What question did this study set out to answer?

To investigate the influence of glomerular filtration rate on subcutaneous enoxaparin pharmacokinetics and develop a practical bedside dosing algorithm for patients with renal impairment presenting with acute coronary syndromes.

January 20, 2005British Journal of Clinical PharmacologyOpen Access

Dosing strategy for enoxaparin in patients with renal impairment presenting with acute coronary syndromes

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Why the study?

How does GFR influence the pharmacokinetics of subcutaneously administered enoxaparin in patients with acute coronary syndromes?

Population

38 patients presenting with acute coronary syndrome, median age 78 years, mean GFR 32 ml min and mean weight…

Design

Cohort

Follow-up

over their period of therapy

Authors

BGB. GreenRoyal Brisbane and Women's Hospital MGMichael J. GreenwoodWashington State University DSDavid SaltissiRoyal Brisbane and Women's Hospital

Discussion

Member takes

Implication

Supports initial standard enoxaparin dosing across GFR levels in ACS; leaves open randomized confirmation of safety beyond 48 h.

Key Points

To investigate the influence of glomerular filtration rate on subcutaneous enoxaparin pharmacokinetics and develop a practical bedside dosing algorithm for patients with renal impairment presenting with acute coronary syndromes.
Recruited 38 patients (median age 78 years, mean glomerular filtration rate 32 ml min⁻¹) presenting with acute coronary syndrome and collected 313 anti-Xa concentration samples across treatment.
Constructed a population pharmacokinetic model using non-linear mixed-effects modeling (NONMEM) and conducted stochastic simulations to identify optimal dosing strategies.
A two-compartment first-order input model identified linear relationships between glomerular filtration rate and clearance (CL = 0.681 per 4.8 l h⁻¹ GFR + 0.229) and between total body weight and central volume (Vc = 5.22 per 80 kg), with 71% of the drug excreted unchanged.
Simulations demonstrated that standard dosing of 1.0 mg kg⁻¹ every 12 hours requires no dose reduction during the first 48 hours of treatment, after which maintenance doses should be adjusted proportionally based on renal excretion fraction.

Structured PICO

How does GFR influence the pharmacokinetics of subcutaneously administered enoxaparin in patients with acute coronary syndromes?

Population

38 patients presenting with acute coronary syndrome, median age 78 years (range 44-87), mean GFR 32 ml min(-1) (range 16-117) and mean weight 69 kg (range 32-95)

Intervention

Subcutaneously administered enoxaparin

Outcome

Pharmacokinetics of enoxaparin (anti-Xa concentrations) and development of a dosing algorithmsurrogate

In patients with ACS and renal impairment, standard enoxaparin dosing (1.0 mg/kg 12 hourly) requires no adjustment for the first 48 hours, after which maintenance doses should be proportionally adjusted based on GFR.

Cite This Study

Green et al. (2005) studied this question.

synapsesocial.com/papers/6a6fecfbfebe604dd708bf3b https://doi.org/10.1111/j.1365-2125.2004.02253.x

Topics

Anticoagulation in AF

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Dosing strategy for enoxaparin in patients with renal impairment presenting with acute coronary syndromes

Discussion

Member takes

Implication

Key Points

Structured PICO

Cite This Study

Topics

Dosing strategy for enoxaparin in patients with renal impairment presenting with acute coronary syndromes

Discussion

Member takes

Implication

Key Points

Structured PICO

Cite This Study

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Topics

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