Abstract

CROSS – SECTIONAL STUDY OF ADVERSE EVENTS ASSOCIATED WITH ANTIEPILEPTIC DRUG IN TERTIARY CARE SETTING

Fathimath Shamliya P., Muhsina, Sumayya Thesney K., Surya K., Neetha Balaram, U. S. Jijith*, Nayana Susan

Abstract

Background: Antiepileptic drugs (AEDs) are essential for seizure control in epilepsy, yet they are frequently associated with adverse events (AEs) that can significantly affect patient adherence and quality of life. However, data on the prevalence and impact of AED- related AEs in tertiary care settings remain limited. Objective: To assess the prevalence, pattern, and predictors of adverse events associated with AEDs and evaluate their impact on quality of life among epilepsy patients in a tertiary care hospital. Methods: This cross-sectional study was conducted over three months at the Neurology Department of Government Medical College, Kozhikode. A total of 136 patients with epilepsy on AED therapy for at least six months were recruited. Data were collected using structured questionnaires and medical record reviews. Statistical analyses included chi-square tests and logistic regression using SPSS. Results: Among 136 participants, 58.8% reported AEs, with aggression, somnolence, fatigue, and gastrointestinal disturbances being the most common. Levetiracetam and clobazam were the AEDs most frequently associated with behavioural AEs. Duration of AED therapy was the only variable significantly associated with AEs (p = 0.045). Quality of life was significantly lower in patients reporting AEs across all domains (p < 0.001). Despite AEs, 70% of affected patients did not consult healthcare providers, and only 30% received management interventions. Conclusion: A significant proportion of epilepsy patients on AEDs experience adverse events, which negatively impact quality of life and adherence. Duration of therapy is a key predictor of AEs. Regular monitoring, patient education, and individualized treatment strategies are crucial for optimizing epilepsy care.

Keywords: Monotherapy, Polytherapy, Adverse events, Adverse events on Domain Specific, Quality of life Scores, Anti-epileptic therapy.