Sangeeta Ravat¹, Avathvadi Venkatesan Srinivasan², Ashutosh Shetty³, Vivek Kumar⁴, Renu Achtani⁵, Vivek Narain Mathur⁶, Boby Varkey Maramattom⁷, Veeresh Bajpai⁸, Nanjappa C Manjunath⁹, Randhi Venkata Narayana¹⁰, Balaji Patil¹¹*, Parvan Shetty¹¹, Darshana Dighe¹¹ and Amitabh Dash¹²

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.

Received: March 16, 2021; Published: May 11, 2021

Abstract

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.

Keywords: Zonisamide; Monotherapy; Responder Rate; Focal Onset Seizures; Generalized Seizures

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Citation

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.

Copyright

Copyright: © 2021 Balaji Patil., et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.