Epilepsy
Study register · detail Positionspapier / Best Practice Guideline · Epilepsy · 2008

Antiepileptic drugs—best practice guidelines for therapeutic drug monitoring: A position paper by the subcommission on therapeutic drug monitoring, ILAE Commission on Therapeutic Strategies

Unclear 1123 citations
SamplePositionspapier
EndpointClinical benefit of TDM
Blindingn.a.
DesignPositionspapier / Best Practice Guideline
Key finding

Position paper on therapeutic drug monitoring for antiepileptic drugs; randomised studies show no positive influence on clinical outcome, however non-randomised studies and clinical experience suggest a potential benefit when critically interpreted.

Summary

Best-practice guideline on therapeutic drug monitoring (TDM) for antiepileptic drugs. Although no RCTs show a positive influence on outcome, non-randomised studies and clinical experience demonstrate benefit of TDM in clear indications: (1) establishing individual therapeutic concentrations; (2) toxicity diagnosis; (3) compliance checking; (4) dose adjustment in cases of pharmacokinetic variability (children, elderly, pregnancy); (5) interaction management; (6) dose-dependent kinetics (phenytoin).

P
PopulationPatients with epilepsy under antiepileptic drug therapy (all age groups, including children, elderly people, pregnant women)
I
InterventionTherapeutic drug monitoring (TDM) of old and new antiepileptic drugs (serum level determination)
O
OutcomeNo randomised studies with positive evidence; non-randomised evidence and clinical experience demonstrate benefit in defined clinical situations (individual target concentration, toxicity diagnosis, compliance checking, pharmacokinetically variable constellations)
Quality profile
Sample size
Blinding
Effect size
Citations / year
Authors
Patsalos PN, Berry DJ, Bourgeois BFD, Cloyd JC, Glauser TA, Johannessen SI, Leppik IE, Tomson T, Perucca E
DOI 10.1111/j.1528-1167.2008.01561.x
Design: Positionspapier / Best Practice Guideline
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Abstract
Although no randomized studies have demonstrated a positive impact of therapeutic drug monitoring (TDM) on clinical outcome in epilepsy, evidence from nonrandomized studies and everyday clinical experience does indicate that measuring serum concentrations of old and new generation antiepileptic drugs (AEDs) can have a valuable role in guiding patient management provided that concentrations are measured with a clear indication and are interpreted critically, taking into account the whole clinical context. Situations in which AED measurements are most likely to be of benefit include (1) when a person has attained the desired clinical outcome, to establish an individual therapeutic concentration which can be used at subsequent times to assess potential causes for a change in drug response; (2) as an aid in the diagnosis of clinical toxicity; (3) to assess compliance, particularly in patients with uncontrolled seizures or breakthrough seizures; (4) to guide dosage adjustment in situations associated with increased pharmacokinetic variability (e.g., children, the elderly, patients with associated diseases, drug formulation changes); (5) when a potentially important pharmacokinetic change is anticipated (e.g., in pregnancy, or when an interacting drug is added or removed); (6) to guide dose adjustments for AEDs with dose-dependent pharmacokinetics, particularly phenytoin.

The impediment to action advances action. — Marcus Aurelius