Safety and Efficacy of Enoxaparin Compared With Unfractionated Heparin for Venous Thromboembolism Prophylaxis in Hemodialysis Patients.

Background: Enoxaparin, a low-molecular-weight heparin approved for prophylaxis in patients at risk for venous thromboembolism (VTE), offers several advantages compared with unfractionated heparin (UFH). Enoxaparin is primarily excreted through renal elimination and is currently not recommended in patients receiving hemodialysis (HD) due to potential increased bleeding complications. To date, there are limited safety and efficacy data supporting the use of enoxaparin in this patient population for VTE prophylaxis. Objective: The aim of this study was to compare the safety and efficacy of enoxaparin with UFH for deep venous thromboembolism (DVT) prophylaxis in medically ill HD patients. Methods and Results: This retrospective cohort study examined medically ill patients who received HD and were concomitantly prescribed enoxaparin or UFH for at least 2 consecutive days for VTE prophylaxis. A total of 225 patients (150 received UFH and 75 received enoxaparin) were evaluated in chronological order. The primary outcome was a composite of major, clinically relevant nonmajor, and minor bleeding based on International Society on Thrombosis and Haemostasis bleeding definitions. The secondary outcome was the occurrence of a confirmed thrombotic event. Baseline characteristics were similar between the cohorts. One patient in each cohort had a documented bleed (UFH = 0.7%, enoxaparin = 1.3%, P > .05) during the admission assessed; however, neither bleed was related to the prophylactic agent utilized. No patients developed a VTE during the index hospitalization. Conclusions: This study demonstrates that enoxaparin may be as safe and effective as UFH for VTE prophylaxis in medically ill patients receiving HD.

Evaluation of Apixaban for the Treatment of Nonvalvular Atrial Fibrillation With Regard to Dosing and Safety in a Community Hospital.

Background: Apixaban, a direct factor Xa inhibitor, is approved by the US Food and Drug Administration (FDA) for prevention of stroke and systemic embolism in nonvalvular atrial fibrillation. Apixaban's compelling safety and efficacy data, combined with minimal laboratory monitoring, make it an attractive anticoagulant. Objectives: To characterize and evaluate the dosing and safety of apixaban for the treatment of nonvalvular atrial fibrillation at a community hospital. Design/Patients: A retrospective chart review evaluated patients ≥18 years of age who received at least 2 consecutive doses of apixaban from January 1, 2013 to June 30, 2016. Patients with multiple admissions were evaluated for each hospitalization. Patients were excluded if height, weight, or serum creatinine was not documented during hospital admission. Patients who received apixaban for the treatment or prophylaxis of venous thromboembolism were excluded. Prescribing patterns were characterized based on FDA-approved dosing regimens and patient demographics. Safety outcomes included incidences of major, clinically relevant nonmajor, and minor bleeding. Results: Of the 707 patients evaluated, 82% received an FDA-approved apixaban regimen. Of the 127 patients (18%) who received an unapproved regimen, 5.5% (7 patients) received an unapproved frequency and 94.5% (120 patients) received an unapproved dose. The majority (98 patients, 81.7%) were underdosed. Composite bleeding rates were 2.7%, with 1.8% major bleeds, 0.7% clinically relevant nonmajor bleeds, and 0.1% minor bleeds. Conclusions: The use of apixaban must be monitored in order to ensure FDA-approved dosing regimens are being prescribed and patients are not being underdosed.

Analysis of enoxaparin dose titration at a large, tertiary teaching facility.

Therapeutic drug monitoring of enoxaparin with antifactor Xa levels (AXALs) is recommended in some populations; however, the approach to dose titration is poorly described. Our study at a large, tertiary teaching facility examined the dose response to titration of enoxaparin based on AXAL. Patients from 2008 to 2012 receiving enoxaparin were included, provided 2 or more steady state AXAL were obtained within 30 days and that the enoxaparin was prescribed for treatment rather than prophylaxis. The primary outcome was the percentage of dose change required to obtain goal range AXAL following dose titration. Eighty-seven patients were available for analysis with the following key characteristics: renal dysfunction during treatment 72%, obesity 8%, and solid organ transplant 26%. Initial goal AXAL was attained in 27 (31%) patients, and ultimately 54 (62%) patients achieved goal AXAL. Of the 31 patients who had initial AXAL above goal, 13 (42%) patients reached goal with a median dose decrease of 24%. In the 29 patients who had an initial AXAL below goal, 11 (38%) achieved therapeutic AXAL with a median dose increase of 16%. The AXAL monitoring can guide enoxaparin titration with subtherapeutic or supratherapeutic AXAL and an increase or decrease of roughly 20% is suggested as an initial change.