Therapeutic Drug Monitoring of Newer Antiepileptic Drugs: A Randomized Trial for Dosage Adjustment
| Autor: | Thierry Buclin, Irene Aicua-Rapun, Philippe Ryvlin, Jan Novy, Pascal André, Andreas F. Hottinger, Laurent A. Decosterd, Andrea O. Rossetti |
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| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
Adult
Male 0301 basic medicine Topiramate Pediatrics medicine.medical_specialty Adolescent Current Literature in Clinical Science Aged Aged 80 and over Anticonvulsants/blood Anticonvulsants/pharmacokinetics Anticonvulsants/therapeutic use Dose-Response Relationship Drug Drug Monitoring/statistics & numerical data Epilepsy/blood Epilepsy/drug therapy Female Humans Middle Aged Single-Blind Method Treatment Outcome Young Adult Brivaracetam law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial law medicine Adverse effect Oxcarbazepine Epilepsy medicine.diagnostic_test business.industry 3. Good health 030104 developmental biology Neurology Tolerability Therapeutic drug monitoring Anticonvulsants Neurology (clinical) Levetiracetam Drug Monitoring business 030217 neurology & neurosurgery medicine.drug |
| Zdroj: | Annals of neurology, vol. 87, no. 1, pp. 22-29 Epilepsy Currents |
| Popis: | Therapeutic Drug Monitoring of Newer Antiepileptic Drugs: A Randomized Trial for Dosage AdjustmentAícua-Rapún I, André P, Rossetti AO, et al. Ann Neurol. 2020;87(1):22-29. doi:10.1002/ana.25641.Objective:Therapeutic drug monitoring (TDM) of antiepileptic drugs (AEDs) is widely established for older generation AEDs, whereas there is limited evidence about newer AEDs. Our aim is to assess the benefit of TDM of newer generation AEDs in epilepsy. Methods: We performed a randomized, controlled trial comparing systematic with rescue TDM of lamotrigine, levetiracetam, oxcarbazepine, topiramate, brivaracetam, zonisamide, or pregabalin. Participants were adults with epilepsy, in whom treatment with newer generation AEDs was initiated or needed adjustment. In the systematic TDM arm, AED plasma levels were available at each appointment, whereas in the rescue TDM arm, levels were known only if a study end point was reached (inefficacy or adverse events). The primary outcome was the proportion of participants who followed 1 year without reaching one of the predefined end points. Results: A total of 151 participants were enrolled; global retention in the study was similar in both arms (56% overall, 58% in the systematic, and 53% in the rescue TDM arm, P = .6, Cox regression). There was no difference in terms of outcome regarding treatment efficacy or tolerability. Partial adherence of clinicians to TDM (adjusting or not AED dosage based on blood levels) did not explain this lack of benefit. Interpretation: This study provides class A evidence that systematic drug-level monitoring of newer generation AEDs does not bring tangible benefits in the management of patients with epilepsy. Poor correlation between clinical effects and drug levels likely accounts for this finding. However, TDM is useful in several situations, such as pregnancy, as well as when there are compliance issues. |
| Databáze: | OpenAIRE |
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