RESUMEN
Background: Epilepsy is one of the most common serious disorders of the brain, affecting about 50 million people worldwide, 80% of the burden of epilepsy is in the developing world. Therapeutic drug monitoring (TDM) is one of the major arms to maximize efficacy and minimize risk of overdosing. AIM: To compare clinical outcome between monitored and unmonitored dose of Phenytoin in patient of generalized tonic clonic seizure. Methods: Comparative study of 40 patients on phenytoin with therapeutic drug monitoring verses 40 patients on phenytoin without therapeutic drug monitoring of Generalized tonic clonic seizure were undertaken. For therapeutic drug monitoring, early morning sample (before taking morning dose) was collected, centrifuged, plasma separated and after that therapeutic level are monitored using HPLC. Sampling was done twice a month for one month than once a month for third and sixth month; samples were also taken abruptly in case of poor or no response to therapy, any adverse effect if noted or if any patient taking other medication in between. Evaluation of Efficacy is done by mean Seizure frequency reduction and comparison of side effect profile of the two groups. Results: Statistically significant difference is seen in TDM and non-TDM Group at 3 and 6 months; with percent reduction of mean seizure frequency 85.44% in TDM group compared to 43.81% in non- TDM group. Conclusions: The results of this comparative evaluation after the collection of data and its analysis confirms clinical impact of therapeutic drug monitoring of phenytoin monotherapy in patients of generalized tonic clonic seizures.