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1. Symptomatology of carbamazepine- and oxcarbazepine-induced hyponatremia in people with epilepsy.

Author

Berghuis B, Hulst J, Sonsma A, McCormack M, de Haan GJ, Sander JW, Lindhout D, and Koeleman BPC

Subjects
Adult, Anticonvulsants therapeutic use, Carbamazepine therapeutic use, Dizziness chemically induced, Dizziness etiology, Fatigue chemically induced, Fatigue etiology, Female, Humans, Hyponatremia blood, Hyponatremia complications, Male, Middle Aged, Oxcarbazepine therapeutic use, Retrospective Studies, Sodium blood, Anticonvulsants adverse effects, Carbamazepine adverse effects, Epilepsy drug therapy, Hyponatremia chemically induced, Oxcarbazepine adverse effects
Abstract

Objective: To ascertain whether adverse effects experienced by people taking carbamazepine or oxcarbazepine could be attributed to carbamazepine- or oxcarbazepine-induced hyponatremia (COIH)., Methods: We performed an observational study, collecting data between 2017 and 2019 on serum sodium levels and adverse effects retrospectively in people with epilepsy while receiving treatment with either carbamazepine (CBZ) or oxcarbazepine (OXC). We defined hyponatremia as sodium level ≤134 mEq/L and severe hyponatremia as sodium level ≤128 mEq/L. Adverse effects experienced were compared between groups of individuals with and without hyponatremia., Results: A total of 1370 people using CBZ or OXC were identified, of whom 410 had at least one episode of hyponatremia. We checked for symptoms related to the use of CBZ and OXC in 710 people (410 with and 300 without hyponatremia) and found relevant information in 688. Adverse effects occurred in 65% of people with hyponatremia compared to 21% with normal sodium levels (odds ratio [OR] 7.5, P ≤ .001) and in 83% of people with severe hyponatremia compared to 55% in those with mild hyponatremia (P ≤ .001). Significant predictors of adverse effects were the drug (OXC vs CBZ), and the number of concomitant anti-seizure medications. Dizziness (28% vs 6%), tiredness (22% vs 7%), instability (19% vs 3%), and diplopia (16% vs 4%) were reported more often in the hyponatremia group than in patients with normal levels., Significance: People with COIH had a 7-fold increased risk of developing adverse effects during treatment. Clinicians should consider ascertainment of sodium levels in patients taking CBZ and OXC and act upon findings., (© 2021 The Authors. Epilepsia published by Wiley Periodicals LLC on behalf of International League Against Epilepsy.) more...

Published
2021
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2. Carbamazepine- and oxcarbazepine-induced hyponatremia in people with epilepsy.

Author

Berghuis B, van der Palen J, de Haan GJ, Lindhout D, Koeleman BPC, and Sander JW

Subjects
Adult, Anticonvulsants therapeutic use, Carbamazepine therapeutic use, Cohort Studies, Drug Therapy, Combination adverse effects, Female, Humans, Hyponatremia blood, Male, Middle Aged, Oxcarbazepine, Risk Factors, Sex Factors, Sodium blood, Anticonvulsants adverse effects, Carbamazepine adverse effects, Carbamazepine analogs & derivatives, Epilepsy drug therapy, Hyponatremia chemically induced
Abstract

