Enoxaparin does not reduce mortality in acutely ill medical patients
MedWire News: Pharmacologic thromboprophylaxis with the low molecular weight heparin enoxaparin does not reduce mortality among hospitalized acutely ill medical patients already using elastic stockings with compression, study findings indicate.
"Although thromboprophylaxis reduces the incidence of venous thromboembolism (VTE) in acutely ill medical patients, an associated reduction in the rate of death from any cause has not been shown," note Ajay Kakkar (University College London, UK) and colleagues.
The researchers therefore evaluated the effect of pharmacologic thromboprophylaxis on the rate of death from any cause among 8307 hospitalized acutely ill medical patients from 193 sites in China, India, Korea, Malaysia, Mexico, the Philippines, and Tunisia.
Patients who were at least 40 years of age and hospitalized for acute decompensated heart failure, severe systemic infection with at least one risk factor for VTE, or active cancer, were randomly assigned to receive enoxaparin 40 mg daily plus elastic stockings with graduated compression (n=4171) or placebo plus elastic stockings with graduated compression (n=4136) for 6 to 14 days (median=6 days).
Kakkar and team report that there was no significant difference between the groups in the primary efficacy outcome of all-cause mortality at 30 days after randomization. Specifically, the mortality rate was 4.9% in the enoxaparin group compared with 4.8% in the placebo group.
The primary safety outcome - major bleeding during and up to 48 hours after the treatment period - also did not differ between the groups, at 0.4% for enoxaparin and 0.3% for placebo. However, the rate of minor bleeding was significantly higher with enoxaparin than with placebo (1.8 vs 1.1%).
In addition, the two groups did not differ significantly with respect to the rate of either serious adverse events (5.8 vs 5.3% for enoxaparin vs placebo) or adverse events leading to death (2.9vs 2.9%).
"One possible explanation for our findings is that the use of elastic stockings with graduated compression alone is effective in preventing venous thromboembolism, thus reducing the frequency of fatal pulmonary embolism," write Kakkar and co-authors in the New England Journal of Medicine.
In addition, "multiple coexisting illnesses and numerous other potential causes of death in medical patients might make fatal pulmonary embolism a less important determinant of mortality in this group than in surgical patients, thus diminishing the ability of pharmacologic prophylaxis to improve the overall clinical outcome."
MedWire (http://www.medwire-news.md/) is an independent clinical news service provided by Springer Healthcare Limited. © Springer Healthcare Ltd; 2011
By Laura Dean