The efficacy, bioavailability and safety of carbamazepine when administered alone as an antiepileptic drug was evaluated in a double blind study of 45 institutionalized patients with uncontrolled seizures. During each of three 21 day treatment periods, 1/3 of the patients were assigned to receive either phenytoin (300 mg/day) phenobarbital (300 mg/day) or carbamazepine (1200 mg/day). 2 wk of regular medication (usual prestudy medication) separated each 21 day treatment period. Tablets containing carbamazepine (or placebo before phenytoin or phenobarbital treatment periods) were started 3 days before cessation of regular medication to provide a serum carbamazepine concentration at the time of cessation and to minimize transient side effects during initiation of carbamazepine therapy. Carbamazepine dosages during the 3 day period were 400, 800 and 1200 mg, respectively. Patients were returned to regular medication if they experienced excess seizures (defined as 4, or the equivalent of 4, tonic clonic seizures in an 8 hr period) during a treatment period. Analysis by a replicated Latin square model showed that the 3 drugs, when administered alone, were equal in their efficacy for control of seizures. During initiation of carbamazepine therapy, 26 of the 45 patients experienced malaise, visual disturbance, and difficulty with balance and performance of movement, without objective neurologic findings. These symptoms subsided within the first 5 days. The highest serum carbamazepine concentration measured was 13.7 mg/ml, with 70% of the values ranging from 5 to 10 mcg/ml.
|Original language||English (US)|
|Number of pages||1|
|State||Published - Dec 1 1973|
ASJC Scopus subject areas
- Clinical Neurology