Adverse Event Profiles of Antiseizure Medications and the Impact of Coadministration on Drug Tolerability in Adults with Epilepsy

Willems, Laurent M.; van der Goten, Milena; von Podewils, Felix; Knake, Susanne; Kovac, Stjepana; Zöllner, Johann Philipp; Rosenow, Felix; Strzelczyk, Adam

doi:10.1007/s40263-023-01013-8

Cited by 10 publications

(6 citation statements)

References 95 publications

(84 reference statements)

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“…Besides, differing assessment criteria and definitions may also play a role. Nevertheless, these results suggest tolerability issues of valproate treatment in SE patients, as shown recently in epilepsy patients [ 17 ].…”

Section: Discussionmentioning

confidence: 59%

“…To our best knowledge, this is the first study estimating the acute VIE incidence in SE patients. Like patients with epilepsy [ 17 ], valproate seems not so well tolerated in patients with SE. In this relatively small sample, VIE seems relatively frequent (10%), often occurred without hyperammonemia, and was possibly associated with preexisting liver disease.…”

Section: Discussionmentioning

confidence: 99%

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Acute Valproate-Induced Encephalopathy in Status Epilepticus: A Registry-Based Assessment

et al. 2023

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Background Valproate-induced encephalopathy (VIE) affects between 0.1% and 2.5% of patients under long-term epilepsy treatment. Its frequency and characteristics in adults with status epilepticus (SE) is, however, unknown. Objective The aim of this study was to characterize the frequency and the clinico-biological characteristics of VIE in adult SE patients. Methods We reviewed all patients included in our institutional SE registry who were treated for an SE episode between November 2021 and February 2023 and identified 39 patients who received valproate for their SE treatment. Acute VIE was defined by worsening of consciousness having led to the discontinuation of valproate, and improvement of consciousness within 96 hours after discontinuation of valproate during acute hospital treatment. Results Patients had a mean valproate intravenous loading dose of 34.5 mg/kg and a mean maintenance dose of 15.3 mg/ kg/d (1078 mg/d). Four out of 29 patients with measured ammonium had hyperammonemia. We identified four (10%) patients fulfilling acute VIE criteria. Median time from administration of valproate to the occurrence of VIE, and to resolution of VIE after cessation of valproate treatment, was 2 days for each. Three of the four VIE patients had no associated hyperammonemia. Patients who developed VIE more frequently had a history of liver disease (p = 0.023), and tended to be younger, but other clinical variables did not differ significantly from patients without VIE, including valproate loading or maintenance doses, SE cause, duration or severity, other concomitant antiseizure medications (none received topiramate, phenobarbital, or primidone). Conclusion Pending larger studies, VIE in SE seems relatively frequent and difficult to foresee; clinical alertness to symptoms is mandatory, even without hyperammonemia, and valproate withdrawal should be considered in suspected cases.

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Section: Discussionmentioning

confidence: 59%

Section: Discussionmentioning

confidence: 99%

Acute Valproate-Induced Encephalopathy in Status Epilepticus: A Registry-Based Assessment

et al. 2023

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“…A retrospective analysis of data from a large German multicenter study showed synaptic vesicle glycoprotein 2A modulators have a favorable adverse event profile, with BRV showing fewer psychobehavioral adverse events than LEV [ 28 ]. In EXPERIENCE, the incidences of psychiatric, cognitive, and behavioral TEAEs were similar in patients with psychiatric comorbidity who switched from LEV to BRV compared with patients who switched from other ASMs to BRV; this finding was also observed in patients without psychiatric comorbidity who switched from LEV to BRV compared with patients who switched from other ASMs to BRV.…”

Section: Discussionmentioning

confidence: 99%

Effectiveness and tolerability of brivaracetam in patients with epilepsy stratified by comorbidities and etiology in the real world: 12-month subgroup data from the international EXPERIENCE pooled analysis

