Elsevier

Epilepsy Research

Volume 81, Issue 1, September 2008, Pages 80-85
Epilepsy Research

A comparative study of hydrocortisone versus deflazacort in drug-resistant epilepsy of childhood

https://doi.org/10.1016/j.eplepsyres.2008.04.016Get rights and content

Summary

Steroids are commonly used for the treatment of intractable epilepsy. Deflazacort has shown similar effects to prednisone, but with a less worrying adverse-effect profile. In this study, we first compared the efficacy, safety, and seizure relapse rate of deflazacort versus hydrocortisone in children affected by drug-resistant epilepsies.

This was an open, non-blinded, randomized clinical study of 35 children affected by drug-resistant epilepsies. The study lasted 12 months. Group 1 (16 patients) received hydrocortisone for 6 months; group 2 (19 patients) was treated with deflazacort for the entire study period. Drug efficacy and tolerability were evaluated after 6 months of therapy. Seizure relapse rates were evaluated 12 months after the start of the study.

After 6 months of therapy, hydrocortisone was effective in 44% of patients (responders, with a decrease in seizure frequency of >50%). Deflazacort was effective in 47% of patients (P = 0.9). Adverse events occurred in 37% of patients using hydrocortisone and in none of those using deflazacort (P = 0.002). At the end of the study, seizure relapse rate resulted significantly higher in group 1 than in group 2 (P = 0.04).

Hydrocortisone may be useful in the treatment of severely drug-resistant childhood epilepsies. However, its effects may be transient. Deflazacort should be considered in the therapeutic armamentarium for epileptic encephalopathies. The drug is as effective as hydrocortisone and may be used in therapy for a long period, with a less worrying adverse-effect profile.

Introduction

Steroids are commonly used in the treatment of intractable seizures (Prasad et al., 1996, Yoshikawa et al., 2000, Gupta and Appleton, 2005, Kneen and Appleton, 2006). However, their efficacy in controlling seizures and in improving cognition and quality of life is yet to be clearly established (Gayatri et al., 2007). Excluding epileptic spasms, there is no reliable evidence from randomized controlled trials to support the use of steroids in childhood epilepsy. Nevertheless, in clinical practice, steroids are considered first-line drugs in the treatment of infantile spasms and Landau–Kleffner syndrome. In the latter epilepsy syndrome, several types of steroids have been used as monotherapies or in association with traditional antiepilepsy drugs (AEDs). They include hydrocortisone (Marescaux et al., 1990), prednisolone (Marescaux et al., 1990, Gallagher et al., 2006), dexamethasone (Lerman et al., 1991), prednisone (Sinclair, 2003, Sinclair and Snyder, 2005, Verhelst et al., 2005), and adrenocorticotropic hormone (ACTH) (Lerman et al., 1991, O’Regan and Brown, 1998). Steroids have also been used in epilepsy with continuous spike-wave discharges (CSWS) and in the early and explosive onset of epileptic encephalopathies, including Rasmussen's encephalitis, where there may be an autoimmune or postinfectious inflammatory cause (Gupta and Appleton, 2005). Far less clear or defined is the use of steroids for other seizure types, such as myoclonic or myoclonic–astatic (“drop”) seizures and epilepsy syndromes such as Lennox–Gastaut syndrome and Ohtahara syndrome (Gupta and Appleton, 2005).

Deflazacort, a derivative of prednisolone, has been used in several disorders because of its proven efficacy and few adverse effects.

In this study, we compared the efficacy, safety, and seizure relapse rate of deflazacort versus hydrocortisone in a pediatric population with refractory epilepsy syndromes after the first year of life.

Section snippets

Study design

The setting of this open, non-blinded, randomized study was typical of routine clinical practice. Parents and caregivers gave informed consent and all procedures followed were in accordance with institutional guidelines. Patients affected by neurodegenerative disorders were excluded from the study.

Group 1 patients received hydrocortisone; group 2 patients were placed on deflazacort. Patients were allocated to either treatment group on an alternate basis of hospitalization. The doses of the

Results

Sixteen patients (seven girls and nine boys), designated group 1, were treated with hydrocortisone, and 19 (eight girls and 11 boys), designated group 2, with deflazacort. There were no statistically significant differences in sex, mean age at onset of epilepsy, mean age at therapy, time interval between first seizure and therapy, seizure type, seizure frequency, findings on EEG or MRI, mental status, presence of regression, or etiological diagnosis between the two groups of patients or, when

Discussion

Very few studies have compared the effectiveness of diverse corticosteroids for seizures other than infantile spasms. Moreover, comparisons between various studies are difficult because of the different treatment protocols used (Glaze et al., 1988). Snead et al. (1983) compared the efficacy of prednisone and ACTH in 64 children with seizure types other than infantile spasms. Prednisone was given at a dose of 3 mg/kg per day for 4 weeks, followed by 3 mg/kg on alternate days for 4 weeks, and then

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