Lacosamide Therapeutic Monitoring in Patients With Epilepsy

Contin, Manuela; Riva, R.; Albani, Fiorenzo; Avoni, Patrizia; Baruzzi, Agostino

doi:10.1097/ftd.0b013e318290eacc

Cited by 58 publications

(9 citation statements)

References 13 publications

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“… 30 , 31 A Norwegian study with 344 patients and an Italian study with 75 patients found that nearly all patients with good therapeutic effect had drug-fasting serum concentrations within a range of 10–40 μmol/L (3–10 mg/L). 32 , 33 We, therefore, recommend that the current reference range remains unchanged.…”

Section: Resultsmentioning

confidence: 99%

Reference ranges for antiepileptic drugs revisited: a practical approach to establish national guidelines

Reimers¹,

Berg²,

Burns³

et al. 2018

DDDT

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Background and objectiveLaboratories sometimes use different reference ranges for the same antiepileptic drug (AED), particularly for new and poorly investigated drugs. This may contribute to misunderstandings, concerns or inappropriate dose changes, which in turn may affect therapeutic effect, drug safety or treatment adherence. Therefore, the Norwegian Association of Clinical Pharmacology wished to update and harmonize the reference ranges for AEDs and establish national guidelines for Norway.MethodsA working group collected information on the reference ranges used by Norwegian laboratories for all commonly used AEDs. These reference ranges were compared to recent recommendations by the International League Against Epilepsy, current literature, applicable clinical studies, reference ranges used by leading Northern European epilepsy centers outside of Norway, and routine data derived from Norwegian laboratory databases.ResultsReference ranges varied between laboratories for four of 23 available AEDs (lamotrigine, valproate, eslicarbazepine and oxcarbazepine). For four AEDs (brivaracetam, perampanel, stiripentol and sulthiame), reference ranges had not previously been established. In total, 13 reference ranges were either harmonized, updated or newly established. No changes were applied to the remaining 10 AEDs.ConclusionUpdated and harmonized reference ranges are now available for 22 of the 23 AEDs available in Norway. The exception is vigabatrin (reference range not applicable). Revision of reference ranges is an important part of pharmacovigilance of AEDs and must be a continuous process based on current literature and clinical experience.

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Section: Resultsmentioning

confidence: 99%

Reference ranges for antiepileptic drugs revisited: a practical approach to establish national guidelines

Reimers¹,

Berg²,

Burns³

et al. 2018

DDDT

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“…The use of perchloric acid to deproteinize [14] was also avoided. The deproteinization with methanol described by Contin M, et al [10] was performed, but a pressure increase was observed in the chromatographic system after a small number of samples were injected. Thus, pretreatment with methanol was abandoned.…”

Section: Discussionmentioning

confidence: 99%

“…Good chromatographic separation was achieved when preparing the potassium dihydrogen phosphate buffer at a concentration of 10 mM instead of 50 mM [10], contributing to the use of less reagents. The flow rate of the mobile phase in the present method was lower than in other methods of 0.8 mL/min [9], 1 mL/min [7,12,19], 1.2 mL/min [13,14], and 1.5 mL/min [10]. Besides, other methods have longer runtimes of 10 [9], 14 [10], 17 [12] and 18 minutes [14].…”

Section: Discussionmentioning

confidence: 99%

“…TDM of levetiracetam is performed in some centers around the world with a typical plasma concentration targeted between 12 and 46 µg/mL [3]. The objective of this study was to adapt an HPLC-UV method to quantify levetiracetam in plasma based on previously published techniques [7][8][9][10][11][12][13][14], to provide an affordable analysis for routine use in a low-source setting, directed to the therapeutic monitoring of levetiracetam in patients with epilepsy.…”

Section: Introductionmentioning

confidence: 99%

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Determination of Levetiracetam in Plasma by a Modified HPLC-UV Method and Its Pharmacokinetic Application

