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Audit of Use of Stiripentol in Adults with Dravet Syndrome

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Audit of Use of Stiripentol in Adults with Dravet Syndrome Accepted: 26 April 2016 DOI: 10.1111/ane.12611 ORIGINAL ARTICLE Audit of use of stiripentol in adults with Dravet syndrome S. Balestrini1,2,3 | S. M. Sisodiya1,2 1Department of Clinical and Experimental Epilepsy, NIHR University College London Objectives: There are very few data available in the literature on the use of Hospitals Biomedical Research Centre, UCL stiripentol in adults with Dravet syndrome (DS). DS cases are increasingly recog- Institute of Neurology, London, UK nized in adulthood, and more children with DS now survive to adulthood. The aim 2Epilepsy Society, Chalfont-St-Peter, Buckinghamshire, UK of the study was to document the effectiveness and tolerability of stiripentol in 3Neuroscience Department, Polytechnic adults with DS. University of Marche, Ancona, Italy Material and methods: We conducted an observational clinical audit in the epilepsy service of the National Hospital for Neurology and Neurosurgery, London (UK). Correspondence S. M. Sisodiya, Department of Clinical and Results: We included 13 adult subjects with DS (eight females, five males). The Experimental Epilepsy, UCL Institute of Neurology, Queen Square, London, UK. responder (defined as more than 50% reduction in all seizure types) rate was 3/13 Email: [email protected] (23%) at 36 months. The following other outcomes were reported: seizure exac- Source of Funding erbation (3/13, 23%), no change (3/13, 23%), less than 50% reduction in seizures Wellcome Trust and NIHR. (2/13, 15%), more than 50% reduction in generalized tonic- clonic seizures but no other seizure types (1/13, 8%), undefined response (1/13, 8%). The retention rate was 62% after 1 year and 31% after 5 years. Adverse effects were reported in 7/13 (54%): the most frequent were anorexia, weight loss, unsteadiness and tired- ness. Withdrawal due to adverse effects occurred in 3/13 (23%). Conclusions: Compared with previous studies on children with DS, our results show a lower responder rate and a similar tolerability profile. Stiripentol can be effective with a good tolerability profile. Our audit is small, but supports the use of stiripentol in adults with DS when first- line treatments are ineffective or not tolerated, in keeping with published guidelines. KEYWORDS antiepileptic drugs, epilepsy, seizures, stiripentol 1 | INTRODUCTION example, carbamazepine, oxcarbazepine and phenytoin, should usually Dravet syndrome (DS) is a severe genetic epileptic encephalopathy be avoided as they can aggravate both seizures and interictal EEG.9 with onset in infancy, often associated with drug- resistant epilepsy, Lamotrigine can also cause seizure exacerbation,10 although has been developmental slowing, cognitive impairment, occurrence of status reported to be beneficial in some cases.11 Effective treatment strate- epilepticus and elevated risk of early mortality.1–3 In most cases, the gies include valproic acid, clobazam, topiramate, levetiracetam, fenflu- cause is a mutation in the voltage- gated sodium channel type I al- ramine and bromides,12–14 or dietary therapies (ketogenic or modified pha subunit gene, SCN1A.4 The main challenges include seizure con- Atkins diet).15 There are ongoing studies on the use of cannabidiol in trol, prevention of status epilepticus and optimizing development of children with DS.16 Stiripentol was licensed under the European Med- cognitive function, where possible. The adult phenotype has been icine Agency Orphan Drug scheme in 2001 and is the only treatment described in a number of previous studies.2,5–8 Adjustment of treat- for which a randomized, placebo- controlled trial has been performed ment may be associated with improved seizure control, cognition and in children with DS,17 showing that significantly more children with DS quality of life, even into later adult life.2,6 Sodium channel blockers, for on stiripentol adjunctive therapy were seizure- free, or experienced at This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited. Acta Neurol Scand 2017; 135: 73–79 wileyonlinelibrary.com/journal/ane © 2016 The Authors. Acta Neurologica Scandinavica | 73 Published by John Wiley & Sons Ltd. 74 BALESTRINI AND SISODIYA least a 50% reduction in seizure frequency, compared with placebo. to the introduction of stiripentol. In five cases (29%), stiripentol was Very few data are available about the use of stiripentol in adults, with introduced in adolescence and continued into adulthood. The mean reports for fewer than fifteen DS cases older than 18 years,18–21 and age at introduction of stiripentol was 26 years (SD 12, range 12–47). twelve healthy adult volunteers.22 We conducted a clinical audit to In four subjects, it was introduced seven to ten years (median 7.5) document the effectiveness and tolerability of stiripentol in adults with before the genetic analysis. In the other nine cases, it was introduced DS. a few months to 6 years (median 1 year), after positive