Oral anticoagulation: challenges in the case-management setting

By understanding barriers, providing education, and advocating appropriate treatment, case managers play an essential role in the prevention and treatment of thromboembolic disorders. Yet, thromboembolic events such as stroke and deep-vein thrombosis still result in substantial morbidity and mortality despite the availability of effective prophylactic anticoagulation therapy. Although oral warfarin, because of its established efficacy, remains the mainstay in the prevention and treatment of thromboembolic disorders associated with atrial fibrillation, a common antecedent, it is fraught with enduring impediments that hinder effectiveness, safety, and use. With a narrow therapeutic widow, optimal treatment relies on maintaining a tight international normalized ratio (INR) range, usually between 2.0 and 3.0. Lacking intensive anticoagulation clinic monitoring, patients are often outside the therapeutic range, compromising efficacy or safety. Furthermore, the need for frequent and demanding INR monitoring, a slow onset of action, and an elevated risk for drug-drug and food-drug interactions conspire to undermine the use of warfarin, especially in high-risk groups, such as the elderly. Unquestionably, well-tolerated, convenient, and effective alternatives to oral warfarin are needed to improve the management of patients in need of anticoagulation therapy. Several new oral anticoagulants are in development, but only one, ximelagatran, has completed Phase-III development and awaits Food and Drug Administration (FDA) approval. An oral direct thrombin inhibitor, ximelagatran, appears to offer a profile quite different from warfarin: a wide therapeutic window that obviates routine drug-level monitoring and twice-daily oral administration with minimal drug interactions; however, transient liver enzyme elevations remain an unresolved issue. As case managers typically work with those who present with clinical or psychosocial challenges, or both, this treatment approach may provide an alternative that would enhance patient outcomes.