Hernández-Mitre¹,

Medellín‐Garibay²,

Rodríguez‐Leyva³

et al. 2020

Mathews Journal of Pharmaceutical Science

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Levetiracetam is a very effective antiepileptic which has been pointed out as a drug that should be monitored, despite its almost ideal pharmacokinetics.The objective was to adapt an HPLC-UV method to quantify levetiracetam in plasma based on previously published techniques, to provide an affordable analysis for routine use in a low-source setting. Pretreatment of plasma samples consisted of a deproteinization with acetonitrile. The analytical conditions implemented were a mobile phase of potassium dihydrogen phosphate buffer (10 mM, pH-4.6)/acetonitrile(93:7 v/v) at an isocratic flow rate of 0.5 mL/min, and UV detection at 192 nm. The retention time for levetiracetam was 7.45 min. Total runtime of the analysis was 9 min. The method was linear in the range of 5-60 µg/mL, repeatable and reproducible (CV<15%). Recovery was above 80%. The limit of detection was 0.19 µg/mL.The method was applied to determine levetiracetam concentration in plasma of 10 patients with epilepsy, and pharmacokinetic parameters Cmax, Tmax, AUC 0-t , AUC 0-∞ , and t 1/2 were estimated. The described method represents an alternative for laboratories interested in implementing therapeutic monitoring of levetiracetam that lack sophisticated equipment and have limited access to supplies employed in other published methods.

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“…Population pharmacokinetic data from phase II clinical studies of lacosamide have shown that lamotrigine, levetiracetam, topiramate, oxcarbazepine, and VPA have no significant effects on the pharmacokinetics of lacosamide [65]. Enzyme inducers such as carbamazepine and phenytoin can significantly reduce plasma lacosamide concentrations and thereby enhance clearance [66, 67]. Although data are limited, overall, lacosamide does not affect the pharmacokinetics of many AEDs [60].…”

Section: Newest Antiepileptic Drugsmentioning

confidence: 99%

An Updated Overview on Therapeutic Drug Monitoring of Recent Antiepileptic Drugs

2016

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Given the distinctive characteristics of both epilepsy and antiepileptic drugs (AEDs), therapeutic drug monitoring (TDM) can make a significant contribution to the field of epilepsy. The measurement and interpretation of serum drug concentrations can be of benefit in the treatment of uncontrollable seizures and in cases of clinical toxicity; it can aid in the individualization of therapy and in adjusting for variable or nonlinear pharmacokinetics; and can be useful in special populations such as pregnancy. This review examines the potential for TDM of newer AEDs such as eslicarbazepine acetate, felbamate, gabapentin, lacosamide, lamotrigine, levetiracetam, perampanel, pregabalin, rufinamide, retigabine, stiripentol, tiagabine, topiramate, vigabatrin, and zonisamide. We describe the relationships between serum drug concentration, clinical effect, and adverse drug reactions for each AED as well as the different analytical methods used for serum drug quantification. We discuss retrospective studies and prospective data on the serum drug concentration–efficacy of these drugs and present the pharmacokinetic parameters, oral bioavailability, reference concentration range, and active metabolites of newer AEDs. Limited data are available for recent AEDs, and we discuss the connection between drug concentrations in terms of clinical efficacy and nonresponse. Although we do not propose routine TDM, serum drug measurement can play a beneficial role in patient management and treatment individualization. Standardized studies designed to assess, in particular, concentration–efficacy–toxicity relationships for recent AEDs are urgently required.

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Lacosamide Therapeutic Monitoring in Patients With Epilepsy

Cited by 58 publications

References 13 publications

Reference ranges for antiepileptic drugs revisited: a practical approach to establish national guidelines

Reference ranges for antiepileptic drugs revisited: a practical approach to establish national guidelines

Determination of Levetiracetam in Plasma by a Modified HPLC-UV Method and Its Pharmacokinetic Application

An Updated Overview on Therapeutic Drug Monitoring of Recent Antiepileptic Drugs

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