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| |  FDA Approves CoaguChek System For Patients on Anticoagulants INDIANAPOLIS, May 1, 1997 -- The U.S. Food and Drug Administration (FDA) has approved for a new device that allows people taking anticoagulants -- more commonly known as "blood thinners" -- to monitor themselves their response to therapy at home. This device, the CoaguChek(TM) System, was developed by Boehringer Mannheim Corporation's (BMC), which also provides patients and physicians with a comprehensive quality management system for optimum management of their health. The support package includes in-depth standardized training, technical support, and the added benefits of support via alliances with St. Jude Medical and DuPont Pharma -- two leading companies involved in anticoagulation therapy. Currently, more than 1.5 million people take anticoagulants, which are effective in preventing strokes and congestive heart failure in people with atrial fibrillation (irregular heartbeat) or those who have had surgery such as mechanical heart valve replacement. Numerous studies indicate that those individuals participating in self-testing of anticoagulant therapy remain within the correct therapeutic range more often than patients who follow traditional methods of monitoring. BMC has more than 10 years of experience in the research and manufacture of coagulation monitors and was the first company worldwide to offer prothrombin time self-testing, with more than 14,000 patients using the CoaguChek System in Germany. According to Jack Ansell, M.D., professor of Medicine at Boston University Medical Center, "Patient self-testing provides several clinical advantages. It invests the patients in their own care; it empowers them to be interested in their care and to be as compliant as possible. Self-testing allows greater frequency of testing. And, that results in improved control and better patient management." Clinical Results According to a clinical study by H.I. Bussey et al., published in Journal of Thrombosis and Thrombolysis, patients showing a 30-percent increase in their time within therapeutic range show as much as a 76-percent decrease in major adverse event rates. Additionally, a study by Dr. Ansell et al. That was published in Archives of Internal Medicine showed that 88.6 percent of patients who self-test were within range, versus 68 percent of control patients. This study also concluded that patients who self-test achieve superior anticoagulation control than do those patients who receive routine medical care. Finally, a study conducted by D.R. Anderson et al. And published in Archives of Internal Medicine showed that 38 of 40 patients questioned six months after initiation of self-testing said that self-testing causes less discomfort, less anxiety and less inconvenience than traditional laboratory testing. The greatest benefit of self-testing is that it allows you to pick up trends in your dosage levels promptly," says Coumadin user Joseph Devlin. "For example, a few weeks ago, my INR reading was unusually high. I was able to spot this immediately, talk with my doctor and adjust my dosages. That's the type of participation I want to have in my health, and self-testing allows me to be a part of it. The system is easy to administer; and I test as necessary in my own home. I manage my therapy with my doctor," he adds. More Than a Product -- A Total Quality Management System In order to support those physicians and patients participating in self-testing, BMC offers numerous additional services to users, including comprehensive training to ensure optimum health management with the CoaguChek System. In order to receive the CoaguChek System, patients must complete a standardized training program taught by a healthcare professional. To prepare the healthcare professionals, BMC has instituted a staff of Master Faculty trainers, comprised of registered nurses and clinical laboratory professionals, many who have trained patients on anticoagulation therapy in the past. The Master Faculty Trainers provide a standardized training program that is adapted from those used successfully in Europe for the past several years. BMC also offers users a toll-free telephone support line to address technical issues and reimbursement questions. In addition, BMC has developed a package of training materials designed to help patients and physicians understand and incorporate self-testing into their therapy regimen. The materials -- called the "Manage & Maintain" program -- include booklets targeted to physicians that focus on improving patient outcomes and establishing accurate results with the CoaguChek System for self-testing. An in-depth fact sheet describing the specific features of the CoaguChek System gives step-by-step instructions on use of the device, as well as operating requirements. Also included in the "Manage & Maintain" program is a booklet that physicians can provide to those patients who begin self-testing. It includes information to help patients understand the importance of maintaining their prothrombin time, the benefits of anticoagulation therapy and self-testing, and the role patients play in managing their own health. BMC has also forged alliances with other leading companies in the anticoagulation therapy field. BMC and St. Jude Medical -- world-leading manufacturer of mechanical heart valves -- are working to provide solutions for the more than 450,000 heart valve patients in the United States who are candidates for self-testing. This alliance also stands to support future heart valve patients by providing physicians with a safe and effective solution to managing anticoagulation therapy. A second alliance is with DuPont Pharma -- manufacturer of Coumadin(R), the trade name for the most common oral anticoagulant, warfarin. This educational alliance pools the resources from both companies to better educate patients and physicians on the benefits of Coumadin use and the different PT monitoring options available to patients taking anticoagulants. BMC has extensive experience in the coagulation markets in the United States and in Germany. The company offers a line of monitors for use by laboratories, anticoagulation clinics, physicians' offices and now by patients for self-testing. Headquartered in Indianapolis, Boehringer Mannheim is a diversified international healthcare company.
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