A Study on Protocol-based Treatment Change in Drug-resistant Epilepsy Patients in a Tertiary Care Center in Eastern India

Abstract

Background and Objectives: Management of drug-resistant epilepsy (DRE) remains challenging. A considerable subset of such patients who cannot access nonpharmacological treatment options relies on antiseizure medication (ASM) combination therapy, for which no standardized guidelines currently exist. This study aimed to determine the efficacy of treatment changes using a clinic-based strategic treatment protocol in patients with DRE. Furthermore, it sought to identify clinical factors associated with a positive patient response to these adjustments. Methods: We conducted a prospective observational study including 138 patients with DRE who were followed for 24 months. Seizure frequency was assessed at 3, 6, and 12 months. Results: A total of 469 drug-changing interventions were performed across the cohort (284 for focal epilepsy and 185 for generalized and unknown seizures). Key findings included: (1) Seizure reduction: Univariate analysis revealed a statistically significant reduction in seizure frequency at the 3-, 6-, and 12-month follow-ups (22% and 41% reduction at 6 and 12 months, respectively; P = 0.0146, P = 0.0014, and P = 0.0001, respectively). (2) Predictive factors: Multivariate analysis demonstrated that age at disease onset, disease duration, and number of ASMs prescribed both before the index date and at 6 and 12 months were statistically significant predictors of therapeutic response (P < 0.05). (3) Remission rates: At the 12-month follow-up after rescheduling, 19.56% (n = 27) of patients achieved complete seizure freedom. Conclusions: Modifying ASM regimens through a strategic protocol yielded significant improvements in seizure control in patients with DRE during the one-year follow-up period. Clinical and treatment-related factors independently predicted outcomes.