1Department of Neurology, Seth GS Medical College and KEM Hospital, Mumbai, India 2Department of Neurology, Trinity Acute Care Hospital, Chennai, India 3Department of Neurology, Criticare Multi Speciality Hospital and Research Centre, Mumbai, India 4Department of Neurology, Metro Multi Speciality Hospital, Noida, India 5Department of Neurology, Mata Chanan Devi Hospital, New Delhi, India 6Department of Neurology, Vivekananda Hospital, Hyderabad, India 7Department of Neurology, Lourdes Hospital, Kochi, India 8Department of Neurology, Sai Neurology Clinic, Lucknow, India 9Department of Neurology, Brain and Nerve Care, Bangalore, India 10Department of Neurology, Seven Hills Hospital, Visakhapatnam, India 11Department of Pharmacology and Therapeutics, Government Medical College, Eisai Pharmaceuticals India Pvt Ltd, Solapur, India 12Eisai Singapore Pte Ltd, Singapore
*Corresponding Author: Balaji Patil, Department of Pharmacology and Therapeutics, Government Medical College, Solapur, India.
Introduction: As very limited clinical data is available in Indian patients with Zonisamide initial monotherapy, a subgroup analysis of data from a prospective, post-marketing. A surveillance study was conducted to evaluate the efficacy and safety of Zonisamide as initial monotherapy in Indian adult patients.
Methods: A total of 655 patients were enrolled in a post-marketing surveillance study across 30 centers in India, out of which Zonisamide initial monotherapy was administered to 137 patients. This subgroup data were evaluated on the primary and secondary endpoints: median percentage reduction in seizure frequency and percentage responder rate and seizure-free patients over 24 weeks.
Results: Compared to baseline, the maximum percentage change in seizure frequency reduction was 90.98% at 24 weeks. The percentage of patients achieving overall responder rate and seizure freedom rate at 24 weeks was 84.67% and 59.12% respectively, whereas the percentage of patients achieving seizure freedom in focal impaired awareness (complex partial) and generalized motor (tonic-clonic) seizures was 64.10% and 66.67% respectively at 24 weeks. The most commonly reported adverse event was the loss of appetite in 13.87% of patients which was mild to moderate intensity, but 99.10% of patients had excellent tolerability to Zonisamide initial monotherapy.
Discussion: Because of the added clinical advantage in special patient populations, Zonisamide could be considered as a potential initial monotherapy drug for the treatment of focal onset and generalized seizures.
Citation:Balaji Patil., et al. “Efficacy and Safety of Zonisamide as Initial Monotherapy in Indian Patients with Epilepsy: A Subgroup Analysis of Prospective, Multicentre, Post-marketing Surveillance Study”. Acta Scientific Neurology 4.6 (2021): 29-38.