Objective: To ascertain possible determinants of carbamazepine (CBZ)- and oxcarbazepine (OXC)-induced hyponatremia in a large cohort of people with epilepsy., Methods: We collected data on serum sodium levels in people with epilepsy who were attending a tertiary epilepsy center while on treatment with CBZ or OXC. We defined hyponatremia as Na+ ≤134 mEq/L and severe hyponatremia as Na+ ≤128 mEq/L., Results: We identified 1,782 people who had used CBZ (n = 1,424) or OXC (n = 358), of whom 50 were treated with both drugs. Data on sodium level measurements were available in 1,132 on CBZ and in 289 on OXC. Hyponatremia occurred in 26% of those taking CBZ and 46% of those taking OXC. This was severe in 7% in the CBZ group and 22% in the OXC group. Hyponatremia was symptomatic in 48% and led to admissions in 3%. Age over 40 years, high serum levels of CBZ and OXC, and concomitant use of other antiepileptic drugs were the main risk factors for hyponatremia in both treatment groups. Female patients on OXC were at a higher risk than male patients of hyponatremia. The risk of hyponatremia on CBZ was significantly associated with the risk of hyponatremia on OXC within a subgroup that used both drugs consecutively., Significance: Hyponatremia is a common problem in people taking CBZ or OXC. Regular ascertainment of sodium levels in those taking either drug is recommended and results should be acted on., (Wiley Periodicals, Inc. © 2017 International League Against Epilepsy.) more...

Published
2017
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3. Epidemiology, pathophysiology and putative genetic basis of carbamazepine- and oxcarbazepine-induced hyponatremia.

Author

Berghuis B, de Haan GJ, van den Broek MP, Sander JW, Lindhout D, and Koeleman BP

Subjects
Animals, Humans, Hyponatremia epidemiology, Hyponatremia genetics, Hyponatremia physiopathology, Oxcarbazepine, Pharmacogenetics, Anticonvulsants adverse effects, Carbamazepine adverse effects, Carbamazepine analogs & derivatives, Hyponatremia chemically induced
Abstract

The use of carbamazepine (CBZ) and oxcarbazepine (OXC) as first-line antiepileptic drugs in the treatment of focal epilepsy is limited by hyponatremia, a known adverse effect. Hyponatremia occurs in up to half of people taking CBZ or OXC and, although often assumed to be asymptomatic, it can lead to symptoms ranging from unsteadiness and mild confusion to seizures and coma. Hyponatremia is probably due to the antidiuretic properties of CBZ and OXC that are, at least partly, explained by stimulation of the vasopressin 2 receptor/aquaporin 2 pathway. No known genetic risk variants for CBZ- and OXC-induced hyponatremia exist, but likely candidate genes are part of the vasopressin water reabsorption pathway., (© 2016 EAN.) more...

Published
2016
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4. Comparative effectiveness of antiepileptic drugs in juvenile myoclonic epilepsy

Author

Silvennoinen K., de Lange N., Zagaglia S., Balestrini S., Androsova G., Wassenaar M., Auce P., Avbersek A., Becker F., Berghuis B., Campbell E., Coppola A., Francis B., Wolking S., Cavalleri G. L., Craig J., Delanty N., Johnson M. R., Koeleman B. P. C., Kunz W. S., Lerche H., Marson A. G., O'Brien T. J., Sander J. W., Sills G. J., Striano P., Zara F., van der Palen J., Krause R., Depondt C., Sisodiya S. M., Brodie M. J., Chinthapalli K., de Haan G. -J., Doherty C. P., Heavin S., McCormack M., Petrovski S., Sargsyan N., Slattery L., Willis J., National Institute for Health Research, Silvennoinen, K., de Lange, N., Zagaglia, S., Balestrini, S., Androsova, G., Wassenaar, M., Auce, P., Avbersek, A., Becker, F., Berghuis, B., Campbell, E., Coppola, A., Francis, B., Wolking, S., Cavalleri, G. L., Craig, J., Delanty, N., Johnson, M. R., Koeleman, B. P. C., Kunz, W. S., Lerche, H., Marson, A. G., O'Brien, T. J., Sander, J. W., Sills, G. J., Striano, P., Zara, F., van der Palen, J., Krause, R., Depondt, C., Sisodiya, S. M., Brodie, M. J., Chinthapalli, K., de Haan, G. -J., Doherty, C. P., Heavin, S., Mccormack, M., Petrovski, S., Sargsyan, N., Slattery, L., and Willis, J. more...