genetic testing for SCN1A mutation. At the time of stiripentol introduction, the mean number of AEDs already tried was 9 (range 3–15), and it 2 | MATERIAL AND METHODS was used with one to four concurrent AEDs. None of the cases was ever on monotherapy with stiripentol. Details of SCN1A mutations, This project was reviewed and registered as an observational clini- seizure types, AED history and age at introduction of stiripentol are cal audit at the National Hospital for Neurology and Neurosurgery, shown in Table 1. London (UK). Ethics committee approval is not required for an audit, as clinical audit by definition does not involve intervention 3.1 | Effectiveness beyond usual clinical management.23 We included all adults (>18 years) with DS attending the epilepsy The frequency of seizures (of any type) at the time of stiripentol service with previous or current treatment with stiripentol, from Jan- introduction varied from daily to weekly. The daily dose varied uary 2001 to July 2015. DS was defined according to the following from 250 mg to 3000 mg with a mean maximum daily dose of clinical criteria: seizure onset in the first year of life, with prior normal 1604 mg. Over an average time of exposure to stiripentol of psychomotor development, intractable epileptic seizures triggered by 42 months (range 3–139), more than 50% reduction in frequency infections and increased temperature, with no evidence of structural- of all seizure types was reported in three cases (23%). The other metabolic aetiology.1 Cases were identified by reviewing all known DS outcomes were: less than 50% reduction in frequency of all cases from clinical registers, reviewing all requests for SCN1A muta- seizure types in two cases (15%), no change in seizure frequency tion testing by the hospital clinical genetics service and local hospital in three cases (23%), more than 50% reduction in frequency of pharmacy prescriptions of stiripentol. Demographic and clinical infor- generalized tonic- clonic seizures (GTCs) but no change in fre- mation were gathered. quency of other seizure types in one case (8%), seizure exac- The following variables were included in the analysis: age, gen- erbation in three cases (23%) and undefined response in one der, age at clinical diagnosis, age at genetic testing, SCN1A mutation case (8%). One case had initially more than 50% reduction in details, seizure types, history of status epilepticus, antiepileptic drugs frequency of GTCs, from weekly to monthly GTCs with a 45 day (AEDs) tried before the introduction of stiripentol, age at introduction period without any GTCs, and became then free of GTCs for of stiripentol, interval between genetic diagnosis and introduction of about 12 months, followed by GTCs recurrence precipitated by stiripentol, AEDs initially used with stiripentol, mean monthly seizure intense physical exercise. Before introduction of stiripentol, eight frequency before the introduction of stiripentol and while on stiripen- patients (62%) had had from one to multiple episodes of status tol treatment, maximum dose of stiripentol, adverse effects during epilepticus. Of these cases, four had no further episodes of treatment with stiripentol, and total duration of exposure to stiripen- status after the introduction of stiripentol until the latest follow- tol. Seizure exacerbation was defined as an increase of more than up, over an average time of 43 months (range 3–139) on 25% in seizure frequency compared with seizure frequency before the stiripentol. introduction of stiripentol. Withdrawal due to lack of efficacy occurred in four cases (31%). Statistical analysis was performed using Stata/IC V.11.1 (Stata, In seven cases (54%), treatment was still ongoing at the time of the TX, USA). Descriptive statistics (mean, minimum, maximum, standard audit (July 2015), after they had been on stiripentol for an aver- deviation, and median—when appropriate) were used. age time of 62 months (range 10–139). The following medication changes were undertaken in these seven cases during the course of treatment with stiripentol: in two clobazam was introduced; in 3 | RESULTS one carbamazepine was withdrawn and clobazam introduced; in one phenytoin was withdrawn; in one sodium valproate was intro- We identified 32 adult cases with DS in our service. Thirteen adults duced; in one topiramate was withdrawn, sodium valproate, leveti- with DS and previous or current treatment with stiripentol were racetam, zonisamide and perampanel were introduced sequentially identified and comprised eight females and five males. DS was diag- (zonisamide was soon withdrawn due to lack of effectiveness) and a nosed on the basis of clinical findings, at a mean age of 24 (SD 11, vagus nerve stimulator was recently inserted; one did not have any range 2–41). Genetic analysis was undertaken at a mean age of 27 changes to concurrent AEDs. Five cases (39%) were on clobazam (SD 9, range 12–43). SCN1A mutation or rearrangements were found and 10 cases (77%) were on sodium valproate, as concurrent treat- in 12 of the 13 patients included.
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