Concern over enoxaparin bleeding risk in patients with moderate renal impairment

Dec 14 2012

By Liam Davenport, medwireNews Reporter

The low molecular weight heparin enoxaparin is associated with an increased risk for major bleeding in patients who have moderate renal impairment, say US scientists in findings that have prompted calls for updates to dosing recommendations.

The team, led by Douglas DeCarolis, from Minneapolis Veterans Affairs Health Care System in Minnesota, comments: "When our results are added to previous evidence and the pharmacokinetics of enoxaparin, we believe that there are ample data confirming enoxaparin accumulation and an increased risk of major bleeding in patients with moderate renal impairment."

In an accompanying commentary in the Archives of Internal Medicine, Tracy Minicheillo (University of California, San Francisco, USA) says: "The work by DeCarolis and colleagues adds to an important body of work that should lead clinicians to take caution with the use of enoxaparin in patients with moderate renal impairment, particularly in the perioperative period, and to insist on an evidence-based update of current dosing recommendations for patients receiving any anticoagulant that is renally cleared."

The team studied 164 patients who received enoxaparin sodium 1 mg/kg every 12 hours or 1.5 mg/kg once daily either during a hospital inpatient stay or as an outpatient prescription. Fifty-nine patients had moderate renal impairment, defined as creatinine clearance (CrCl) of 30-50 mL/min, while 105 had normal renal function, defined as CrCl of more than 80 mL/min.

The mean duration of enoxaparin treatment was slightly longer in patients with normal renal function than in those with moderate renal impairment, at 12.8 days versus 11.9 days. Major bleeding occurred in 5.7% of normal renal function patients versus 22.0% of those with moderate renal impairment.

Multivariate logistic regression analysis revealed that the odds ratio for major bleeding with enoxaparin treatment in patients with moderate renal impairment was 3.9 compared with those with normal renal function.

Bleeding was more common in patients undergoing bridge therapy than in those receiving new anticoagulation, at 13.7% versus 8.7%, and was similar in both renal groups. Interestingly, there was a high rate of major bleeding in patients undergoing cardiac ablation procedures and receiving bridge enoxaparin therapy at standard doses, at 29.4%. Excluding these patients did not have a major impact on major bleeding rates among patients with moderate renal impairment.

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