Subjects
Topiramate, Pediatrics, medicine.medical_specialty, Neurology [D14] [Human health sciences], seizure, adverse drug reaction, Clinical Neurology, Lamotrigine, lcsh:RC346-429, 03 medical and health sciences, Epilepsy, 0302 clinical medicine, Journal Article, medicine, 030212 general & internal medicine, EpiPGX Consortium, tolerability, lcsh:Neurology. Diseases of the nervous system, seizures, adverse drug reactions, Neurologie [D14] [Sciences de la santé humaine], business.industry, Weight change, Généralités, Carbamazepine, medicine.disease, 3. Good health, valproate, Neurology, Tolerability, Full‐length Original Research, Neurology (clinical), Levetiracetam, Juvenile myoclonic epilepsy, business, 030217 neurology & neurosurgery, medicine.drug
Abstract

Objective: To study the effectiveness and tolerability of antiepileptic drugs (AEDs) commonly used in juvenile myoclonic epilepsy (JME). Methods: People with JME were identified from a large database of individuals with epilepsy, which includes detailed retrospective information on AED use. We assessed secular changes in AED use and calculated rates of response (12-month seizure freedom) and adverse drug reactions (ADRs) for the five most common AEDs. Retention was modeled with a Cox proportional hazards model. We compared valproate use between males and females. Results: We included 305 people with 688 AED trials of valproate, lamotrigine, levetiracetam, carbamazepine, and topiramate. Valproate and carbamazepine were most often prescribed as the first AED. The response rate to valproate was highest among the five AEDs (42.7%), and significantly higher than response rates for lamotrigine, carbamazepine, and topiramate; the difference to the response rate to levetiracetam (37.1%) was not significant. The rates of ADRs were highest for topiramate (45.5%) and valproate (37.5%). Commonest ADRs included weight change, lethargy, and tremor. In the Cox proportional hazards model, later start year (1.10 [1.08-1.13], P, SCOPUS: ar.j, info:eu-repo/semantics/published more...

Published
2019

5. A genome-wide association study of sodium levels and drug metabolism in an epilepsy cohort treated with carbamazepine and oxcarbazepine

Author

Berghuis, B., Stapleton, C., Sonsma, A. C. M., Hulst, J., de Haan, G. -J., Lindhout, D., Demurtas, R., Krause, R., Depondt, C., Kunz, W. S., Zara, F., Striano, P., Craig, J., Auce, P., Marson, A. G., Stefansson, H., O'Brien, T. J., Johnson, M. R., Sills, G. J., Wolking, S., Lerche, H., Sisodiya, S. M., Sander, J. W., Cavalleri, G. L., Koeleman, B. P. C., Mccormack, M., Avbersek, A., Leu, C., Heggeli, K., Willis, J., Speed, D., Sargsyan, N., Chinthapalli, K., Borghei, M., Coppola, A., Gambardella, A., Becker, F., Rau, S., Hengsbach, C., Weber, Y. G., Delanty, N., Campbell, E., Gudmundsson, L. J., Ingason, A., Stefansson, K., Schneider, R., Balling, R., Francis, B., Jorgensen, A., Morris, A., Langley, S., Srivastava, P., Brodie, M., Todaro, M., Petrovski, S., Hutton, J., Zimprich, F., Krenn, M., Muhle, H., Martin Klein, K., Moller, R., Nikanorova, M., Weckhuysen, S., Rener-Primec, Z., Berghuis, Bianca, Stapleton, Caragh, Sonsma, Anja C. M., Hulst, Janic, de Haan, Gerrit-Jan, Lindhout, Dick, Demurtas, Rita, Krause, Roland, Depondt, Chantal, Kunz, Wolfram S., Zara, Federico, Striano, Pasquale, Craig, John, Auce, Paul, Marson, Anthony G., Stefansson, Hreinn, O'Brien, Terence J., Johnson, Michael R., Sills, Graeme J., Wolking, Stefan, Lerche, Holger, Sisodiya, Sanjay M., Sander, Josemir W., Cavalleri, Gianpiero L., Koeleman, Bobby P. C., Mccormack, Mark, Weckhuysen, Sarah, EpiPGX Consortium, Imperial College Healthcare NHS Trust- BRC Funding, and Commission of the European Communities more...

