Acta Scientific Neurology (ASNE) (ISSN: 2582-1121)

Research Article Volume 4 Issue 5

Efficacy and Safety of Zonisamide as Initial Monotherapy in Indian Patients with Epilepsy: A Subgroup Analysis of Prospective, Multicentre, Post-marketing Surveillance Study

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

References

  1. Trinka E., et al. “Epilepsy in Asia: Disease burden, management barriers, and challenges”. Epilepsia 60 (2019): 7-21.
  2. Shorvon SD and Reynolds EH. “Unnecessary polypharmacy for epilepsy”. BMJ 1 (1977): 1635-1637.
  3. Shorvon SD and Reynolds EH. “Reduction of polypharmacy for epilepsy”. BMJ 2 (1979): 1023-1025.
  4. Brodie MJ., et al. “Patterns of treatment response in newly diagnosed epilepsy”. Neurology 20 (2012): 1548-1554.
  5. Privitera M. “Large clinical trials in epilepsy: funding by the NIH versus pharmaceutical industry”. Epilepsy Research 1 (2006): 52-56.
  6. Shorvon SD., et al. “One drug for epilepsy”. British Medical Journal 1 (1978): 474-476.
  7. Crawford P. “Best practice guidelines for the management of women with epilepsy”. Epilepsia 46 (2005): 117-124.
  8. Harms SL., et al. “Prevalence of appropriate and problematic antiepileptic combination therapy in older people in the nursing home”. Journal of the American Geriatrics Society 53 (2005): 1023-1028.
  9. Novak PH., et al. “Acute drug prescribing to children on chronic antiepilepsy therapy and the potential for adverse drug interactions in primary care”. British Journal of Clinical Pharmacology 59.6 (2005): 712-717.
  10. Wilfong AA., et al. “Zonisamide - a review of experience and use in partial seizures”. Neuropsychiatric Disease and Treatment 3 (2006): 269-280.
  11. Glauser T., et al. “Updated ILAE evi­dence review of antiepileptic drug efficacy and effectiveness as initial monotherapy for epileptic seizures and syndromes”. Epilepsia3 (2013): 551-563.
  12. Kumagai N. “Monotherapy for childhood epilepsies with zonisamide”. The Japanese Journal of Psychiatry and Neurology 45 (1991): 357-359.
  13. Kim DW., et al. “Long-term Retention Rate of Zonisamide in Patients With Epilepsy: An Observational Study”. Clinical Neuropharmacology 37 (2014): 133-135.
  14. Fukushima K and Seino M.A Long-term Follow-up of Zonisamide Monotherapy”. Epilepsia 47.11 (2006): 1860-1864.
  15. Dash A., et al. “Evaluation of safety and efficacy of zonisamide in adult patients with partial, generalized, and combined seizures: an open-labeled, noncomparative, observational Indian study”. Therapeutics and Clinical Risk Management 12 (2016): 327-334.
  16. Busner J and Targum SD. “The clinical global impressions scale: apply­ing a research tool in clinical practice”. Psychiatry (Edgmont)7 (2007): 28-37.
  17. Prabhoo R., et al. “Effi­cacy and tolerability of a fixed dose combination of methylcobalamin and pregabalin in the management of painful neuropathy”. North American Journal of Medical Sciences 11 (2012): 605-607.
  18. Kwan P and Brodie MJ. “Epilepsy after the first drug fails: substitution or add-on?” Seizure 7 (2000): 464-468.
  19. Leppik IE., et al. “Advances in antiepileptic drug treatments: a rational basis for selecting drugs for older patients with epilepsy”. Geriatrics 59.12 (2004): 14-24.
  20. Patsalos PN., et al. “The importance of drug interactions in epilepsy therapy”. Epilepsia4 (2002): 365-385.
  21. Tosches WA. “Long-term efficacy and safety of monotherapy and adjunctive therapy with zonisamide”. Epilepsy Behavior 3 (2006): 522-526.
  22. Yang Lu., et al. “Efficacy and Safety of Adjunctive Zonisamide in Adult Patients with Refractory Partial-Onset Epilepsy”. Clinical Drug Investigation4 (2011): 221-229.
  23. Brodie MJ., et al. “Comparison of levetiracetam and controlled-release carbamazepine in newly diagnosed epilepsy”. Neurology 68 (2007): 402-408.
  24. Baulac M., et al. “Efficacy and tolerability of zonisamide versus controlled-release carbamazepine for newly diagnosed partial epilepsy: a phase 3, randomised, double-blind, non-inferiority trial”. Lancet Neurology7 (2012): 579-588.
  25. Zonegran Summary of Product Characteristics.
  26. Hernandez-Diaz. “Comparative safety of antiepileptic drugs during pregnancy”. Neurology 21 (2012): 1692-1699.
  27. Trinka E., et al. “Safety and tolerability of zonisamide in elderly patients with epilepsy”. Acta Neurologica Scandinavica 128 (2013): 422-428.
  28. Brodie MJ., et al. “Zonisamide: its pharmacology, efficacy and safety in clinical trials”. Acta Neurologica Scandinavica 194 (2012): 19-28.
  29. Hoy SM. “Zonisamide: a review of its use in the management of adults with partial seizures”. Drugs12 (2013): 1321-1338.
  30. Griffith SG and Dai Y. “Effect of zonisamide on the pharmacokinetics and pharmacodynamics of a combination ethinyl estradiol-norethindrone oral contraceptive in healthy women”. Clinical Therapeutics 12 (2004): 2056-2065.

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.




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