ORLANDO, Fla., Nov. 14, 2011 /PRNewswire/ -- 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.
(Logo: http://photos.prnewswire.com/prnh/20100609/MEDCOLOGO)
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).
The study was presented at the American Heart Association
Scientific Sessions 2011 in Orlando,
FL. Stanek, Barnabie C.
Agatep, Vivian Herrera,
Gosia Hawk, Bruce J. Schrader, Pittman, Felix W. Frueh, and Scott L. Charland (senior investigator) authored
the study.
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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SOURCE Medco Health Solutions, Inc.