A decade after MEDENOX study that established the benefit of enoxaparin based short term prophylaxis in acutely ill medical patients, EXCLAIM is building in this paradigm and highlighting even further the necessity to optimising enoxaparin thromboprophylaxis according to patients' venothrombotic risks" added Pr Samama, from Hotel-Dieu Hospital Paris, member of the EXCLAIM study Steering Committee
Similarly to the initial demonstration of the benefit of thromboprophylaxis for acutely ill medical patients, first established by the MEDENOX trial, the EXCLAIM study should be a landmark trial in advancing the standard of care of patients at high risk for VTE and it further establishes enoxaparin as a reference treatment for VTE prophylaxis in acutely ill medical patients.
The results of EXCLAIM will expand on the earlier MEDENOX (Prophylaxis in MEDical patients with ENOXaparin) study, which found that daily 40-mg subcutaneous injections of Lovenox for six to 14 days reduced the incidence of VTE in acutely ill medical patients during hospitalization by 63 percent compared with placebo, without increasing the risk of major hemorrhage.
About Venous Thromboembolism (VTE) and the MEDENOX study
The significant clinical benefit of routine prophylaxis using Lovenox, a low-molecular-weight heparin (LMWH), to prevent VTE in acutely ill medical patients was demonstrated in the MEDENOX study.
According to the MEDENOX (MEDical patients with ENOXaparin) study published in The New England Journal of Medicine (Samama, 1999), hospitalized acutely ill medical (non-surgical) patients are at significant risk for venous thromboembolic events (deep-vein thrombosis or pulmonary embolism), and prophylaxis with Lovenox significantly reduces the risk across a range of patient categories.
The MEDENOX study is a phase III multicenter, three-parallel-group (enoxaparin 20 mg and 40 mg once daily and placebo), randomized, double-blind, placebo-controlled study involving 1,102 patients from 60 centers in nine countries.