Enoxaparin Outcomes in Patients With Moderate Renal Impairment
Open Access
- 10 December 2012
- journal article
- research article
- Published by American Medical Association (AMA) in JAMA Internal Medicine
- Vol. 172 (22), 1713-1718
- https://doi.org/10.1001/2013.jamainternmed.369
Abstract
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.Keywords
This publication has 28 references indexed in Scilit:
- Individualized Dosing of Enoxaparin for Subjects With Renal Impairment Is Superior to Conventional Dosing at Achieving Therapeutic ConcentrationsTherapeutic Drug Monitoring, 2010
- Individualized Compared With Conventional Dosing of EnoxaparinClinical Pharmacology & Therapeutics, 2007
- Dosage of enoxaparin among obese and renal impairment patientsThrombosis Research, 2005
- Dosing strategy in patients with renal failure receiving enoxaparin for the treatment of non-ST-segment elevation acute coronary syndromeClinical Pharmacology & Therapeutics, 2005
- Dosing strategy for enoxaparin in patients with renal impairment presenting with acute coronary syndromesBritish Journal of Clinical Pharmacology, 2005
- Effect of Renal Function on the Pharmacokinetics of Enoxaparin and Consequences on Dose AdjustmentTherapeutic Drug Monitoring, 2004
- Population pharmacokinetics and pharmacodynamics of enoxaparin in unstable angina and non-ST-segment elevation myocardial infarctionBritish Journal of Clinical Pharmacology, 2003
- Influence of patient characteristics and renal function on factor Xa inhibition pharmacokinetics and pharmacodynamics after enoxaparin administration in non-ST-segment elevation acute coronary syndromesAmerican Heart Journal, 2002
- Pharmacokinetics and pharmacodynamics of the prophylactic dose of enoxaparin once daily over 4 days in patients with renal impairmentThrombosis Research, 2002
- Enoxaparin and Bleeding Complications: A Review in Patients with and without Renal InsufficiencyPharmacotherapy: The Journal of Human Pharmacology and Drug Therapy, 2000