Status epilepticus and tiagabine therapy: Review of safety data and epidemiologic comparisons

Shlomo Shinnar, Anne T. Berg, David M. Treiman, W. Allen Hauser, Dale C. Hesdorffer, J. Chris Sackellares, Ilo Leppik, Matti Sillanpaa, Kenneth W. Sommerville

Research output: Contribution to journalArticle

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Abstract

Purpose: To determine whether an increased risk of status epilepticus (SE) and complex partial status epilepticus (CPSE) is associated with tiagabine (TGB) therapy. Methods: Thirteen cases in which an EEG, performed on patients with altered mental status taking TGB, was reported to demonstrate spike-and-wave discharges (SWDs) were reviewed by a panel of experts. In addition, all cases of suspected SE from TGB clinical trials were reviewed. The occurrence of SE in four epidemiologic cohorts from Rochester, Minnesota, Turku, Finland, Bronx, New York, and New Haven, Connecticut was analyzed as an external comparison. Results: Review of the 13 cases with reported SWDs found that the majority had had prior EEGs with similar findings, and only three were thought to have electrographic evidence of SE. There was no difference in the frequency of SE or CPSE in the placebo-controlled clinical trials between the TGB-treated (1.0% SE, 0.8% CPSE) and placebo-treated (1.5% SE, 1.5% CPSE) groups. The 5% frequency of SE and 3% frequency of CPSE in the TGB-treated patients in the long-term safety studies, which included 2,248 patients, were very similar to the rates of occurrence of SE and CPSE in the four external cohorts. The major risk factor for the occurrence of SE and CPSE in all groups was a prior episode of SE (p < 0.0001). Conclusions: Over a 3-year period, SE will occur in 5-10% of patients with epilepsy not in remission. At highest risk are those who have had a prior episode of SE. Treatment with TGB in recommended doses does not increase the risk of SE in patients with partial seizures.

Original languageEnglish (US)
Pages (from-to)372-379
Number of pages8
JournalEpilepsia
Volume42
Issue number3
DOIs
StatePublished - 2001

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Status Epilepticus
Safety
Therapeutics
tiagabine
Electroencephalography
Placebos

Keywords

  • Electroencephalography
  • Epidemiology
  • GABA
  • Status epilepticus
  • Tiagabine

ASJC Scopus subject areas

  • Clinical Neurology
  • Neuroscience(all)

Cite this

Shinnar, S., Berg, A. T., Treiman, D. M., Allen Hauser, W., Hesdorffer, D. C., Chris Sackellares, J., ... Sommerville, K. W. (2001). Status epilepticus and tiagabine therapy: Review of safety data and epidemiologic comparisons. Epilepsia, 42(3), 372-379. https://doi.org/10.1046/j.1528-1157.2001.01600.x

Status epilepticus and tiagabine therapy : Review of safety data and epidemiologic comparisons. / Shinnar, Shlomo; Berg, Anne T.; Treiman, David M.; Allen Hauser, W.; Hesdorffer, Dale C.; Chris Sackellares, J.; Leppik, Ilo; Sillanpaa, Matti; Sommerville, Kenneth W.

In: Epilepsia, Vol. 42, No. 3, 2001, p. 372-379.

Research output: Contribution to journalArticle

Shinnar, S, Berg, AT, Treiman, DM, Allen Hauser, W, Hesdorffer, DC, Chris Sackellares, J, Leppik, I, Sillanpaa, M & Sommerville, KW 2001, 'Status epilepticus and tiagabine therapy: Review of safety data and epidemiologic comparisons', Epilepsia, vol. 42, no. 3, pp. 372-379. https://doi.org/10.1046/j.1528-1157.2001.01600.x
Shinnar, Shlomo ; Berg, Anne T. ; Treiman, David M. ; Allen Hauser, W. ; Hesdorffer, Dale C. ; Chris Sackellares, J. ; Leppik, Ilo ; Sillanpaa, Matti ; Sommerville, Kenneth W. / Status epilepticus and tiagabine therapy : Review of safety data and epidemiologic comparisons. In: Epilepsia. 2001 ; Vol. 42, No. 3. pp. 372-379.
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abstract = "Purpose: To determine whether an increased risk of status epilepticus (SE) and complex partial status epilepticus (CPSE) is associated with tiagabine (TGB) therapy. Methods: Thirteen cases in which an EEG, performed on patients with altered mental status taking TGB, was reported to demonstrate spike-and-wave discharges (SWDs) were reviewed by a panel of experts. In addition, all cases of suspected SE from TGB clinical trials were reviewed. The occurrence of SE in four epidemiologic cohorts from Rochester, Minnesota, Turku, Finland, Bronx, New York, and New Haven, Connecticut was analyzed as an external comparison. Results: Review of the 13 cases with reported SWDs found that the majority had had prior EEGs with similar findings, and only three were thought to have electrographic evidence of SE. There was no difference in the frequency of SE or CPSE in the placebo-controlled clinical trials between the TGB-treated (1.0{\%} SE, 0.8{\%} CPSE) and placebo-treated (1.5{\%} SE, 1.5{\%} CPSE) groups. The 5{\%} frequency of SE and 3{\%} frequency of CPSE in the TGB-treated patients in the long-term safety studies, which included 2,248 patients, were very similar to the rates of occurrence of SE and CPSE in the four external cohorts. The major risk factor for the occurrence of SE and CPSE in all groups was a prior episode of SE (p < 0.0001). Conclusions: Over a 3-year period, SE will occur in 5-10{\%} of patients with epilepsy not in remission. At highest risk are those who have had a prior episode of SE. Treatment with TGB in recommended doses does not increase the risk of SE in patients with partial seizures.",
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AU - Berg, Anne T.

AU - Treiman, David M.

AU - Allen Hauser, W.

AU - Hesdorffer, Dale C.

AU - Chris Sackellares, J.

AU - Leppik, Ilo

AU - Sillanpaa, Matti

AU - Sommerville, Kenneth W.

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