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The United Kingdom Infantile Spasms Study comparing vigabatrin with prednisolone or tetracosactide at 14 days: a multicentre, randomised controlled trial

The United Kingdom Infantile Spasms Study comparing vigabatrin with prednisolone or tetracosactide at 14 days: a multicentre, randomised controlled trial
The United Kingdom Infantile Spasms Study comparing vigabatrin with prednisolone or tetracosactide at 14 days: a multicentre, randomised controlled trial
Background
Infantile spasms, which comprise a severe infantile seizure disorder, have a high morbidity and are difficult to treat. Hormonal treatments (adrenocorticotropic hormone and prednisolone) have been the main therapy for decades, although little evidence supports their use. Vigabatrin has been recorded to have a beneficial effect in this disorder. We aimed to compare the effects of vigabatrin with those of prednisolone and tetracosactide in the treatment of infantile spasms.
Methods
The United Kingdom Infantile Spasms Study assessed these treatments in a multicentre, randomised controlled trial in 150 hospitals in the UK. The primary outcome was cessation of spasms on days 13 and 14. Minimum doses were vigabatrin 100 mg/kg per day, oral prednisolone 40 mg per day, or intramuscular tetracosactide depot 0·5 mg (40 IU) on alternate days. Analysis was by intention to treat.
Findings
Of 208 infants screened and assessed, 107 were randomly assigned to vigabatrin (n=52) or hormonal treatments (prednisolone n=30, tetracosactide n=25). None was lost to follow-up. Proportions with no spasms on days 13 and 14 were: 40 (73%) of 55 infants assigned hormonal treatments (prednisolone 21/30 [70%], tetracosactide 19/25 [76%]) and 28 (54%) of 52 infants assigned vigabatrin (difference 19%, 95% CI 1%–36%, p=0·043). Two infants allocated tetracosactide and one allocated vigabatrin received prednisolone. Adverse events were reported in 30 (55%) of 55 infants on hormonal treatments and 28 (54%) of 52 infants on vigabatrin. No deaths were recorded.
Interpretation
Cessation of spasms was more likely in infants given hormonal treatments than those given vigabatrin. Adverse events were common with both treatments.
0140-6736
1773-1778
Lux, Andrew L.
12152c58-06cc-4751-8c45-4b2b98f0ec30
Edwards, Stuart W.
a3d25075-5ca4-43fa-8ca5-4932ddd1ee06
Hancock, Eleanor
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Johnson, Anthony L.
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Kennedy, Colin R.
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Newton, Richard W.
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O'Callaghan, Finbar J. K.
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Verity, Christiopher M.
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Osborne, John P.
db90ab19-3de3-49a8-b82a-b050a1180e6f
Lux, Andrew L.
12152c58-06cc-4751-8c45-4b2b98f0ec30
Edwards, Stuart W.
a3d25075-5ca4-43fa-8ca5-4932ddd1ee06
Hancock, Eleanor
0aac9197-3944-40b6-a4f4-b3f40bd3b602
Johnson, Anthony L.
f3bbadf1-d1a1-4b09-8d7f-2e9b86aa25dd
Kennedy, Colin R.
7c3aff62-0a86-4b44-b7d7-4bc01f23ec93
Newton, Richard W.
b307ba85-c13b-40f7-9c05-ba1b4bafd922
O'Callaghan, Finbar J. K.
bc68aacb-29fc-42cd-bb88-823cc38eba66
Verity, Christiopher M.
6ce1db39-2350-4692-a9d5-e432c7b3d5f7
Osborne, John P.
db90ab19-3de3-49a8-b82a-b050a1180e6f

Lux, Andrew L., Edwards, Stuart W., Hancock, Eleanor, Johnson, Anthony L., Kennedy, Colin R., Newton, Richard W., O'Callaghan, Finbar J. K., Verity, Christiopher M. and Osborne, John P. (2004) The United Kingdom Infantile Spasms Study comparing vigabatrin with prednisolone or tetracosactide at 14 days: a multicentre, randomised controlled trial. The Lancet, 364 (9447), 1773-1778. (doi:10.1016/S0140-6736(04)17400-X).

Record type: Article

Abstract

Background
Infantile spasms, which comprise a severe infantile seizure disorder, have a high morbidity and are difficult to treat. Hormonal treatments (adrenocorticotropic hormone and prednisolone) have been the main therapy for decades, although little evidence supports their use. Vigabatrin has been recorded to have a beneficial effect in this disorder. We aimed to compare the effects of vigabatrin with those of prednisolone and tetracosactide in the treatment of infantile spasms.
Methods
The United Kingdom Infantile Spasms Study assessed these treatments in a multicentre, randomised controlled trial in 150 hospitals in the UK. The primary outcome was cessation of spasms on days 13 and 14. Minimum doses were vigabatrin 100 mg/kg per day, oral prednisolone 40 mg per day, or intramuscular tetracosactide depot 0·5 mg (40 IU) on alternate days. Analysis was by intention to treat.
Findings
Of 208 infants screened and assessed, 107 were randomly assigned to vigabatrin (n=52) or hormonal treatments (prednisolone n=30, tetracosactide n=25). None was lost to follow-up. Proportions with no spasms on days 13 and 14 were: 40 (73%) of 55 infants assigned hormonal treatments (prednisolone 21/30 [70%], tetracosactide 19/25 [76%]) and 28 (54%) of 52 infants assigned vigabatrin (difference 19%, 95% CI 1%–36%, p=0·043). Two infants allocated tetracosactide and one allocated vigabatrin received prednisolone. Adverse events were reported in 30 (55%) of 55 infants on hormonal treatments and 28 (54%) of 52 infants on vigabatrin. No deaths were recorded.
Interpretation
Cessation of spasms was more likely in infants given hormonal treatments than those given vigabatrin. Adverse events were common with both treatments.

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Published date: 2004
Organisations: Clinical Neurosciences

Identifiers

Local EPrints ID: 27643
URI: http://eprints.soton.ac.uk/id/eprint/27643
ISSN: 0140-6736
PURE UUID: 276e714c-a52d-4423-8cc4-97b2857fb8d2

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Date deposited: 28 Apr 2006
Last modified: 15 Mar 2024 07:20

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Contributors

Author: Andrew L. Lux
Author: Stuart W. Edwards
Author: Eleanor Hancock
Author: Anthony L. Johnson
Author: Richard W. Newton
Author: Finbar J. K. O'Callaghan
Author: Christiopher M. Verity
Author: John P. Osborne

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