| HOME | HELP | FEEDBACK | SUBSCRIPTIONS | ARCHIVE | SEARCH | TABLE OF CONTENTS |
|
|
|
|||||||
|
|||||||||
*Members of the US Infantile Spasms Vigabatrin Study Group are listed in the Appendix on page 1421.
From the Medical City Dallas Hospital (Drs. Elterman and Mansfield), TX; and Mattel Children’s Hospital (Drs. Shields and Nakagawa), University of California, Los Angeles.
Address correspondence and reprint requests to Dr. Roy D. Elterman, Dallas Pediatric Neurology Associates, The Center for Epilepsy Treatment, Medical City Dallas Hospital, 7777 Forest Lane, Suite A307, Dallas, TX 75230; e-mail: RoyDElterman{at}aol.com
Background: — Infantile spasms are a rare but devastating pediatric epilepsy that, outside the United States, is often treated with vigabatrin. The authors evaluated the efficacy and safety of vigabatrin in children with recent-onset infantile spasms.
Methods:— This 2-week, randomized, single-masked, multicenter study with a 3- year, open-label, dose-ranging follow-up study included patients who were younger than 2 years of age, had a diagnosed duration of infantile spasms of no more than 3 months, and had not previously been treated with adrenocorticotropic hormone, prednisone, or valproic acid. Patients were randomly assigned to receive low-dose (18–36 mg/kg/day) or high-dose (100–148 mg/kg/day) vigabatrin. Treatment responders were those who were free of infantile spasm for 7 consecutive days beginning within the first 14 days of vigabatrin therapy. Time to response to therapy was evaluated during the first 3 months, and safety was evaluated for the entire study period.
Results:— Overall, 32 of 142 patients who were able to be evaluated for efficacy were treatment responders (8/75 receiving low-dose vigabatrin vs 24/67 receiving high doses, p < 0.001). Response increased dramatically after approximately 2 weeks of vigabatrin therapy and continued to increase over the 3-month follow-up period. Time to response was shorter in those receiving high-dose versus low-dose vigabatrin (p = 0.04) and in those with tuberous sclerosis versus other etiologies (p < 0.001). Vigabatrin was well tolerated and safe; only nine patients discontinued therapy because of adverse events.
Conclusions:— These results confirm previous reports of the efficacy and safety of vigabatrin in patients with infantile spasms, particularly among those with spasms secondary to tuberous sclerosis.
This article has been cited by other articles:
|
|
 |
|
  I. Desguerre, R. Nabbout, and O. Dulac The management of infantile spasms Arch. Dis. Child., June 1, 2008; 93(6): 462 - 463. [Full Text] [PDF]
|
|
|
|
 |
|
 A. Partikian and W. G. Mitchell Major Adverse Events Associated With Treatment of Infantile Spasms J Child Neurol, December 1, 2007; 22(12): 1360 - 1366. [Abstract] [PDF]
|
|
|
|
 |
|
 S. Goh, D. J. Kwiatkowski, D. J. Dorer, and E. A. Thiele Infantile spasms and intellectual outcomes in children with tuberous sclerosis complex Neurology, July 26, 2005; 65(2): 235 - 238. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
E. A. Thiele Managing Epilepsy in Tuberous Sclerosis Complex J Child Neurol, September 1, 2004; 19(9): 680 - 686. [Abstract] [PDF]
|
|
|
|
|
|
W. D. Shields Management of Epilepsy in Mentally Retarded Children Using the Newer Antiepileptic Drugs, Vagus Nerve Stimulation, and Surgery J Child Neurol, August 1, 2004; 19(1_suppl): S58 - S64. [Abstract] [PDF]
|
|
|
|
|
|
R. Riikonen Topical Review: Infantile Spasms: Therapy and Outcome J Child Neurol, June 1, 2004; 19(6): 401 - 404. [Abstract] [PDF]
|
|
|
|
|
|
M. T. Mackay, S. K. Weiss, T. Adams-Webber, S. Ashwal, D. Stephens, K. Ballaban-Gill, T. Z. Baram, M. Duchowny, D. Hirtz, J. M. Pellock, et al. Practice Parameter: Medical Treatment of Infantile Spasms: Report of the American Academy of Neurology and the Child Neurology Society Neurology, May 25, 2004; 62(10): 1668 - 1681. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
W. D. Shields Management of Epilepsy in Mentally Retarded Children Using the Newer Antiepileptic Drugs, Vagus Nerve Stimulation, and Surgery J Child Neurol, January 1, 2004; 19(1_suppl): S58 - S64. [Abstract] [PDF]
|
|
|
|
 |
|
 D. K. Nguyen and S. S. Spencer Recent Advances in the Treatment of Epilepsy Arch Neurol, July 1, 2003; 60(7): 929 - 935. [Full Text] [PDF]
|
|
|
|
|
|
P. Kwan and M. J. Brodie Clinical trials of antiepileptic medications in newly diagnosed patients with epilepsy Neurology, June 10, 2003; 60(90114): S2 - 12. [Abstract] [Full Text]
|
|
|
|
|
|
P. Camfield and C. Camfield Childhood Epilepsy: What Is the Evidence for What We Think and What We Do? J Child Neurol, April 1, 2003; 18(4): 272 - 287. [Abstract] [PDF]
|
|
|
|
 |
|
 E. H. Kossoff, P. L. Pyzik, J. R. McGrogan, E. P. G. Vining, and J. M. Freeman Efficacy of the Ketogenic Diet for Infantile Spasms Pediatrics, May 1, 2002; 109(5): 780 - 783. [Abstract] [Full Text] [PDF]
|
|
|
|
|
|
E. Trevathan Infantile Spasms and Lennox-Gastaut Syndrome J Child Neurol, February 1, 2002; 17(2_suppl): 2S9 - 2S22. [Abstract] [PDF]
|
|
|
|
|
|
W. D. Shields West's Syndrome J Child Neurol, January 1, 2002; 17(1_suppl): S76 - S79. [Abstract] [PDF]
|
|
Read all Correspondence
| HOME | HELP | FEEDBACK | SUBSCRIPTIONS | ARCHIVE | SEARCH | TABLE OF CONTENTS |
