Systematic Adverse Drug Reaction Monitoring of Patients Under Newer Antiepileptic Drugs Using Routine Clinical Data of Inpatients

Hilgers, Annika; Schaefer, Marion

doi:10.1007/s40801-016-0077-2

Cited by 13 publications

(10 citation statements)

References 46 publications

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“…In epilepsy treatment, mitigation of ADRs is a critical target for all patients. This study’s results showed that 56.7% of patients experienced ADRs when undergoing AED therapy, a result which is similar to that of a study investigating the ADRs of newer AEDs in Germany, where 56.6% of patients were reported with ADRs [ 19 ]. Findings from the literature suggest that newer AEDs may have better tolerability and safety than older generation medications, i.e., carbamazepine, phenytoin, and valproic acid [ 20 ].…”

Section: Discussionsupporting

confidence: 85%

“…Despite this, the similarity in prevalence between these two sets of ADR could possibly have resulted from the interventions of the clinical pharmacists in our study, which aimed to minimize the adverse effects of AEDs. Furthermore, the question of whether monotherapy or polytherapy is associated with more ADRs is still controversial [ 19 ]. Although in this study, the two types of therapy did not differ significantly in terms of adverse reactions, evidence from previous research indicates a higher risk of side effects in patients on polymedication regimens [ 16 , 21 ].…”

Section: Discussionmentioning

confidence: 99%

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Role of clinical pharmacists in epilepsy management at a general hospital in Vietnam: a before-and-after study

Pham

Tran

Nguyen

et al. 2021

J of Pharm Policy and Pract

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Background Clinical pharmacists have an important role in inter-professional healthcare collaboration for epilepsy management. However, the pharmacy practices of managing epilepsy are still limited in Vietnam, deterring pharmacists from routine adjustments of antiepileptic drugs, which could decrease the patients’ quality of life. This study aimed to assess the effectiveness of pharmacist interventions in epilepsy treatment at a Vietnamese general hospital. Methods A before-and-after study was conducted from January 2016 to December 2018. All patients with a diagnosis of epilepsy and being treated at the investigated hospital were recruited and screened for eligibility and exclusion criteria. The primary outcome was the proportion of patients in good control of their epilepsy (with two seizures or less in a year). The secondary outcome was the number of patients maintaining optimized concentrations within the therapeutic range of carbamazepine (4–12 mg/L), phenytoin (10–20 mg/L), or valproic acid (50–100 mg/L). Collected data were analyzed using two proportions Z-test or Chi-square test. Results A total of 141 participants were enrolled in the study. While most patients were given lower prescribed daily doses than the recommendations from the World Health Organization, over 56% of the participants still experienced adverse drug effects. More than half of the patients received at least one pharmacists’ intervention, which increased by 25.0% the effectiveness of the therapy (p < 0.001) and by 14.6% the number of patients with optimized drug concentrations (p = 0.018). Conclusion Epilepsy management requires a multiple-stepped and comprehensive approach, with a focus on the health and safety of the patients. As part of the healthcare team, pharmacists need to engage at every stage to monitor the patient’s response and determine the most effective treatment with the fewest adverse drug reactions. Trial registration ClinicalTrials.gov, NCT04967326. Registered July 19, 2021—Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT04967326

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Section: Discussionsupporting

confidence: 85%

Section: Discussionmentioning

confidence: 99%

Role of clinical pharmacists in epilepsy management at a general hospital in Vietnam: a before-and-after study

Pham

Tran

Nguyen

et al. 2021

J of Pharm Policy and Pract

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“…Objectivity was based on all doses, FDA-recommended daily maintenance doses, and maximum and minimum ASM doses based on prescribing information or the network studies. Subjective dosing due to unclear language in the prescribing information (e.g., brivaracetam) or due to dosing recommendations not in alignment with those used in clinical trials or currently used in clinical practice (e.g., lacosamide [23][24][25]47] and topiramate) were also captured in the ITC [29][30][31]42,47].…”

Section: Discussionmentioning

confidence: 99%

Indirect treatment comparison of cenobamate to other ASMs for the treatment of uncontrolled focal seizures