Szaflarski,

Besson,

D’Souza

et al. 2024

J Neurol

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Objective To assess the effectiveness and tolerability of brivaracetam (BRV) in adults with epilepsy by specific comorbidities and epilepsy etiologies. Methods EXPERIENCE/EPD332 was a pooled analysis of individual patient records from several non-interventional studies of patients with epilepsy initiating BRV in clinical practice. Outcomes included ≥ 50% reduction from baseline in seizure frequency, seizure freedom (no seizures within prior 3 months), continuous seizure freedom (no seizures since baseline), BRV discontinuation, and treatment-emergent adverse events (TEAEs) at 3, 6, and 12 months. Analyses were performed for all adult patients (≥ 16 years of age) and stratified by comorbidity and by etiology at baseline (patients with cognitive/learning disability [CLD], psychiatric comorbidity, post-stroke epilepsy, brain tumor−related epilepsy [BTRE], and traumatic brain injury−related epilepsy [TBIE]). Results At 12 months, ≥ 50% seizure reduction was achieved in 35.6% (n = 264), 38.7% (n = 310), 41.7% (n = 24), 34.1% (n = 41), and 50.0% (n = 28) of patients with CLD, psychiatric comorbidity, post-stroke epilepsy, BTRE, and TBIE, respectively; and continuous seizure freedom was achieved in 5.7% (n = 318), 13.7% (n = 424), 29.4% (n = 34), 11.4% (n = 44), and 13.8% (n = 29), respectively. During the study follow-up, in patients with CLD, psychiatric comorbidity, post-stroke epilepsy, BTRE, and TBIE, 37.1% (n = 403), 30.7% (n = 605), 33.3% (n = 51), 39.7% (n = 68), and 27.1% (n = 49) of patients discontinued BRV, respectively; and TEAEs since prior visit at 12 months were reported in 11.3% (n = 283), 10.0% (n = 410), 16.7% (n = 36), 12.5% (n = 48), and 3.0% (n = 33), respectively. Conclusions BRV as prescribed in the real world is effective and well tolerated among patients with CLD, psychiatric comorbidity, post-stroke epilepsy, BTRE, and TBIE.

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“…The results of the LAEP, HADS-D, and NDDI-E scores overlapped, a recent mediation analysis revealed that patient-reported depression and ASM-related adverse events jointly mediated the association between ASMs and QoL [ 37 ]. Adverse events must be carefully evaluated, and the adverse events profile should always be taken into consideration when selecting an ASM [ 38 ]. The number of ASMs was not significantly correlated with QoL.…”

Section: Discussionmentioning

confidence: 99%

Determinants of quality of life in adults with epilepsy: a multicenter, cross-sectional study from Germany

Siebenbrodt

Willems

Podewils

et al. 2023

Neurol. Res. Pract.

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Background Assessment of quality of life (QoL) has become an important indicator for chronic neurological diseases. While these conditions often limit personal independence and autonomy, they are also associated with treatment-related problems and reduced life expectancy. Epilepsy has a tremendous impact on the QoL of patients and their families, which is often underestimated by practitioners. The aim of this work was to identify relevant factors affecting QoL in adults with epilepsy. Methods This cross-sectional, multicenter study was conducted at four specialized epilepsy centers in Germany. Patients diagnosed with epilepsy completed a standardized questionnaire focusing on QoL and aspects of healthcare in epilepsy. Univariate regression analyses and pairwise comparisons were performed to identify variables of decreased QoL represented by the overall Quality of Life in Epilepsy Inventory (QOLIE-31) score. The variables were then considered in a multivariate regression analysis after multicollinearity analysis. Results Complete datasets for the QOLIE-31 were available for 476 patients (279 [58.6%] female, 197 [41.4%] male, mean age 40.3 years [range 18–83 years]). Multivariate regression analysis revealed significant associations between low QoL and a high score on the Liverpool Adverse Events Profile (LAEP; beta=-0.28, p < 0.001), Hospital Anxiety and Depression Scale – depression subscale (HADS-D; beta=-0.27, p < 0.001), Neurological Disorders Depression Inventory in Epilepsy (NDDI-E; beta=-0.19, p < 0.001), revised Epilepsy Stigma Scale (beta=-0.09, p = 0.027), or Seizure Worry Scale (beta=-0.18, p < 0.001) and high seizure frequency (beta = 0.14, p < 0.001). Conclusion Epilepsy patients had reduced QoL, with a variety of associated factors. In addition to disease severity, as measured by seizure frequency, the patient’s tolerability of anti-seizure medications and the presence of depression, stigma, and worry about new seizures were strongly associated with poor QoL. Diagnosed comorbid depression was underrepresented in the cohort; therefore, therapeutic decisions should always consider individual psychobehavioral and disease-specific aspects. Signs of drug-related adverse events, depression, fear, or stigmatization should be actively sought to ensure that patients receive personalized and optimized treatment. Trial Registration German Clinical Trials Register (DRKS00022024; Universal Trial Number: U1111-1252-5331).

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Adverse Event Profiles of Antiseizure Medications and the Impact of Coadministration on Drug Tolerability in Adults with Epilepsy

Cited by 10 publications

References 95 publications

Acute Valproate-Induced Encephalopathy in Status Epilepticus: A Registry-Based Assessment

Acute Valproate-Induced Encephalopathy in Status Epilepticus: A Registry-Based Assessment

Effectiveness and tolerability of brivaracetam in patients with epilepsy stratified by comorbidities and etiology in the real world: 12-month subgroup data from the international EXPERIENCE pooled analysis

Determinants of quality of life in adults with epilepsy: a multicenter, cross-sectional study from Germany

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