Abstract
INTRODUCTION: With the advancement of therapeutics, newer antiepileptic drugs (AEDs) like Levetiracetam (LEV), with good therapeutic efficacy and tolerability are available. But unfortunately, therapeutic drug monitoring is not routinely done in India for these drugs. OBJECTIVES: The objective of this study is to determine the range of serum levels of LEV in patients at stabilized doses and correlate them with their clinical course. MATERIALS AND METHODS: Patients with epilepsy and started on LEV were enrolled from the Neurology Department after the Ethics Committee approval. Serum levels of LEV were estimated using high-performance liquid chromatography and correlated with patient demographics, dosage, dosage forms, concomitant AEDs, compliance of the patient, therapeutic effect, adverse drug reactions (ADRs), and suspected toxicity. RESULTS: Serum levels of LEV ranged from 0.4 to 102.2 μg/ml at different time points and demonstrated a negligible positive correlation with age of the patients (r = 0.12) but negligible negative correlation with bodyweight (r = -0.19). No conclusive relationship could be established for dose, gender, dosage forms, clinical efficacy (seizure frequency), ADRs, and toxicity. Compliance was verified in all the patients. Levels were found to reduce with the use of concomitant enzyme inducer drugs (56.78%) whereas increase with valproic acid (7.8%). CONCLUSION: These findings emphasize the need for monitoring the serum levels of newer AEDs like LEV considering the various parameters studied here, so as to maintain the therapeutic efficacy by preventing under or over dosage and to generate a broader database of serum levels of LEV in the Indian population to help appropriate prescribing with more confidence.