Largest Warfarin Patient Self-Testing Study Results Establish New Standard of Care

WALTHAM, Mass.--(BUSINESS WIRE)--

Today, at the 2012 American College of Cardiology Summit, Alere Inc. ALR was pleased to announce the results from the world's largest study of warfarin (Coumadin®) patient self-testers, performed by anticoagulation expert, Jack Ansell, MD, which showed that self-testing led to excellent therapy control. In the United States, among the general adult population, stroke is the leading cause of disability and the third leading cause of death. Since the late 1980s, warfarin has been the drug of choice for preventing ischemic strokes caused by blood clots, and more than 3 million patients currently take the blood thinner. While warfarin is one of the most effective medications prescribed today, the drug can have dangerous side effects if managed improperly—the most common of which is bleeding—and these side effects have proven to be barriers to its more widespread use.

Warfarin, according to Dr. Ansell, is underused as well as poorly managed on a global basis because of the complexities associated with managing the drug and fear of adverse events. In fact, difficulty managing warfarin and fear of bleeding risk have accelerated the development of new classes of anticoagulants that do not require routine monitoring.

With that said, the STABLE study evaluated more than 29,500 U.S.-based, real-world patient self-testers (PST) for more than two years and found that PST, as part of a comprehensive support service, delivered and sustained high quality control of warfarin. Time in therapeutic range was 69.7% for all self-testers and 74% for those who tested weekly.

Additionally, when compared to historical data from other trials, weekly patient self-testers performed significantly better than other classes of self-testers. Not only was time in target range for these individuals higher, but they also benefited from major reductions in the number of critical-value INR results (INRs < 1.5, > 5.0), which can triple the risk of a major bleeding event or stroke (CMS, NEJM, Hylek). The STABLE study demonstrates that, by applying the diabetic-management model (more frequent, self-testing) to warfarin therapy, one can optimize safety and efficacy. Moreover, the percent time in range observed in this study surpassed that of other, well-designed clinical trials, including the 2,922-patient, VA Cooperative THINRS trial (TTR = 66.2%).

“The STABLE study dispels many myths surrounding safe warfarin treatment, particularly those related to the drug's use in the elderly population and that population's ability to successfully self-test,” said Ansell. Results come just one month after the American College of Chest Physicians (ACCP), which establishes treatment practices and standards of care, released clinical evidence in support of patient self-testing over usual outpatient INR monitoring (ACCP, 2012, p.163S).

Warfarin remains an affordable, effective and safe choice for many patients at risk for ischemic stroke. While new agents have been approved and others remain in development, they have been shown to deliver comparable results to sub-optimal warfarin control in terms of safety and efficacy.

As STABLE demonstrates, however, PST, particularly weekly testing, can sustain high TTR for extended periods of time. One explanation for this trend is that clinicians who manage weekly self-testers receive consistent feedback in the form of INR test results, which in turn enables them to assess patients' adherence to therapy and intervene when appropriate.

STABLE affirms that considerable adherence to real-world weekly patient self-testing is attainable and can lead to high-quality anticoagulation control not seen before in well-controlled clinical trials. These conclusions should positively influence the appropriate utilization of warfarin and benefit health plans challenged with balancing quality care and drug cost containment.

About Alere Anticoagulation Solutions

Alere is the leader in anticoagulation monitoring and management services. We've helped over 10,000 clinicians track 450,000 patients and 30 million INR tests by providing the critical tools needed to safely manage anticoagulation patients. We improve clinical, operational and economic outcomes for physicians, and offer more freedom and better quality of life for patients. Our clinically proven, connected offerings consist of a finger-stick INR monitor, home INR monitoring service, and disease management software. Together these components provide increased INR visibility and decision-making support designed to improve patient safety across the continuum of care. For further information about Alere's anticoagulation services please call: 866-262-4669.

About Alere

By developing new capabilities in near-patient diagnosis, monitoring and health management, Alere ALR enables individuals to take charge of improving their health and quality of life at home. Alere's global leading products and services, as well as its new product development efforts, focus on cardiology, infectious disease, toxicology, diabetes, oncology and women's health. Alere is headquartered in Waltham, Massachusetts. For more information regarding Alere please visit www.alere.com.