[Prophylaxis of deep vein thrombosis with enoxaparin 40 mg in outpatients compared to hospitalized medically ill patients].

PURPOSE: The efficacy and safety of enoxaparin 40 mg in the prevention of thromboembolic events have been examined in immobilized nonsurgical hospitalized patients as well as in the outpatient setting. PATIENTS AND METHODS: 800 outpatients from 275 sites and 381 patients from 80 hospitals with an acute medical illness leading to a reduced physical activity were enrolled in a national, multicenter, noninterventional, observational study. The primary endpoint included all clinical signs of a deep vein thrombosis (DVT) and/or pulmonary embolism during the prophylaxis and up to 48 h after discontinuation. The patients were treated 9-14 days on average.
RESULTS: There were few differences between the inpatients and the outpatients with respect to reduced mobility. However, the proportion of patients with infectious diseases was much higher in outpatients (53.8%) than in hospitalized patients (37.5%). The incidences of diseases of the musculoskeletal system (outpatients 20.9% vs. inpatients 7.3%) and acute congestive heart failure (outpatients 16.5% vs. inpatients 25.1%) were not balanced. During the observational period, primary endpoints were detected as clinical signs of a DVT in two outpatients aged > 65 years (0.3%) and were confirmed by ultrasound. Major bleedings were reported as secondary endpoints in only two hospitalized patients.
CONCLUSION: The results of this noninterventional study show that a primary prophylaxis with enoxaparin 40 mg in nonsurgical outpatients shows a similar safety profile compared to hospitalized medically ill patients.