Compliance of epileptic patients is one of the most important factors for adequate therapy. Recently, it had been shown that the variability of three serial measurement of the serum levels of antiepileptic drug(AED) may be used as an indication of the degree of compliance. Coefficient variation(CV) of serum drug levels calculated by only one AED had been used to determine the compliance in epileptic patients who took multiple AEDs. We attempted to evaluate the CV of AEDs and then find the objective clue of compliance and the compatible therapeutic planing according to CV. Ninety seven epileptic patients of outpatients department of the Gyengsang National University Hospital were entered to this study. All patients were taking medication at least for 6 months without any changes of drug regimen. Patient's information was acquired by reviewing the chart and interview with questionnaire. With these informations, we determined the compliance of the patients. Antiepileptic serum levels were measured three times at intervals of at least two to four weeks apart, and their CV was calculated. We compared the CV between the compliant and non-compliant group in each AED(phenytoin, carbamazepine , valproic acid) and three drugs in the compliant group. The mean CVs of phenytoin, carbamazepine and valproic acid in the compliant group were 18.3+/-13.0, 15.2+/-10.2 and 23.8+/-8.9, respectively(mean+/-SD). The mean of CV in the compliant and the non-compliant group were 17.9+/-10.9 and 38.8+/-27.2, respectively. The CVs of the compliant group were significantly lower than those of the non-compliant group(p<0.05). However, CVs had no significant difference between three antiepileptic drugs. This study showed that CVs of AEDs were not different between each AEDs, even though they possess different pharmacokinetic properties. Therefore, the CV of one AED can be used in determining the compliance of the epileptics who are taking multiple AEDs.
Anticonvulsants ; Carbamazepine* ; Compliance ; Humans ; Outpatients ; Phenytoin* ; Surveys and Questionnaires ; Valproic Acid*

BACKGROUND: The purpose of this study was to assess the efficacy and safety of entacapone, a catechol-O-methyltransferase (COMT) inhibitor in Parkinson's disease (PD) patients with wearing-off phenomenon. METHODS: A total of 197 PD patients were included in this 2-month multi-center, randomized, placebo-controlled, double blind, parallel-group study. After a 2-week screening period, each patient was randomly allocated to receive either entacapone (n=98) or placebo (n=99) as an adjunct to levodopa. The efficacy was evaluated with the changes of "on" and "off" time percentage while awake, the reduction of the levodopa dose, Unified Parkinson's Disease Rating Scale (UPDRS), and the clinical global impression (CGI) by the examiner. RESULTS: The percentage of "on" time increased by 9.4 +/- 18.0% in the entacapone group, 7.4 +/- 15.6% in the placebo group. The percentage of "off" time was reduced by 8.6 +/- 16.9% in the entacapone group, 6.6 +/- 18.2% in the placebo group. These parameters did not show a statistical significance between the two groups. However, the levodopa dose was significantly reduced in the entacapone group (51.6 +/- 154.5 mg/day) compared with the placebo group (0.7 +/- 130.0 mg/day) (p=0.009). The total and motor scores of the UPDRS were significantly decreased in the entacapone group (p=0.039, p=0.017, respectively). The most common adverse drug reactions in the entacapone group were urine discoloration (22%), dyskinesia (13%), dizziness (7%). CONCLUSIONS: Entacapone was a safe and well-tolerated drug. Although the changes of "on" and "off" time were not significant, entacapone showed an overall significant beneficial effect in the PD patients with wearing-off phenomenon.
Catechol O-Methyltransferase ; Dizziness ; Double-Blind Method* ; Drug-Related Side Effects and Adverse Reactions ; Dyskinesias ; Humans ; Levodopa ; Mass Screening ; Parkinson Disease*