Status epilepticus and tiagabine therapy: review of safety data and epidemiologic comparisons.
OBJECTIVE
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.
Shinnar
S
S
Department and Pediatrics and Comprehensive Epilepsy Management Center, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York 10467, USA.
Berg
A T
AT
Treiman
D M
DM
Hauser
W A
WA
Hesdorffer
D C
DC
Sackellares
J C
JC
Leppik
I
I
Sillanpaa
M
M
Sommerville
K W
KW
D000293:Adolescent; D000328:Adult; D000927:Anticonvulsants / Q000009:adverse effects* / Q000627:therapeutic use; D002648:Child; D015331:Cohort Studies; D018849:Controlled Clinical Trials as Topic / Q000706:statistics & numerical data; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D004569:Electroencephalography / Q000187:drug effects / Q000706:statistics & numerical data*; D004828:Epilepsies, Partial / Q000188:drug therapy*; D017029:Epilepsy, Complex Partial / Q000139:chemically induced / Q000175:diagnosis / Q000453:epidemiology; D005260:Female; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D009557:Nipecotic Acids / Q000009:adverse effects* / Q000627:therapeutic use; D010919:Placebos; D012307:Risk Factors; D013226:Status Epilepticus / Q000139:chemically induced* / Q000175:diagnosis / Q000453:epidemiology; D000078308:Tiagabine
D000927:Anticonvulsants; D009557:Nipecotic Acids; D010919:Placebos; D000078308:Tiagabine