Question What is the comparative efficacy of 4 intravenous drug therapies (lorazepam, phénobarbital, phenytoin, and diazepam followed by phenytoin) for generalized convulsive status epilepticus? Design Randomized, double-blind, controlled trial with 12-hour follow-up. Setting 16 Veterans Affairs medical centers and 6 affiliated university hospitals in the United States. Patients 570 patients with generalized convulsive status epilepticus. 395 patients had overt status epilepticus defined as ≥ 2 generalized convulsions without full recovery of consciousness between seizures or continuous convulsive activity for > 10 minutes. 175 patients had subtle status epilepticus, defined as coma and ictal discharges on electroencephalography, widi or without subtle convulsive movements. Exclusion criteria were age < 18 years, pregnancy, neurosurgical emergencies, or contraindications to study drugs. 518 patients (mean age 59.5 y, 83% men) had confirmed diagnoses. Intervention Patients were allocated to intravenous lorazepam, 0.1 mg/kg of body weight (n = 146); phénobarbital, 15 mg/kg (n = 133);phenytoin, 18mg/kg(n= 145); or diazepam, 0.15 mg/kg, followed by phenytoin, 18 mg/kg (n = 146). Main outcome measures Treatment success, defined as resolution of all clinical and electrical evidence of seizures within 20 minutes of initiation of treatment without recurrence within 20 to 60 minutes; recurrence widiin 12 hours; and adverse effects. Main results Intention-to-treat analyses showed no differences in the success rates of the 4 treatments for overt status epilepticus (F = 0.12) or subtle status epilepticus (P = 0.91) (Table). Analysis of 384 patients with confirmed overt status epilepticus showed that lorazepam had a higher success rate than phenytoin alone (P = 0.002). Analysis of 134 patients with confirmed subtle status epilepticus found no overall differences among treatments. The groups did not differ for recurrence among successfully treated patients at 12 hours or for adverse effects. Conclusion Among patients with generalized convulsive status epilepticus, initial intravenous treatment with lorazepam, phénobarbital, phenytoin, or diazepam followed by phenytoin had similar efficacies, recurrence rates, and adverse effects.
|Original language||English (US)|
|Number of pages||1|
|State||Published - Dec 1 1999|
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