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Anti-factor Xa activity of enoxaparin administered at prophylactic dosage to patients over 75 years old.

Abstract：

AIMS:Major bleeding complications with low-molecular-weight heparin (LMWH) treatment have been reported both in clinical studies and during postmarketing surveillance. Monitoring of antifactor Xa (anti-Xa) activities is therefore recommended in special populations often predisposed to renal impairment. The PROPHRE.75 study was conducted to estimate the distribution parameters of anti-Xa activity in the elderly. METHODS:PROPHRE.75 was a prospective study of a cohort of consecutive patients aged >75 years and treated with 4000 IU of enoxaparin once daily for venous thromboembolism prophylaxis. Dosing history and measurements of anti-Xa activity in sparse samples were recorded throughout treatment. The covariates included weight, gender, age, renal function, medical history and concomitant medication. Population parameters and interindividual variability were estimated using NONMEM V software. RESULTS:Anti-Xa activity was studied in 189 patients (mean age 82 +/- 5 years, 22% weighing <50 kg, 50% presenting renal impairment according to the Cockcroft and Gault formula). A first-order input two-compartment model best fitted the data. Clearance was significantly related to body weight and creatinine clearance based on the simplified Modification of Diet in Renal Disease formula, central volume being related to body weight. According to individual Bayesian estimations, 4% of patients presented with a peak anti-Xa activity >1.0 IU ml(-1), but this group did not include the sole patient experiencing a major bleed (0.53%). CONCLUSIONS:Systematic monitoring of anti-Xa activity in elderly patients treated with enoxaparin at prophylactic doses does not seem to be necessary to prevent the occurrence of major bleeding.

journal_name

Br J Clin Pharmacol

journal_title

British journal of clinical pharmacology

authors

Berges A,Laporte S,Epinat M,Zufferey P,Alamartine E,Tranchand B,Decousus H,Mismetti P,PROPHRE.75 Study Group.

doi

10.1111/j.1365-2125.2007.02920.x

subject

Has Abstract

pub_date

2007-10-01 00:00:00

pages

428-38

issue

eissn

0306-5251

issn

1365-2125

pii

BCP2920

journal_volume

pub_type

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Anti-factor Xa activity of enoxaparin administered at prophylactic dosage to patients over 75 years old.