Optimization of phenytoin therapy in adults with epilepsy in the Western Cape, South Africa.

OBJECTIVE: To assess the extent to which adults with epilepsy were optimized and individualized on phenytoin monotherapy in the Western Cape, South Africa and to estimate the average optimized dose and serum phenytoin concentration, and the therapeutic range for this patient group. METHODS: Patients were considered to be optimized on phenytoin if they were seizure-free or the best compromise was achieved between seizure reduction and side-effects. RESULTS: 538 (233 black and 305 coloured) adult people with epilepsy were treated at nine epilepsy clinics as outpatients. Of these patients, 332 (226 male and 106 female, 149 black and 183 coloured) were included in the data analysis as they were considered to have reliable phenytoin levels. Phenytoin doses and steady-state serum concentrations were predicted using the Michaelis-Menten equation. Patients attended a clinical pharmacokinetic service for 7.7+/-5.3 (range 1-22) months. The average optimized dose was 305.8 (range 100-500) mg/day and the average optimized level was 62.7+/-23.9 (range 15-133) micromol/l. Most patients (61.9%) were optimized in the therapeutic range 40-79 micromol/l; 21.1% were optimized above and 17% below this range. In 1.6% of patients serum concentrations above 120 micromol/l were required. Dosage adjustments were made in 47.0% of patients, increased in 31.9% and reduced in 15.1%. CONCLUSION: These findings indicate that many patients (47%) attending outpatient clinics were not optimized on phenytoin therapy.