Customize your JAMA Network experience by selecting one or more topics from the list below.
Identify all potential conflicts of interest that might be relevant to your comment.
Conflicts of interest comprise financial interests, activities, and relationships within the past 3 years including but not limited to employment, affiliation, grants or funding, consultancies, honoraria or payment, speaker's bureaus, stock ownership or options, expert testimony, royalties, donation of medical equipment, or patents planned, pending, or issued.
Err on the side of full disclosure.
If you have no conflicts of interest, check "No potential conflicts of interest" in the box below. The information will be posted with your response.
Not all submitted comments are published. Please see our commenting policy for details.
It would be very interesting to know the kind of major bleeding observed in patients submitted to bridging therapy. Is the observed bleeding related to the invasive procedure? And if so, was the last dose of enoxaparine stopped at least 24 hours before the procedure? And how many hours after the procedure has the enoxaparine been reassumed?
DeCarolis DD, Thorson JG, Clairmont MA, Leuthner AM, Rector TS, Johnson GJ. Enoxaparin Outcomes in Patients With Moderate Renal Impairment. Arch Intern Med. 2012;172(22):1713–1718. doi:10.1001/2013.jamainternmed.369
Author Affiliations: Pharmacy Service (Drs DeCarolis, Thorson, Clairmont, and Leuthner), Center for Chronic Disease Outcomes Research (Dr Rector), and Hematology/Oncology Section (Dr Johnson), Minneapolis Veterans Affairs Health Care System, Minneapolis, Minnesota.
Background Enoxaparin sodium has predictable pharmacokinetics that allow for simplified dosing without laboratory monitoring. Reliance on renal function for excretion may lead to accumulation of enoxaparin in patients with moderate renal impairment. However, there is no dose adjustment recommended for these patients. We conducted a review to compare bleeding events in patients with moderate renal impairment compared with those with normal renal function.
Methods Patients received enoxaparin sodium, 1 mg/kg, every 12 hours or 1.5 mg/kg once daily between June 1 and November 30, 2009. Moderate renal impairment was defined as creatinine clearance (CrCl) of 30 to 50 mL/min. Normal renal function was defined as CrCl greater than 80 mL/min. The primary outcome was major bleeding, defined as any bleeding resulting in death, hospital admission, lengthened hospital stay, or an emergency department visit. The secondary outcome was thromboembolism.
Results A total of 164 patients met the inclusion criteria: 105 with normal renal function and 59 with moderate renal impairment. The primary outcome occurred in 6 of 105 patients (5.7%) with normal renal function vs 13 of 59 patients (22.0%) with moderate renal impairment, representing an unadjusted odds ratio of 4.7 (95% CI, 1.7-13.0; P = .002). The odds ratio using multivariable logistic regression adjusting for differences in risk was 3.9 (95% CI, 0.97-15.6; P = .055). There was no recurrent thromboembolism in either group.
Conclusions Our results suggest an increased risk of major bleeding in patients with moderate renal impairment who receive enoxaparin. Because enoxaparin is frequently used and outcomes can be life saving or life threatening, we encourage further study of the appropriate dose in patients with moderate renal impairment.
Create a personal account or sign in to: