Valproic acid hepatic fatalities: a retrospective review.

We reviewed all US cases of fatal hepatotoxicity coincident with valproate anticonvulsant therapy that were reported between 1978 and 1984. Thirty-seven hepatic fatalities were determined to have occurred coincident with the use of valproate. All but one patient had such other medical conditions as mental retardation, developmental delay, congenital abnormalities, and other neurologic diseases. The primary risk of fatal hepatic dysfunction (1/500) was found to be in children 0 to 2 years old receiving valproate as polytherapy. The risk declined with age and was low in patients receiving valproate as monotherapy (1/37,000). No hepatic fatalities occurred in patients above the age of 10 years receiving valproate as monotherapy.

A controlled study of progabide in partial seizures: methodology and results.

The results of a multicenter, double-blind, placebo-controlled clinical trial of the efficacy and safety of progabide (PGB) in the treatment of partial seizures are presented. This study was performed with a number of rigorous controls not usually present in clinical trials. These included uniform co-medication in which all patients received only phenytoin and carbamazepine; concentrations of these two drugs were maintained within narrow, predefined concentration ranges. There was no statistically significant difference between PGB and placebo in seizure frequency and seizure duration for most of the analyses performed. One patient was withdrawn from the study because of hepatotoxicity. PGB was associated with a significant inhibition of phenytoin but not carbamazepine clearance. The results of this study indicate that PGB was not a potent antiepileptic drug in this population of persons with intractable epilepsy.

Immunochromatographic measurement of phenobarbital in whole blood with a non-instrumented assay.

We tested the precision and accuracy of the AccuLevel Phenobarbital Test, which reports whole-blood (fingerstick) results in plasma equivalent values, and compared these values with plasma results obtained using established methods. We conclude that the assay is precise, reliable, accurate for single tests, and is appropriate for use in offices, outpatient settings, and emergency rooms.

Felbamate for partial seizures: results of a controlled clinical trial.

Felbamate (2-phenyl-1,3-propanediol dicarbamate) has a favorable preclinical profile in animal models of epilepsy. We present the results of a double-blind, randomized, placebo-controlled clinical trial in patients with partial seizures. Criteria for entry included a requirement for four or more partial seizures per month despite concomitant therapeutic blood levels of phenytoin and carbamazepine. Fifty-six patients (mean age, 31.4 years; 32 men, 24 women) completed the trial. The mean seizure frequencies for the 8-week periods analyzed were felbamate = 34.9, placebo = 40.2. Felbamate was statistically superior to placebo in seizure reduction, percent seizure reduction, and truncated percent seizure reduction. The mean felbamate dosage was 2,300 mg/d. Plasma felbamate concentrations ranged from 18.4 to 51.9 mg/l, mean = 32.5 mg/l. Adverse experiences during felbamate therapy were minor and consisted primarily of nausea and CNS effects. This trial indicates that felbamate is safe and effective in the treatment of comedicated patients with severely refractory epilepsy.

Enhancing moral growth: is communication the key?

Traditional approaches in stimulating moral growth following Turiel's (1966) "+1" intervention strategy have been only marginally successful. This failure rate may be due to (a) the inconsistent control of both the cognitive and social perspective-taking prerequisites to moral growth, and (b) an overestimation of subjects' interpersonal communication skills. In this study, 17 college undergraduates (8 males, 9 females), possessing either basic or consolidated formal operations, received eight weeks of interpersonal skills training, along with pre- and posttraining assessments of social perspective-taking and moral reasoning. It was expected that gains in moral reasoning would be related to subjects' possessing the prerequisite cognitive and perspective-taking competencies necessary for moral growth. Results showed that posttraining changes in moral reasoning were in the predicted direction. In addition, gender differences in social perspective-taking were evident; males had significantly lower social perspective-taking scores at pretraining and showed significant gains in perspective-taking at posttesting. Females, however, scored relatively high in social perspective-taking at pretraining and showed no significant change in ability at posttesting. The results are interpreted as supportive of existing theoretical models regarding these domains of development.