Clinical Investigations: Acute Ischemic Heart DiseaseInfluence of patient characteristics and renal function on factor Xa inhibition pharmacokinetics and pharmacodynamics after enoxaparin administration in non-ST-segment elevation acute coronary syndromes*
Section snippets
Methods
The TIMI 11A study, a multicenter dose-ranging trial to evaluate the safety of enoxaparin (Lovenox, Aventis Pharmaceuticals, Bridgewater, NJ) in the treatment of patients with non-ST-segment elevation ACS, has been published previously.11 In brief, patients initially received a full complement of antiischemic medications (β-blocker, nitrate, calcium channel antagonist) and a 30-mg intravenous bolus of enoxaparin, followed immediately by weight-adjusted (actual) doses of either 1 mg/kg or 1.25
Baseline characteristics
Blood samples were obtained from 445 patients with unstable angina and non-ST-segment elevation myocardial infarction for anti-Xa determination. The baseline characteristics for the overall study population and according to creatinine clearance are summarized in Table I.Empty Cell All patients (n = 445) Creatinine clearance <40 (n = 11) Creatinine clearance 40-80 (n = 149) Creatinine
Discussion
The emergence of encouraging data derived from large-scale, randomized clinical trials,15, 16, 17, 18 coupled with several attractive features including ease of administration and excellent bioavailability, are responsible for the acceptance of LMWH as standard treatment among patients with venous and, more recently, arterial thrombotic disorders.19, 20, 21 Although fixed (1.0 mg/kg) weight-adjusted dosing is appropriate for most patients with ACS, our findings suggest that, in contrast to
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Reprint requests: Richard C. Becker, MD, Director, Cardiovascular Thrombosis Research Center, University of Massachusetts Medical School, Worcester, MA 01655.