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Media Release

Basel, 18 April 2005

Coagulation Self-Management with Roche’s CoaguChek S System can save lives

Study shows that CoaguChek S diagnostics system substantially reduces bleeding complications and mortality rate after mechanical heart valve replacement

Patient self management with the CoaguChek S system from Roche Diagnostics reduces the risk of major complications and minor hemorrhages by up 70% and the event of mortality by up to 60%. This was demonstrated by a new study comparing self-management of oral anticoagulant therapy with clinic management

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“CoaguChek S system can help to give patients independence and – even more significant – safety and peace of mind, in short, real improvement quality of life” said Heino von Prondzynski, CEO Division Roche Diagnostics and Member of Roche’s Corporate Executive Committee. “Additionally, patient self management is cost-effective and demonstrates that modern diagnostics may reduce the cost of the healthcare system. The authors of the ACOA study estimate that at least 50% of patients on anticoagulant therapy could safely use patient self-management to monitor their treatment.”

Oral anticoagulation is well established in many fields of medicine including secondary prevention of cardiovascular thromboembolic events. It is important to monitor the therapeutic effect and to keep possible risks at the lowest possible level. Scheduling the dose of anticoagulants in an optimal way can reduce the incidence of bleeding complications without increasing thromboembolic events. Self testing with the CoaguChek S system gives patients information about their level of anticoagulation and allows them to adjust the doses of medication if necessary.

About the ACOA study
ACOA was a randomized, controlled trial involving 737 patients with indications for anticoagulant treatment. It compared a conventional management group for oral anticoagulant therapy with a self-management group. The study demonstrates a risk-reduction of nearly 70% for the self-management group concerning major complications. The authors of the study suggest that the ideal way to provide access to self-management for as many patients as possible would be patient self-management supported by a specialized clinic. The major complication rate was 7.3% in the conventional management group and 2.2% in the self-management group, which corresponds to a risk reduction of 69.8%. Minor hemorrhages also occurred less frequently (36.4% vs. 14.9%) and there was a mortality reduction of 60% (4.1% vs. 1.6%).

About CoaguChek S
The portable CoaguChek S System quantitatively determines the thromboplastin time on the spot within one minute using capillary blood from the fingertip or untreated venous whole blood. This means fast information for patients about their required doses of anticoagulant medication. The immediate availability of results significantly improves the workflow of healthcare professionals. The simplicity of operation makes it easy and convenient for patients to monitor and even manage their therapy. Sales of Roche Diagnostic’s CoaguChek S System in 2004 reached more than 150 million Swiss francs, continuing the double digit annual growth shown over the past 3 years. For more information: www.coaguchek.com.

The CoaguChek System is not approved for self testing or self-management in the United States.

About Roche
Headquartered in Basel, Switzerland, Roche is one of the world’s leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As a supplier of innovative products and services for the early detection, prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people’s health and quality of life. Roche is a world leader in diagnostics, the leading supplier of medicines for cancer and transplantation and a market leader in virology. In 2004 sales by the Pharmaceuticals Division totalled 21.7 billion Swiss francs, while the Diagnostics Division posted sales of 7.8 billion Swiss francs. Roche employs roughly 65,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. Additional information about the Roche Group is available on the Internet (www.roche.com).


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1 (Comparing Self-Management of Oral Anticoagulant Therapy with Clinic Management; Annals of Internal Medicine. 2005;142:1-10; ACOA study).


Additional information:
- Roche Diagnostics: www.roche-diagnostics.com