Privitera

Richy

Schabert

2022

Epilepsy & Behavior

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Objective: The efficacy and safety of cenobamate relative to other antiseizure medications (ASMs) has not been evaluated. An indirect treatment comparison (network meta-analysis) was performed to determine if adjunctive cenobamate increases the odds ratio (OR) for 50% responder rate or for withdrawals due to treatment-emergent adverse events (TEAEs) leading to ASM discontinuation versus adjunctive therapy with other ASMs. Methods: A systematic literature review was conducted to identify randomized, double-blind, placebocontrolled trials (maintenance phase 12 weeks) assessing adjunctive ASMs in adults with uncontrolled focal seizures. Cenobamate was compared to a group of seven other ASMs, and to subgroups of branded (brivaracetam, eslicarbazepine acetate, lacosamide, and perampanel) and older (lamotrigine, levetiracetam, and topiramate) ASMs at FDA-recommended daily maintenance doses (FDA-RDMD), at all doses, and at maximum and minimum daily doses. Statistical significance was set at p < 0.05. Results: Twenty-one studies were eligible for analysis. The placebo-adjusted 50% responder rate for FDA-RDMD of cenobamate was superior (OR 4.200; 95% CI 2.279, 7.742) to FDA-RDMD of all seven assessed (OR 2.202 95% CI 1.915, 2.532; p = 0.044) and branded ASMs (OR 2.148; 95% CI 1.849, 2.494; p = 0.037). There was no significant difference for 50% responder rate between FDA-RDMD of cenobamate and FDA-RDMD of older ASMs (OR 2.617; 95% CI 1.767, 3.878; p = 0.202). No significant differences were identified for 50% responder rate when comparing all doses and maximum/minimum doses of cenobamate to all seven, branded, and older ASMs. Cenobamate demonstrated comparable TEAE withdrawal rates to all seven ASMs, branded ASMs, and older ASMs across each of the four dose ranges (all p > 0.05). Significance: Patients receiving FDA-RDMD of cenobamate were more likely to have 50% seizure reduction compared with FDA-RDMD of the seven assessed ASMs and branded ASMs, without an increase in treatment discontinuation due to TEAEs.

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“…9 However, other studies have reported lower and a higher incidence rate of ADRs to AEDs compared to our study. [6][7][8][10][11][12]17,18 The reasons for higher incidence of reported ADRs than Mathur S et al could be due to the presence of study investigator/pharmacist during the patient interaction and history taking especially in outpatient settings. 6 In addition, our study has documented all types of ADRs including minor and well-documented ones.…”

Section: Discussionmentioning

confidence: 99%

“…These studies have identified ADRs in 4.67%-31% in patients receiving different AEDs. [8][9][10][11][12] There is a scarce in the published data regarding the incidence and pattern of ADRs to different AEDs in the local population. With this background, the main aim of the study was to identify and evaluate the ADRs associated with different antiepileptic drugs based on preventability, predictability and severity.…”

Section: Introductionmentioning

confidence: 99%

Intensive Monitoring of Adverse Drug Reactions to Antiepileptic Drugs in Neurology Department of a Secondary Care Hospital in U.A.E

Alkhalil¹,

Sridhar²,

Rabbani³

et al. 2019

JYP

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Objective:The general objective of this study was to identify and evaluate adverse drug reactions (ADRs) associated with antiepileptic drugs. Methodology: This was a cross-sectional study, conducted in the neurology department of a secondary care hospital. All the patients meeting the inclusion criteria were identified and evaluated. Data were collected from the electronic medical records and was entered into a data collection. All ADRs identified and reported were evaluated for causality, severity, preventability and predictability using different standard scales. Results: A total of 24 ADRs was detected, documented, evaluated and reported during the study period. The incidence was found to be 10%. Assessment of severity of the suspected ADRs revealed that 12% of suspected ADRs were mild level 1 (54.2%) and level 2 (41.7%). Causality assessment by WHO assessment scale reveals that majority of ADRs were considered as a probable 15 (62.5%). Higher incidence of ADRs was documented in females (58.8%). Central and peripheral nervous system was most commonly affected 09 (37.5%) organ system. Sodium valproate was the most common drug mostly associated with ADRs. All 24 (100%) of ADRs were definitely preventable. None of the demographic, disease or treatment-related factors were significant (p>0.05) predictors of ADRs. Conclusion: The findings of our study highlights the importance of regular monitoring and reporting of ADRs in the study setting. However, the study necessitates the importance of multicenter studies to further explore and evaluate the pattern of ADRs to different AEDs in the multiethnic population of U.A.E.This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as the author is credited and the new creations are licensed under the identical terms.

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Systematic Adverse Drug Reaction Monitoring of Patients Under Newer Antiepileptic Drugs Using Routine Clinical Data of Inpatients

Cited by 13 publications

References 46 publications

Role of clinical pharmacists in epilepsy management at a general hospital in Vietnam: a before-and-after study

Role of clinical pharmacists in epilepsy management at a general hospital in Vietnam: a before-and-after study

Indirect treatment comparison of cenobamate to other ASMs for the treatment of uncontrolled focal seizures

Intensive Monitoring of Adverse Drug Reactions to Antiepileptic Drugs in Neurology Department of a Secondary Care Hospital in U.A.E

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