Effectiveness and Tolerability of Fondaparinux vs Enoxaparin in a Population of Indian Patients with Symptomatic Deep Vein Thrombosis: A Retrospective Real-World Study

Abstract

Background Fondaparinux is the first approved anticoagulant drug among factor Xa inhibitors, with proven effectiveness and safety in preventing deep vein thrombosis. However, limited data are available supporting the benefit-risk profile of fondaparinux vs enoxaparin in a real-world group of Indian patients with deep vein thrombosis. Objective To compare the effectiveness and tolerability of fondaparinux vs enoxaparin in patients with symptomatic deep vein thrombosis in a long-term real-world setting. Methods Data from the electronic medical records of adult patients diagnosed with deep vein thrombosis prescribed fondaparinux (n = 503) or enoxaparin (n = 508) as monotherapy were analyzed. Effectiveness was analyzed in terms of recurrence, duration, and type of deep vein thrombosis event, and tolerability as bleeding events at initial hospitalization and follow-up visits up to 3 months duration. Appropriate statistical methods were used to determine the significance (p < 0.05) between the two groups. Results The deep vein thrombosis recurrence in the fondaparinux group was non-inferior (2.78%) when compared with enoxaparin (3.76%), with a mean duration of 47 and 48 days, respectively. The number of events and mean duration of events (in days) were not significant (p > 0.05). Major bleeding events were higher in the enoxaparin group at 3.17% than the fondaparinux group at 2.19%, and the difference was not statistically significant (p > 0.05). Conclusions The weight-based, once-daily subcutaneous fondaparinux dose showed non-inferior effectiveness and a comparable tolerability profile when compared with the twice-daily enoxaparin dose for the management of symptomatic deep vein thrombosis.

Efficacy of the bleeding risk scoring system for optimal prophylactic anticoagulation therapy of venous thromboembolism in trauma patients: a single-center, retrospective, observational cohort study

“…Non-major bleeding events have been previously reported in 13.2% of critically ill patients who received UFH as prophylactic anticoagulation therapy [ 20 ]. A recent real-world study reported minor bleeding events in 9.3% of patients who received fondaparinux or enoxaparin as anticoagulation therapy for symptomatic VTE [ 21 ]. The rate of minor bleeding events observed in this study was higher than that observed in the previous study, which may be attributed to patients presenting with trauma and a difference in the definition of bleeding.…”