).

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 the Medco Research Institute’s peer-reviewed research can be found at www.medcoresearch.com.

About Medco
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.

With more than 20,000 employees worldwide dedicated to improving patient health and reducing costs for a wide range of public and private sector clients, and 2010 revenues of nearly $66 billion, Medco ranks 34th on the 2011 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.

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