Sanofi says that the study showed the benefit of extended prophylaxis in acutely ill medical patients with reduced mobility by demonstrating the superiority of a five week course of prophylaxis with Clexane/Lovenox (enoxaparin)compared to a 10 day regimen, with a statistically significant 44% reduction in venous thromboembolism (VTE) events (deep vein thrombosis and/or pulmonary embolism).
The benefit of thromboprophylaxis with enoxaparin (10 plus or minus 4 days) has already been demonstrated in this patient population and is considered as the standard regimen, says Sanofi. Nonetheless, clinical practice suggests that the risk of VTE may continue beyond 10 days, particularly in patients with reduced mobility.
The objective of the study was to assess the superiority of enoxaparin prophylaxis given for 28 plus or minus 4 days versus placebo, both following an initial treatment with enoxaparin for 10 plus or minus 4 days, to reduce VTE events rate. The primary efficacy endpoint was the incidence of asymptomatic deep-vein thrombosis (DVT), symptomatic DVT, symptomatic pulmonary embolism (PE), or fatal PE during the double-blind period.
The statistically significant 44% relative risk reduction in VTE events observed for extended-duration prophylaxis with enoxaparin vs. placebo for the primary endpoint was associated with a reduction in symptomatic VTE by 73% and asymptomatic proximal DVT by 34%. No statistically significant differences were observed for symptomatic pulmonary embolism (PE) or fatal PE.
“What the trial results showed is that patients do not leave their risk for VTE at the door when they leave the hospital,” commented Victor Tapson, a lead investigator of the study.