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Enoxaparin Dosing and Associated Risk of In-Hospital Bleeding and Death in Patients With Non–ST-Segment Elevation Acute Coronary Syndromes
Nancy M. Allen LaPointe, PharmD;
Anita Y. Chen, MS;
Karen P. Alexander, MD;
Matthew T. Roe, MD, MHS;
Charles V. Pollack Jr, MD, MA;
Barbara L. Lytle, MS;
Magnus E. Ohman, MD;
Brian W. Gibler, MD;
Eric D. Peterson, MD, MPH
Arch Intern Med. 2007;167(14):1539-1544.
Background The efficacy of enoxaparin sodium in non–ST-segment elevation acute coronary syndromes is well established; however, concerns remain regarding bleeding risk. The extent to which bleeding risk is attributable to excess dosing of enoxaparin is unclear.
Methods Using data from the CRUSADE (Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes With Early Implementation of the ACC/AHA Guidelines) National Quality Improvement Initiative, we determined the frequency of administration of excess (>10 mg above the recommended dose), lower-than-recommended (>10 mg below the recommended dose), and recommended doses of enoxaparin. We also determined unadjusted and adjusted risks of in-hospital major bleeding and death associated with excess and lower-than-recommended doses of enoxaparin.
Results Of 10 687 patients, 2002 (18.7%) received an excess dose and 3116 (29.2%) received a lower-than-recommended dose of enoxaparin. Patients receiving excess doses were older (median age, 78 vs 66 years), smaller (median body mass index [calculated as weight in kilograms divided by height in meters squared], 26.2 vs 27.8), and more likely to be female (59.5% vs 38.2%) than patients receiving recommended doses (P < .001 for all). After adjustment for baseline characteristics, an excess dose was significantly associated with major bleeding (odds ratio, 1.43; 95% confidence interval [CI], 1.18-1.75) and death (odds ratio, 1.35; 95% CI, 1.03-1.77) compared with a recommended dose. A lower-than-recommended dose was not associated with major bleeding (odds ratio, 1.01; 95% CI, 0.84-1.21), but there was a trend toward higher mortality (odds ratio, 1.25; 95% CI, 0.93-1.68).
Conclusions Almost half the patients treated with enoxaparin did not receive a recommended dose and had worse outcomes, especially those receiving an excess dose. Improved adherence to the recommended dose could substantially improve the safety profile of enoxaparin.
Author Affiliations: Duke Clinical Research Institute (Drs Allen LaPointe, Alexander, Roe, Ohman, and Peterson and Mss Chen and Lytle) and Divisions of Clinical Pharmacology (Dr Allen LaPointe) and Cardiology (Drs Alexander, Roe, Ohman, and Peterson), Duke University Medical Center, Durham, North Carolina; Department of Emergency Medicine, Pennsylvania Hospital, University of Pennsylvania School of Medicine, Philadelphia (Dr Pollack); and Department of Emergency Medicine, University of Cincinnati College of Medicine, Cincinnati, Ohio (Dr Gibler).
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