Key result
Daily enoxaparin achieves target antifactor Xa levels in ~74% of severe CKD patients without major bleeding.
Why the study?
The safety and efficacy, as measured by antifactor Xa levels, of subcutaneous enoxaparin 1 mg/kg once every 24 hours required evaluation in patients with severe renal failure.
Does enoxaparin 1 mg/kg subcutaneously once every 24 hours achieve safe and effective antifactor Xa levels in patients with stage 4 or 5 chronic kidney disease requiring full anticoagulation?
Cohort (n=19)
No
Does enoxaparin 1 mg/kg subcutaneously once every 24 hours achieve safe and effective antifactor Xa levels in patients with stage 4 or 5 chronic kidney disease requiring full anticoagulation?
Enoxaparin 1 mg/kg subcutaneously once every 24 hours safely achieved therapeutic peak antifactor Xa concentrations without supratherapeutic levels or major bleeding in patients with stage 4 or 5 chronic kidney disease.
Answers are grounded in this paper and cite their sources.
May support enoxaparin 1 mg/kg daily dosing in severe CKD; leaves open confirmation of safety and efficacy in larger trials.
Study Objective. To evaluate the safety and efficacy by measuring antifactor Xa levels, of enoxaparin 1 mg/kg subcutaneously once every 24 hours in patients with severe renal failure. Design. Prospective study. Setting. Emergency, internal medicine, geriatrics, and cardiology departments of a medical center in Israel. Patients. Nineteen patients with stage 4 or 5 chronic kidney disease who required full anticoagulation. Intervention. Patients received enoxaparin 1 mg/kg subcutaneously every 24 hours for 2 or more days, as determined by a treating physician. Measurements and Main Results. Data on patients' demographic and clinical characteristics were collected. Blood samples for peak and trough antifactor Xa levels were obtained during the enoxaparin treatment period. Of the 19 study patients, 14 (74%) had peak antifactor Xa levels within the recommended range for full anticoagulation of 0.5‐1.0 U/ml after their first enoxaparin dose; no concentration exceeded 1.0 U/ml. The mean peak antifactor Xa level was not significantly different after the first enoxaparin dose compared with the second and third doses. The mean ± SD trough antifactor Xa level, thought to be an indicator of drug accumulation, was 0.12 ± 0.12 U/ml; its clinical significance and target range are still unknown. No major bleeding events were noted. Conclusion. Enoxaparin 1 mg/kg once every 24 hours in patients with stage 4 or 5 chronic kidney disease who required full anticoagulation was safe, and this dose did not exceed recommended concentrations. The significance of enoxaparin trough levels remains unclear and should be investigated in future studies. Other dosing regimens of enoxaparin for specific patient populations should also be assessed for safety and efficacy.
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Lachish et al. (2007) conducted a cohort in Stage 4 or 5 chronic kidney disease requiring full anticoagulation (n=19). Enoxaparin was evaluated on Peak antifactor Xa levels within the recommended range for full anticoagulation (0.5-1.0 U/ml) after the first dose. Enoxaparin 1 mg/kg every 24 hours achieved target peak antifactor Xa levels (0.5-1.0 U/ml) in 74% (14/19) of patients with stage 4 or 5 CKD, with no major bleeding.
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