Short-term efficacy and safety of valproate sustained-release formulation in newly diagnosed partial epilepsy VIPe-study. A multicenter observational open-label study (original) (raw)

Uploaded (2016) | Journal: Saudi medical journal

Abstract

To evaluate the efficacy and safety of valproate (VPA) sustained-released in monotherapy across all ages in newly-diagnosed epileptic patients with partial seizures (PS) with or without secondary generalization. This was a multicenter, prospective, observational, open-label, non-comparative study involving the Gulf Cooperation Council (GCC) countries except the Kingdom of Saudi Arabia, and was performed between November 2004 and May 2006. Adults and children (6 years or older with newly diagnosed partial epilepsy [PE]) with or without secondary generalization were enrolled. The primary efficacy parameter was 6 month-remission rate (proportion of seizure-free patients in relation to total number of retained patients). Secondary efficacy parameters included: 6 month-retention rate, investigator's clinical global impression rating, maximal effective dose and safety profile. Seventy-seven patients were enrolled; 56% adults and 44% children, with average duration of epilepsy of 5 mon...

FAQs

sparkles

AI

What is the efficacy rate of valproate sustained-release formulation in seizure control?add

The study finds that 87% of patients became completely seizure-free after 6 months of treatment with valproate sustained-release. This rate was notably higher in pediatric patients at 93% compared to 82% in adults.

How does valproate's efficacy compare across different age groups?add

Marked improvement without adverse drug reactions was noted in 67% of children and 51% of adults. This suggests a differential efficacy in seizure control favoring pediatric patients.

What were the main side effects reported during the valproate study?add

Fifteen patients reported adverse drug reactions during the study, mainly hair loss and tremor. Notably, the incidence of reported ADRs was less than 20%, indicating a favorable safety profile.

How was treatment retention measured in the valproate study?add

The treatment retention rate was high at 81%, calculated based on the proportion of patients who completed the 6-month study. Various dropout reasons included ADRs and loss to follow-up.

What demographic characteristics were observed in the study population?add

The average age of study participants was 24 years, with 62% experiencing partial seizures with secondary generalization. Most patients (75%) had no relevant medical history and normal neurological examinations.

Loading...

Loading Preview

Sorry, preview is currently unavailable. You can download the paper by clicking the button above.

References (23)

  1. Kotsopoulos IA, van Merode T, Kessels FG, de Krom MC, Knottnerus JA. Systematic review and meta-analysis of incidence studies of epilepsy and unprovoked seizures. Epilepsia 2002; 43: 1402-1409.
  2. Sander JW, Shorvon SD. Epidemiology of the epilepsies. J Neurol Neurosurg Psychiatry 1996; 61: 433-443.
  3. Brodie MJ, Kwan P. Staged approach to epilepsy management. Neurology 2002; 58 (suppl 5): S2-S8.
  4. Brodie MJ, Dichter MA. Antiepileptic drugs. N Engl J Med 1996; 334: 168-175.
  5. Perucca E. Pharmacological and therapeutic properties of valproate: a summary after 35 years of clinical experience. CNS Drugs 2002; 16: 695-714.
  6. Verity CM, Hosking G, Easter DJ. A multicentre comparative trial of sodium valproate and carbamazepine in paediatric epilepsy. The Paediatric EPITEG Collaborative Group. Dev Med Child Neurol 1995; 37: 97-108.
  7. Heller AJ, Chesterman P, Elwes RD, Crawford P, Chadwick D, Johnson AL, et al. Phenobarbitone, phenytoin, carbamazepine, or sodium valproate for newly diagnosed adult epilepsy: a randomized comparative monotherapy trial. J Neurol Neurosurg Psychiatry 1995; 58: 44-50.
  8. de Silva M, MacArdle B, McGowan M, Hughes E, Stewart J, Neville BG, et al. Randomized comparative monotherapy trial of phenobarbitone, phenytoin, carbamazepine, or sodium valproate for newly diagnosed childhood epilepsy. Lancet 1996; 347: 709-713.
  9. Doughty J, Baker GA, Jacoby A, Lavaud V. Compliance and satisfaction with switching from an immediate-release to sustained-release formulation of valproate in people with epilepsy. Epilepsy Behav 2003; 4: 710-716.
  10. Deleu D, Aarons L, Ahmed IA. Population pharmacokinetics of free-carbamazepine in adult Omani epileptic patients. Eur J Clin Pharmacol 2001; 57: 243-248.
  11. Deleu D, Aarons L, Ahmed IA. Estimation of population pharmacokinetic parameters of free-phenytoin in adult epileptic patients. Arch Med Res 2005; 36: 49-53. (Erratum Arch Med Res 2005; 36: 186)
  12. Commission on Classification and Terminology of the International League Against Epilepsy. Proposal for revised clinical and electroencephalographic classification of epileptic seizures. Epilepsia 1981; 22: 489-501.
  13. Commission on Classification and Terminology of the International League Against Epilepsy. Proposal for revised classification of epilepsies and epileptic syndromes. Epilepsia 1989; 30: 389-399.
  14. Hanssens Y, Deleu D, Al Balushi K, Al Hashar A, Al- Zakwani I. Drug utilization pattern of anti-epileptic drugs: a pharmacoepidemiologic study in Oman. J Clin Pharm Ther 2002; 27: 357-364.
  15. Hanssens Y, Al-Asmi A, Al-Busaidi I, Deleu D. Efficacy and tolerability of antiepileptic drugs in an Omani epileptic population. Clin Neurol Neurosurg 2006; 108: 532-538.
  16. Aziz H, Guvener A, Akhtar SW, Hasan KZ. Comparative epidemiology of epilepsy in Pakistan and Turkey: population-based studies using identical protocols. Epilepsia 1997; 38: 716-722.
  17. Abduljabbar M, Ogunniyi A, Daif AK, Al-Tahan A, Al-Bunyan M, Al-Rajeh S. Epilepsy classification and factors associated with control in Saudi adult patients. Seizure 1998; 7: 501-504.
  18. Sander JW. Some aspects of prognosis in the epilepsies: a review. Epilepsia 1993; 34: 1007-1016.
  19. Mattson RH, Cramer JA, Collins JF. Prognosis for total control of complex partial and secondarily generalized tonic clonic seizures. Department of Veterans Affairs Epilepsy Cooperative Studies No. 118 and No. 264 Group. Neurology 1996; 47: 68-76.
  20. Collaborative Group for Epidemiology of Epilepsy. Adverse reactions to antiepileptic drugs: a follow-up study of 355 patients with chronic antiepileptic drug treatment. Epilepsia 1988; 29: 787-793.
  21. Heaney DC, Shorvon SD, Sander JW, Boon P, Komarek V, Marusic P, et al. Cost minimization analysis of antiepileptic drugs in newly diagnosed epilepsy in 12 European countries. Epilepsia 2000; 41 Suppl 5: S37-S44.
  22. Perucca E, Tomson T. Monotherapy trials with the new antiepileptic drugs: study designs, practical relevance and ethical implications. Epilepsy Res 1999; 33: 247-262.
  23. Das CP, Sawhney IM, Lal V, Prabhakar S. Risk of recurrence of seizures following single unprovoked idiopathic seizure. Neurol India 2000; 48: 357-360.