Comparison of Efficacy of Sustained Release Formulation of Valproate and Topiramate Monotherapy for Control of Epilepsy in Epileptic Patients

Abstract

Epilepsy is one of the most common neurological disorders, affecting approximately 50 million people worldwide. Medications are still the most common therapeutic choice for seizure control. In clinical practice anti-epileptic drugs that were licensed before valproate are called traditional antiepileptic drugs while those licensed after valproate are called new generation antiepileptic drugs. Objective:  To compare the efficacy of sustained release formulation of valproate and topiramate monotherapy for control of epilepsy in elliptic patients. Study design: Randomized controlled trial. Setting: OPD, Medical Department, Allied hospital Faisalabad. Duration of study: 6 months duration after approval of synopsis from 30-07-2015 to 30-11-2015. Methodology: Patients with definite diagnosis of epilepsy with generalized tonic clonic seizures between 13 to 17 years of both genders were recruited from medical ward and OPD who fulfilled the inclusion were enrolled in the study. After approval from hospital ethical review committee. Informed consent was taken from each participant of the study. Patients were divided randomly into group A and group B using computer generated random number table. Group A was given sustained released formulation of valproate 500mg once a day and titrated up with weekly increments of 250mg/per day up to maximum of 2000mg/day in two divided doses to control seizures. Group B was given topiramate 25mg twice daily and titrated up in increments of 50 mg weekly to control seizures up to a maximum of 800 mg per day in 2 divided doses. Follow up was done by telephonic contact by asking about control of generalized tonic clonic seizures. Data was collected through self-conducted interviews using a standardized proforma. Efficacy was measured in terms of control of seizures. Results: In our study out of 330 cases, 165 in each group , 41.82%(n=69) in group-A and 40%(n=66) group-B were between 13-40 years of age while 58.18%(n=96) in group-A and 60%(n=99) in group-B were between 41-70 years of age ,mean was calculated as 41.79±10.66 and 42.12±10.37 years, 61.21%(n=101) in group-A and 54.55%(n=90) in group-B were male while 38.79%(n=64) in group-A and 45.45%(n=75) in group-B were females. Comparison of efficacy in both groups shows that 39.39%(n=65) in group-A AND 25.45%9(n=42) in group-B were treated effectively, p value was calculated as 0.006 showing a significant difference. Conclusion: We concluded that the efficacy of sustained release formulation of valproate is significantly higher when compared topiramate monotherapy for control of epilepsy in epileptic patients.