Subjects
medicine.medical_specialty, hyponatremia, Clinical Neurology, Gastroenterology, 03 medical and health sciences, Epilepsy, 0302 clinical medicine, adverse effects, antiepileptic drugs, EpiPGX Consortium, GWAS, antiepileptic drug, Internal medicine, adverse effect, medicine, Oxcarbazepine, Adverse effect, 030304 developmental biology, 0303 health sciences, business.industry, Généralités, Carbamazepine, medicine.disease, 3. Good health, Neurology, Cohort, Full‐length Original Research, Phenobarbital, Human medicine, Neurology (clinical), Hyponatremia, business, 030217 neurology & neurosurgery, Drug metabolism, medicine.drug
Abstract

Objective: To ascertain the clinical and genetic factors contributing to carbamazepine- and oxcarbazepine-induced hyponatremia (COIH), and to carbamazepine (CBZ) metabolism, in a retrospectively collected, cross-sectional cohort of people with epilepsy. Methods: We collected data on serum sodium levels and antiepileptic drug levels in people with epilepsy attending a tertiary epilepsy center while on treatment with CBZ or OXC. We defined hyponatremia as Na+ ≤134 mEq/L. We estimated the CBZ metabolic ratio defined as the log transformation of the ratio of metabolite CBZ-diol to unchanged drug precursor substrate as measured in serum. Results: Clinical and genetic data relating to carbamazepine and oxcarbazepine trials were collected in 1141 patients. We did not observe any genome-wide significant associations with sodium level in a linear trend or hyponatremia as a dichotomous trait. Age, sex, number of comedications, phenytoin use, phenobarbital use, and sodium valproate use were significant predictors of CBZ metabolic ratio. No genome-wide significant associations with CBZ metabolic ratio were found. Significance: Although we did not detect a genetic predictor of hyponatremia or CBZ metabolism in our cohort, our findings suggest that the determinants of CBZ metabolism are multifactorial., SCOPUS: ar.j, info:eu-repo/semantics/published more...

Published
2019

6. Comparative effectiveness of antiepileptic drugs in patients with mesial temporal lobe epilepsy with hippocampal sclerosis

Author

Androsova, G., Krause, R., Borghei, M., Wassenaar, M., Auce, P., Avbersek, A., Becker, F., Berghuis, B., Campbell, E., Coppola, A., Francis, B., Wolking, S., Cavalleri, G. L., Craig, J., Delanty, N., Koeleman, B. P. C., Kunz, W. S., Lerche, H., Marson, A. G., Sander, J. W., Sills, G. J., Striano, P., Zara, F., Sisodiya, S. M., Depondt, C., Brodie, M. J., Chinthapalli, K., de Haan, G. -J., Doherty, C., Gudmundsson, L. J., Heavin, S., Ingason, A., Johnson, M., Kennedy, C., Krenn, M., McCormack, M., O'Brien, T. J., Pandolfo, M., Pataraia, E., Petrovski, S., Rau, S., Sargsyan, N., Slattery, L., Stefánsson, K., Stern, W., Tostevin, A., Willis, J., Zimprich, F., Androsova, G., Krause, R., Borghei, M., Wassenaar, M., Auce, P., Avbersek, A., Becker, F., Berghuis, B., Campbell, E., Coppola, A., Francis, B., Wolking, S., Cavalleri, G. L., Craig, J., Delanty, N., Koeleman, B. P. C., Kunz, W. S., Lerche, H., Marson, A. G., Sander, J. W., Sills, G. J., Striano, P., Zara, F., Sisodiya, S. M., Depondt, C., Brodie, M. J., Chinthapalli, K., de Haan, G. -J., Doherty, C., Gudmundsson, L. J., Heavin, S., Ingason, A., Johnson, M., Kennedy, C., Krenn, M., Mccormack, M., O'Brien, T. J., Pandolfo, M., Pataraia, E., Petrovski, S., Rau, S., Sargsyan, N., Slattery, L., Stefánsson, K., Stern, W., Tostevin, A., Willis, J., Zimprich, F., European Commission. Grant Number: 279062 [sponsor], Framework of the EU-funded FP7 research program BioCog [sponsor], Department of Health's NIHR Biomedical Research Centre's funding scheme [sponsor], Christelijke Vereniging voor de Verpleging van Lijders aan Epilepsie [sponsor], University of Liverpool [sponsor], Italian League Against Epilepsy (LICE) [sponsor], German Society for Epileptology [sponsor], Foundation no epilep [sponsor], Dr. Marvin Weil Epilepsy Research Fund [sponsor], Italian Ministry of Health [sponsor], European Community Sixth [sponsor], Telethon Foundation [sponsor], and Italian League Against Epilepsy [sponsor] more...

