"Treatment of Generalized Convulsive Status Epilepticus". The New England Journal of Medicine. 1998. 339(12):792-798. PubMed
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Contents 1 Clinical Question 2 Bottom Line 3 Major Points 4 Guidelines 5 Design 6 Population 6.1 Inclusion Criteria 6.2 Exclusion Criteria 6.3 Baseline Characteristics 7 Interventions 8 Outcomes 8.1 Primary Outcome 8.2 Secondary Outcomes 9 Criticisms 10 Funding 11 Further Reading
In patients with generalized convulsive status epilepticus, which initial intravenous treatment is most effective: diazepam followed by phenytoin, lorazepam, phenobarbital, or phenytoin?
As initial intravenous treatment for overt generalized convulsive status epilepticus, lorazepam is more effective than phenytoin and easier to use compared to phenobarbital or diazepam followed by phenytoin.
Generalized convulsive status epilepticus is a life-threatening condition requiring immediate and effective treatment. Standard options have included diazepam followed by phenytoin, lorazepam, phenobarbital, and phenytoin, but their relative effectiveness had not been well established.
Current guidelines for the management of status epilepticus often recommend lorazepam as the first-line treatment based in part on the results of this study.
- Multicenter, double-blind, randomized, controlled trial - N=570 patients with generalized convulsive status epilepticus - Interventions: - Diazepam (0.15 mg/kg) followed by phenytoin (18 mg/kg) - Lorazepam (0.1 mg/kg) - Phenobarbital (15 mg/kg) - Phenytoin (18 mg/kg) - Setting: 22 Veterans Affairs medical centers and affiliated hospitals - Enrollment: 1990-1995 - Analysis: Intention-to-treat and verified diagnosis - Primary outcome: Cessation of all clinical and electrical evidence of seizure activity within 20 minutes without recurrence during the following 40 minutes
- Inclusion Criteria: Patients with recurrent generalized convulsions or continuous convulsive activity, age ≥18 years - Exclusion Criteria: Pregnancy, status epilepticus other than generalized convulsive, neurologic emergencies requiring immediate surgery, contraindications for hydantoin, benzodiazepine, or barbiturate. - Baseline Characteristics: Varied across types of status epilepticus (overt or subtle), with significant differences evident in numerous clinical aspects
- Intravenous administration of one of four treatments with standardized dosing based on patient weight - Separate randomization for overt and subtle generalized convulsive status epilepticus - Strict time frames for infusion and assessment of treatment efficacy
- Primary Outcome: Among 518 patients with verified overt generalized convulsive status epilepticus, lorazepam was successful in 64.9%, phenobarbital in 58.2%, diazepam plus phenytoin in 55.8%, and phenytoin in 43.6% (P=0.02 for overall comparison). Lorazepam was significantly superior to phenytoin alone (P=0.002). - Secondary Outcomes: No differences among treatments in rate of recurrence during the 12-hour study period, the incidence of adverse reactions, or 30-day outcome.
- The criteria for treatment success may not have allowed sufficient time for phenytoin to achieve its full effect due to its slower rate of administration.
Funded by the Department of Veterans Affairs Medical Research Service Cooperative Studies Program. Lorazepam and dummy lorazepam Tubexes donated by Wyeth–Ayerst Laboratories. Authors disclosed various consultancies including with companies supplying study medications.
The full text of the study can be accessed at The New England Journal of Medicine website.