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DAVID A. MACDOUGALL, M.B.A., is Account Director; ANTHONY L. FELIU, PH.D., is Analytic Developer; and STEPHEN J. BOCCUZZI, PH.D., M.B.A., is Vice-President and Chief Scientific Officer, PharMetrics, Watertown, MA. JAY LIN, PH.D., M.B.A., is Health Outcomes Manager, sanofi-aventis U.S., Inc., Bridgewater, NJ.

Address correspondence to Mr. MacDougall at PharMetrics, a unit of IMS, 311 Arsenal Street, Watertown, MA 02472 (dmacdougall{at}pharmetrics.com).

Purpose. Deep-vein thrombosis (DVT) and pulmonary embolism (PE) are associated with major morbidity and mortality, with their burden often extending to longer-term complications such as event recurrence and post-thrombotic syndrome (PTS). Few data exist on the overall economic burden of DVT and PE and their sequelae. A retrospective observational cohort study was conducted to determine the direct medical costs of a DVT or PE patient across the entire continuum of care. Summary. Administrative claims data for patients with a DVT or PE diagnosis (ICD-9-CM code) and patients with possible evidence of PTS between January 1, 1997, and March 31, 2004, were extracted from the PharMetrics Patient-Centric Database, which comprises fully adjudicated medical and pharmaceutical claims for U.S. health care-plan enrollees. Resource utilization and annualized direct medical costs of care for patients with DVT and/or PE were calculated and compared with matched controls. A total of 26,958 patients met the study inclusion criteria. Of the 17,634 patients evaluable for the PTS cohort, 663 (3.8%) patients experienced PTS. Patients with DVT, PE, or DVT and PE had higher annualized direct medical costs before the index (initial) DVT and/or PE event (median: $7227, $6381, and $6771, respectively) than controls (median: $1045). During and after the DVT/PE event, annualized median costs rose to $17,512, $18,901, and $25,554, respectively, compared with $680 in the control group. Annualized median total costs for the PTS group were $20,569 compared with $15,843 in matched controls with DVT and/or PE and no PTS. Conclusion. These data suggest that the initial acute DVT or PE event is associated with high total health care costs and that these costs are further increased by subsequent events such as recurrent DVT or PE and PTS. Early detection and appropriate treatment of this high-risk population have the potential for both clinical and economic benefits. Index terms: Costs; Economics; Mortality; Pulmonary embolism; Venous thrombosis