Randomized, Single-Blind, Parallel Clinical Trial on Efficacy of Oral Prednisolone Versus Intramuscular Corticotropin on Immediate and Continued Spasm Control in West Syndrome

Wanigasinghe, Jithangi; Arambepola, Carukshi; Ranganathan, Shalini Sri; Sumanasena, Samanmali P; Attanapola, Gangani

doi:10.1016/j.pediatrneurol.2015.05.004

Cited by 65 publications

(117 citation statements)

References 22 publications

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“…In a follow‐up analysis that carefully adjusted for prescribing bias, response rates for ACTH and corticosteroids were nearly identical . In the only contemporary randomized controlled trial comparing high‐dose prednisolone (40–60 mg/day) with moderate‐dose sACTH (0.5–0.75 mg on alternate days), Waningasinghe and colleagues found that response to prednisolone was superior, although the response rate to sACTH was inexplicably low (36%) . It is critical to note that high‐dose ACTH has not been compared to high‐dose prednisolone in an adequately powered randomized controlled trial.…”

Section: Hormonal Therapymentioning

confidence: 99%

Treatment of infantile spasms

Hussain

2018

Epilepsia Open

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SummaryThe treatment of infantile spasms is challenging, especially in the context of the following: (1) a severe phenotype with high morbidity and mortality; (2) the urgency of diagnosis and successful early response to therapy; and (3) the paucity of effective, safe, and well‐tolerated therapies. Even after initially successful treatment, relapse risk is substantial and the most effective therapies pose considerable risk with long‐term administration. In evaluating any treatment for infantile spasms, the key short‐term outcome measure is freedom from both epileptic spasms and hypsarrhythmia. In contrast, the most important long‐term outcomes are enduring seizure‐freedom and measures of intellectual performance in later childhood and adulthood. First‐line treatment options—namely hormonal therapy and vigabatrin—display moderate to high efficacy but also exhibit substantial side‐effect burdens. Data on efficacy and safety of each class of therapy, as well as the combination of these therapies, are reviewed in detail. Specific hormonal therapies (adrenocorticotropic hormone and various corticosteroids) are contrasted. Those etiologies that prompt specific therapies are reviewed briefly, as are an array of second‐line therapies supported by less‐compelling data. The ketogenic diet is discussed in greater detail, with a focus on the limitations of numerous available studies that generally suggest that it is efficacious. Special discussion is allocated to cannabidiol—the investigational therapy that has received the most attention, and which is already in use in the form of various artisanal cannabis extracts. Finally, a treatment algorithm reflecting the concepts and controversies discussed in this review is presented.

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Section: Hormonal Therapymentioning

confidence: 99%

Treatment of infantile spasms

Hussain

2018

Epilepsia Open

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“…[38][39][40][41][42][43][44][45][46][47][48][49][50][51] A total of 1218 infants (age range = 0-24 months) were randomized to ACTH, prednisolone, prednisone, GVG, NZP, TPM, LEV, or PLB and followed for 1 week to 6.4 months ( Table 1). [38][39][40][41][42][43][44][45][46][47][48][49][50][51] A total of 1218 infants (age range = 0-24 months) were randomized to ACTH, prednisolone, prednisone, GVG, NZP, TPM, LEV, or PLB and followed for 1 week to 6.4 months ( Table 1).…”

Section: Infantile Spasms-west Syndromementioning

confidence: 99%

Comparative efficacy of antiepileptic drugs in children and adolescents: A network meta‐analysis

et al. 2017

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“…Although epileptic spasms and hypsarrhythmia resolve with time, many children develop other forms of drug-resistant epilepsy syndromes, and severe intellectual disabilities are shown in about 70%. [5][6][7] However, only ACTH treatment has class I evidence; therefore, it is the primary treatment option. Furthermore, the investigated drugs have frequently been started long after disease onset and in combination with or after multiple other antiepileptic drugs (AEDs).…”

Section: Introductionmentioning

confidence: 99%

Efficacy and tolerability of the ketogenic diet versus high‐dose adrenocorticotropic hormone for infantile spasms: A single‐center parallel‐cohort randomized controlled trial

et al. 2019

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Summary Objective To compare the efficacy and safety of the ketogenic diet (KD) with standard adrenocorticotropic hormone (ACTH) treatment in infants with West syndrome. Methods In this parallel‐cohort (PC) randomized controlled trial (RCT), infants were randomly allocated to KD or high‐dose ACTH. Those who could not be randomized were followed in a PC. Primary end point was electroclinical remission at day 28. Secondary end points were time to electroclinical remission, relapse after initial response, seizure freedom at last follow‐up, adverse effects, and developmental progress. Results One hundred one infants were included: 32 in the RCT (16 KD; 16 ACTH) and 69 in the PC (37 KD; 32 ACTH). Electroclinical remission at day 28 was similar between KD and ACTH (RCT: 62% vs 69%; PC: 41% vs 38%; combined cohort: 47% vs 48%; KD vs ACTH, respectively). In the combined cohort, time to electroclinical remission was similar between both treatments (14 days for KD, 16 days for ACTH). However, relapse rates were 16% (KD) and 43% (ACTH, P = 0.09), and seizure freedom at last follow‐up was 40% (KD) and 27% (ACTH, P = 0.18). Adverse effects needing acute medical intervention occurred more often with ACTH (30% with KD, 94% with ACTH, P < 0.001). Age‐appropriate psychomotor development and adaptive behavior were similar. Without prior vigabatrin (VGB) treatment, remission at day 28 was 47% (KD) and 80% (ACTH, P = 0.02); relapse rates were 29% (KD) and 56% (ACTH, P = 0.13). Consequently, seizure freedom at last follow‐up was similar. In infants with prior VGB, seizure freedom at last follow‐up was 48% (KD) and 21% (ACTH, P = 0.05). Significance The study is underpowered; therefore, its results should be interpreted with caution. KD is as effective as ACTH in the long term but is better tolerated. Without prior VGB treatment, ACTH remains the first choice to achieve short‐term remission. However, with prior VGB, KD was at least as effective as ACTH in the short term and was associated with lower relapse rates in the long term; therefore, it represents an appropriate second‐line treatment after VGB.

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Randomized, Single-Blind, Parallel Clinical Trial on Efficacy of Oral Prednisolone Versus Intramuscular Corticotropin on Immediate and Continued Spasm Control in West Syndrome

Cited by 65 publications

References 22 publications

Treatment of infantile spasms

Treatment of infantile spasms

Comparative efficacy of antiepileptic drugs in children and adolescents: A network meta‐analysis

Efficacy and tolerability of the ketogenic diet versus high‐dose adrenocorticotropic hormone for infantile spasms: A single‐center parallel‐cohort randomized controlled trial

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