Subjects
Male, 0301 basic medicine, Cyclohexanecarboxylic Acids, Databases, Factual, efficacy, drug response, Pregabalin, Hippocampus, Benzodiazepines, Epilepsy, 0302 clinical medicine, seizure freedom, Amines, Oxcarbazepine, Multidisciplinary, general & others [D99] [Human health sciences], gamma-Aminobutyric Acid, adverse drug reactions, Triazines, Middle Aged, Seizure freedom, 3. Good health, Carbamazepine, Treatment Outcome, Retention, Neurology, Tolerability, Anesthesia, Vertigo, Anticonvulsants, Female, Gabapentin, medicine.drug, Adult, Lethargy, retention, medicine.medical_specialty, Multidisciplinaire, généralités & autres [D99] [Sciences de la santé humaine], Efficacy, Adolescent, Drug response, Vision Disorders, Adverse drug reactions, Fructose, Lamotrigine, Dizziness, Vigabatrin, Young Adult, 03 medical and health sciences, Topiramate, Internal medicine, Diplopia, medicine, Humans, Aged, Retrospective Studies, Hippocampal sclerosis, Sclerosis, business.industry, Valproic Acid, medicine.disease, 030104 developmental biology, Epilepsy, Temporal Lobe, Epilepsy syndromes, Clobazam, Ataxia, Neurology (clinical), business, 030217 neurology & neurosurgery
Abstract

SummaryObjective Mesial temporal lobe epilepsy with hippocampal sclerosis (MTLE-HS) is a common epilepsy syndrome that is often poorly controlled by antiepileptic drug (AED) treatment. Comparative AED effectiveness studies in this condition are lacking. We report retention, efficacy, and tolerability in a cohort of patients with MTLE-HS. Methods Clinical data were collected from a European database of patients with epilepsy. We estimated retention, 12-month seizure freedom, and adverse drug reaction (ADR) rates for the 10 most commonly used AEDs in patients with MTLE-HS. Results Seven hundred sixty-seven patients with a total of 3,249 AED trials were included. The highest 12-month retention rates were observed with carbamazepine (85.9%), valproate (85%), and clobazam (79%). Twelve-month seizure freedom rates varied from 1.2% for gabapentin and vigabatrin to 11% for carbamazepine. Response rates were highest for AEDs that were prescribed as initial treatment and lowest for AEDs that were used in a third or higher instance. ADRs were reported in 47.6% of patients, with the highest rates observed with oxcarbazepine (35.7%), topiramate (30.9%), and pregabalin (27.4%), and the lowest rates with clobazam (6.5%), gabapentin (8.9%), and lamotrigine (16.6%). The most commonly reported ADRs were lethargy and drowsiness, dizziness, vertigo and ataxia, and blurred vision and diplopia. Significance Our results did not demonstrate any clear advantage of newer versus older AEDs. Our results provide useful insights into AED retention, efficacy, and ADR rates in patients with MTLE-HS. more...

Published
2017