title: Enoxaparin outcomes in patients with moderate renal impairment.
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.
authors.affiliation: Pharmacy Service, Minneapolis Veterans Affairs Health Care System, Minneapolis, Minnesota 55417, USA. douglas.decarolis@va.gov
authors.forename: Douglas D
authors.initials: DD
authors.lastname: DeCarolis
authors.forename: Joey G
authors.initials: JG
authors.lastname: Thorson
authors.forename: Megan A
authors.initials: MA
authors.lastname: Clairmont
authors.forename: Amy M
authors.initials: AM
authors.lastname: Leuthner
authors.forename: Thomas S
authors.initials: TS
authors.lastname: Rector
authors.forename: Gerhard J
authors.initials: GJ
authors.lastname: Johnson
mesh_terms: D000368:Aged; D000925:Anticoagulants / Q000008:administration & dosage; D003404:Creatinine / Q000378:metabolism; D004305:Dose-Response Relationship, Drug; D017984:Enoxaparin / Q000008:administration & dosage*; D005260:Female; D005500:Follow-Up Studies; D005919:Glomerular Filtration Rate / Q000187:drug effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D051437:Renal Insufficiency / Q000150:complications* / Q000378:metabolism / Q000503:physiopathology; D012189:Retrospective Studies; D013923:Thromboembolism / Q000150:complications / Q000188:drug therapy*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000925:Anticoagulants; D017984:Enoxaparin; D003404:Creatinine