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• W110470758 abstract "Backgroundn Enoxaparin is a low molecular weight heparin used clinically to treat acute coronarynsyndromes and veno-thrombotic disorders. Dosing of enoxaparin is currently based onntotal body weight, with arbitrary reductions suggested for those with low total body mass.nIt is not known how to dose patients who are overweight or obese, which could lead toneither sub-therapeutic concentrations or overdosing. This thesis evaluated the effects ofnbody size on the pharmacokinetics / pharmacodynamics of enoxaparin, and evaluatednoptimal dosing strategies to achieve the desired goal.n n Methodsn Ninety six patients currently receiving therapy with enoxaparin at the Royal BrisbanenHospital were recruited into the study. Patients eligible for inclusion had to have normalnhepatic enzyme concentrations defined by values of liver enzymes within twice thennormal range (AST, ALT, ALP, gGT) and also normal values of bilirubin and albumin.nThey also had to have normal renal function with an estimated creatinine clearance ofngreater than or equal to 72 ml/min. Any patient with an intrinsic coagulation disordern(defined as pre-treatment abnormalities in their international normalised ratios (INR gn1.2) or recent childbirth were excluded from the study. Patients enrolled were stratifiednaccording to body mass index such that one third of patients studied had a body massnindex l24.9 kg/m2 (normal weight), one third from 25-29.9 kg/m2 (overweight) and onenthird g30 kg/m2 (obese). Patients were then randomly assigned to either an optimal ornempirical design group. Those in the optimal design group had three blood samples takennat times specified using a population D-optimal design. For the empirical sampling groupnthe twelve hour dose interval (for treatment doses) was divided into 3 groups. The timesnof the blood samples for the empirical design were stratified according to body massnindex. Sampling windows for both optimal and empirical designs and exactnadministration and sampling times were recorded. The occurrence of bruising was alsonnoted.n n Analysisn A standard three-stage population analysis for identification of covariates was used. Thenpopulation analysis was undertaken using the NONMEM (version 5) computer program n Resultsn A two compartment pharmacokinetic linear model with additive error provided the bestnfit to the total data set. Population mean values for clearance and central volumencompartment (p SE) were 0.9 (0.07) L/hr and 3.7(0.87) L respectively. Post hoc estimatesnof clearance for each patient were highly correlated with ideal body weight (r=0.427),nlean body weight (r=0.461) and sex. Volume of the central compartment was correlatednwith total body weight (r=0.47), body surface area (r=0.451) and body mass indexn(r=0.444). The second stage of analysis revealed that clearance was best described bynlean body weight and volume by total body weight. Logistic regression revealed thenprobability of bruising was best described by the maximum concentration of enoxaparinnand age.n Comparison of both the empirical and optimal design strategies were also undertaken.nThe empirical design supported a one compartment first order model, whilst the optimalndesign supported the full two compartment model. A predictive check revealed thenoptimal, empirical and total models were similar in precision, but the total model was lessnbiased. No statistically significant differences were observed between the models.n n Conclusionsn Manufacturer guidelines suggest enoxaparin should be dosed at 1001U/kg based on totalnbody weight every twelve hours. Our findings suggest that this dosing strategy is onlynsuitable for patients who weigh up to 120kg, and those above this weight should be dosednat 1001U/kg based on lean body weight given every eight hours.n The optimal design strategy supported a more complex model, than the empiricalnstrategy. Such techniques may be useful in the future to ensure the maximum amount ofninformation can be retrieved from pharmacokinetc and pharmacodynamic modelingnexperiments." @default.
• W110470758 created "2016-06-24" @default.
• W110470758 creator A5022819921 @default.
• W110470758 date "2002-01-01" @default.
• W110470758 modified "2023-09-27" @default.
• W110470758 title "Dosing of enoxaparin in obese patients" @default.
• W110470758 hasPublicationYear "2002" @default.
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