Oxcarbazepine oral suspension in young pediatric patients with partial seizures and/or generalized tonic–clonic seizures in routine clinical practice in China: a prospective observational study

Qin, Jiong; Wang, Yi; Huang, Xinfang; Zhang, Yuqin; Fang, Fang; Chen, Yinbo; Zeng, Lin; Deng, Yanchun; Yin, Fei; Jiang, Li; Wu, Ye; Hu, Xiangshu

doi:10.1007/s12519-017-0114-6

Cited by 5 publications

(5 citation statements)

References 34 publications

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“…We, therefore, set the highest dose of LEV as around 40 mg/Kg/d in this study aiming to avoid the potential side effects as far as possible. In line with a study that enrolled children aged 2–5 years ( 29 ), the most common AEs by OXC were rash (3.1%) and somnolence (2%). All AEs were of mild severity and were transient; the exception was one patient who withdrew from the OXC group due to medication-induced hypersensitivity syndrome.…”

Section: Discussionsupporting

confidence: 70%

Effectiveness and Safety of Oxcarbazepine vs. Levetiracetam as Monotherapy for Infantile Focal Epilepsy: A Longitudinal Cohort Study

et al. 2022

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ObjectiveThis study aimed to compare the effectiveness and safety of oxcarbazepine (OXC) vs. levetiracetam (LEV) for treating infantile focal epilepsy in a longitudinal cohort study.MethodsWe enrolled 187 consecutive patients aged 2–24 months who received OXC or LEV as initial monotherapy; 161 patients completed the study. The longitudinal analysis involved anti-seizure medication (ASM) responsiveness, safety, the establishment of epilepsy syndrome, and etiology over a median follow-up of 2 years (interquartile range [IQR] 1.6–2.4). The relative efficacy and retention rates of OXC vs. LEV were evaluated using generalized linear regression models and the Cox proportional hazards model.ResultsThe 161 patients who completed the study had comparable baseline demographics and clinical variables between the OXC group (n = 83) and LEV group (n = 78). Overall, the mean age at onset was 6 months (IQR 4.3–9). The most common epilepsy syndrome was self-limited familial/non-familial infantile epilepsy (54.7%). Epilepsy was related to genetic and unknown causes in 34.2 and 52.2% of the patients, respectively. OXC achieved significantly higher responses than LEV for seizure freedom (risk ratio [RR] = 1.71, 95% confidence interval [CI] = 1.28–2.73, P < 0.001) and 12-month retention rate after onset (hazard ratio [HR] = 1.84, 95% CI = 1.15–2.95, P = 0.007). Moreover, OXC showed more obvious effects for patients aged < 1 year diagnosed with self-limited familial/non-familial infantile epilepsy and non-syndromic epilepsy with genetic or unknown causes. The adverse events related to both OXC and LEV were well-tolerated.SignificanceOXC could be an alternative to LEV for treating infantile focal epilepsy. OXC monotherapy can be considered first-line treatment for patients aged <12 months and those with epilepsy without developmental and epileptic encephalopathy.

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Section: Discussionsupporting

confidence: 70%

Effectiveness and Safety of Oxcarbazepine vs. Levetiracetam as Monotherapy for Infantile Focal Epilepsy: A Longitudinal Cohort Study

et al. 2022

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“…Use of CBZ and OXC has previously been associated with relatively high rates of rash (3%‐19% and 3%‐8%, respectively). In addition, an analysis of AED‐induced SCARs found that CBZ was one of the major causative AEDs for this type of reaction .…”

Section: Discussionmentioning

confidence: 99%

“…[6][7][8][9][10][11] ESL is a dibenzazepine carboxamide derivative. Relatively high rates of rash have previously been observed with phenytoin and lamotrigine (LTG), and other dibenzazepine carboxamides such as carbamazepine (CBZ) and oxcarbazepine (OXC), 1,2,[12][13][14][15][16][17][18][19] and so it is relevant to examine to what extent allergic reactions also occur with ESL, and whether there may be any identifiable risk factors.…”

Section: Introductionmentioning

confidence: 99%

Analysis of cutaneous allergic reactions in clinical trials of eslicarbazepine acetate

Rogin¹,

Resnick

Strom

et al. 2020

Acta Neurol Scand

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Objectives To evaluate cutaneous allergic reactions in clinical trials of adjunctive eslicarbazepine acetate (ESL) for focal seizures. Materials and methods Data were analyzed from three phase III randomized, double‐blind, placebo‐controlled studies of adjunctive ESL in adults (placebo, n = 426; ESL, n = 1021) and two randomized, double‐blind, placebo‐controlled studies (and open‐label extensions [OLEs]) of adjunctive ESL in children aged 4‐17 years (placebo, n = 160; ESL, n = 202; OLE, n = 337). Results Adult studies: Rash (ESL 1.9%, placebo 0.9%) and pruritus (ESL 1.2%, placebo 0.9%) were the most frequent rash‐related treatment‐emergent adverse events (TEAEs). Most rash‐related TEAEs were mild or moderate in severity. Incidence of rash increased with increasing ESL dose, but was not higher for patients who initiated treatment with higher ESL doses. Pediatric studies: Allergic dermatitis (ESL 3.0%, placebo 0) and rash (controlled studies: ESL 1.0%, placebo 1.3%; OLE periods: ESL ≤1.2%) were the most frequent rash‐related TEAEs. There was one case of DRESS in the ESL group. Most rash‐related TEAEs were mild or moderate in severity and judged as not related to treatment with ESL. Conclusions Serious skin rashes were rare during adult and pediatric clinical trials of ESL. Although the incidence of rash with ESL was low, it is important for patients/caregivers to be made aware of the potential signs and symptoms associated with serious skin rashes.

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“…In terms of outcomes, there are favorable real-world evidence efficacy data in China for both CBZ and OXC in focal epilepsy [47][48][49]. In addition, OXC oral suspension is used in Chinese children for focal and generalized tonic-clonic seizures with substantial evidence for efficacy and safety [50,51] (Table 4). However, while OXC is approved in China for generalized onset tonic-clonic seizures in children it should be noted that it is not the case in some other countries including the US [50].…”

Section: Asiamentioning

confidence: 99%

Current role of carbamazepine and oxcarbazepine in the management of epilepsy

Beydoun

Dupont

Zhou

et al. 2020

Seizure

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Oxcarbazepine oral suspension in young pediatric patients with partial seizures and/or generalized tonic–clonic seizures in routine clinical practice in China: a prospective observational study

Abstract: This study, reporting the real-world data, further confirms the efficacy and good safety profile of OXC oral suspension in Chinese pediatric patients aged 2-5 years with PS and/or GTCS.

Cited by 5 publications

References 34 publications

Effectiveness and Safety of Oxcarbazepine vs. Levetiracetam as Monotherapy for Infantile Focal Epilepsy: A Longitudinal Cohort Study

Effectiveness and Safety of Oxcarbazepine vs. Levetiracetam as Monotherapy for Infantile Focal Epilepsy: A Longitudinal Cohort Study

Analysis of cutaneous allergic reactions in clinical trials of eslicarbazepine acetate

Current role of carbamazepine and oxcarbazepine in the management of epilepsy

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